23 Lead Pharmaceutical Quality Assurance Manager jobs in whatjobs
Lead Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client is seeking an accomplished and detail-oriented Lead Pharmaceutical Quality Assurance Manager to ensure the highest standards of quality and compliance in pharmaceutical manufacturing and development. This is a critical, fully remote position for an experienced professional who can lead a virtual team and oversee all quality assurance activities. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) in adherence to global regulatory standards (e.g., GMP, FDA, EMA). The ideal candidate will have extensive experience in pharmaceutical quality control, auditing, and regulatory affairs. Your responsibilities will include conducting internal and external audits, managing deviations and CAPAs, overseeing product release, and ensuring that all pharmaceutical products meet stringent quality specifications. You will lead and mentor a team of quality assurance specialists, providing guidance and support to foster a culture of continuous improvement and compliance. This role demands exceptional analytical skills, strong problem-solving capabilities, and excellent communication and interpersonal abilities, enabling effective collaboration with diverse teams and regulatory bodies. Proficiency in quality management software and a thorough understanding of pharmaceutical manufacturing processes are essential. The successful candidate will be a self-starter, capable of managing multiple priorities and driving quality initiatives within a remote-first operational framework. This is an exceptional opportunity to shape the quality landscape of a leading pharmaceutical company and contribute to the delivery of safe and effective medicines.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in line with global regulatory standards (e.g., GMP, ISO).
- Lead and mentor a team of Quality Assurance professionals in a remote setting.
- Oversee and conduct internal and external audits of manufacturing facilities, suppliers, and processes.
- Manage deviation investigations, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA).
- Ensure compliance with all relevant pharmaceutical regulations and guidelines.
- Review and approve batch records, validation protocols, and other critical quality documents.
- Manage product release processes to ensure products meet all quality and regulatory requirements.
- Develop and deliver quality training programs for staff.
- Act as a key point of contact for regulatory inspections and agency interactions.
- Drive continuous improvement initiatives within the QA department and across the organization.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
- Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance, with at least 2 years in a leadership role.
- In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in auditing, CAPA management, and QMS implementation.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication, leadership, and interpersonal skills.
- Proficiency in quality management software and tools.
- Ability to manage projects and teams effectively in a remote environment.
This advertiser has chosen not to accept applicants from your region.
0
Lead Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client is looking for an accomplished and detail-oriented Lead Pharmaceutical Quality Assurance Manager to oversee and enhance our quality management systems. This role is fully remote, allowing you to leverage your expertise from any location. You will be responsible for ensuring that all pharmaceutical products meet stringent regulatory standards and internal quality benchmarks. This includes developing, implementing, and maintaining comprehensive QA protocols, conducting internal audits, managing external audits from regulatory bodies, and driving continuous improvement initiatives across the organization. The ideal candidate possesses extensive experience in the pharmaceutical industry, with a deep understanding of GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), and relevant regulatory frameworks (e.g., FDA, EMA, KEBS). You will lead a team of QA professionals, providing guidance, mentorship, and fostering a culture of quality excellence. Responsibilities include reviewing and approving batch records, investigating deviations and out-of-specification results, managing change controls, and overseeing validation processes. You will also play a critical role in ensuring product safety and efficacy throughout the product lifecycle. Strong analytical skills, excellent problem-solving abilities, and exceptional communication are essential. This remote position offers the flexibility to work from anywhere while making a significant contribution to the quality and integrity of pharmaceutical products. The successful candidate will be a proactive leader committed to upholding the highest standards of quality in a dynamic, fast-paced environment. We are seeking individuals who are passionate about safeguarding public health through superior quality control. This role is essential for maintaining our reputation for excellence and compliance in the pharmaceutical sector. The position is based remotely, offering a flexible work arrangement. This role is located in Ruiru, Kiambu, KE .
This advertiser has chosen not to accept applicants from your region.
1
Lead Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a forward-thinking pharmaceutical company, is seeking a Lead Pharmaceutical Quality Assurance Manager to oversee critical quality operations. This is a fully remote role, providing a unique opportunity to shape quality standards from anywhere. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) across all pharmaceutical product development and manufacturing stages. This includes ensuring compliance with global regulatory requirements such as GMP, ICH guidelines, and local health authority regulations.
Your leadership will guide a team of quality professionals, fostering a culture of continuous improvement and quality excellence. You will conduct internal audits, manage external inspections, and oversee the investigation of deviations and CAPAs. The role involves close collaboration with R&D, manufacturing, and regulatory affairs departments to ensure product integrity and patient safety. Strong strategic thinking, excellent leadership skills, and a deep understanding of the pharmaceutical industry are essential for success. You will be instrumental in driving quality initiatives, managing risk, and ensuring the consistent delivery of high-quality pharmaceutical products. We are looking for a proactive leader who can navigate complex regulatory landscapes and implement effective quality strategies within a remote-first setting.
Responsibilities:
Your leadership will guide a team of quality professionals, fostering a culture of continuous improvement and quality excellence. You will conduct internal audits, manage external inspections, and oversee the investigation of deviations and CAPAs. The role involves close collaboration with R&D, manufacturing, and regulatory affairs departments to ensure product integrity and patient safety. Strong strategic thinking, excellent leadership skills, and a deep understanding of the pharmaceutical industry are essential for success. You will be instrumental in driving quality initiatives, managing risk, and ensuring the consistent delivery of high-quality pharmaceutical products. We are looking for a proactive leader who can navigate complex regulatory landscapes and implement effective quality strategies within a remote-first setting.
Responsibilities:
- Develop, implement, and manage the company's Quality Management System (QMS) in compliance with global regulatory standards.
- Lead and mentor a team of Quality Assurance professionals, fostering a high-performance culture.
- Oversee and conduct internal audits and inspections of manufacturing facilities, R&D labs, and other relevant departments.
- Manage external regulatory inspections (e.g., FDA, EMA) and ensure successful outcomes.
- Investigate product quality complaints, deviations, and out-of-specification (OOS) results; implement effective Corrective and Preventive Actions (CAPA).
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards.
- Collaborate with cross-functional teams to ensure quality is integrated into product lifecycle management.
- Manage vendor qualification and ensure the quality of outsourced services and materials.
- Develop and deliver quality training programs to relevant personnel.
- Stay updated on regulatory changes and industry best practices to ensure continuous compliance and improvement.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8 years of progressive experience in Pharmaceutical Quality Assurance and Quality Control.
- Extensive knowledge of GMP, ICH guidelines, and other international regulatory requirements.
- Proven experience in managing regulatory inspections and successful audits.
- Strong leadership and team management skills with a track record of building high-performing teams.
- Excellent analytical, problem-solving, and decision-making abilities.
- Exceptional written and verbal communication skills, with the ability to communicate complex quality issues effectively.
- Proficiency in quality management software and tools.
- Experience in managing deviations, OOS investigations, and CAPA systems.
- Ability to thrive in a remote work environment, demonstrating self-motivation and strong organizational skills.
This advertiser has chosen not to accept applicants from your region.
2
Lead Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a prestigious pharmaceutical company at the forefront of medical innovation, is actively seeking a highly experienced and dedicated Lead Pharmaceutical Quality Assurance Manager to join their completely remote workforce. This critical role will oversee the development, implementation, and maintenance of robust quality management systems, ensuring strict adherence to regulatory standards and the highest levels of product integrity. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, regulatory compliance (FDA, EMA, WHO GMP), and a passion for upholding the highest quality benchmarks in a virtual setting.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop, implement, and manage comprehensive quality assurance and quality control programs for pharmaceutical products.
- Ensure compliance with all relevant national and international pharmaceutical regulations, guidelines, and standards, including GMP, GCP, and GLP.
- Oversee the entire lifecycle of quality documentation, including SOPs, batch records, validation protocols, and deviation reports.
- Conduct internal audits and host external regulatory inspections to ensure readiness and compliance.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out-of-Specification) results, implementing effective solutions.
- Manage product quality reviews and release processes.
- Lead and mentor a team of QA professionals remotely, fostering a culture of quality excellence.
- Collaborate with R&D, Manufacturing, and Regulatory Affairs departments to ensure quality is integrated throughout product development and commercialization.
- Monitor industry trends and regulatory changes, updating quality systems accordingly.
- Serve as a subject matter expert on quality-related matters for internal and external stakeholders.
Qualifications:
- Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Minimum of 8 years of progressive experience in pharmaceutical quality assurance and quality control, with at least 3 years in a leadership capacity.
- Extensive knowledge of pharmaceutical manufacturing processes, analytical testing, and validation methodologies.
- In-depth understanding of GMP, ICH guidelines, and global regulatory requirements.
- Proven experience in managing audits and inspections from regulatory agencies.
- Exceptional analytical, problem-solving, and decision-making skills.
- Outstanding written and verbal communication skills, with the ability to articulate complex technical information clearly and concisely.
- Demonstrated ability to lead and motivate remote teams effectively.
- Proficiency in quality management software and electronic document control systems.
- A strong commitment to patient safety and product quality within the pharmaceutical industry .
This advertiser has chosen not to accept applicants from your region.
3
Lead Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical company committed to improving health outcomes, is seeking a highly motivated and experienced Lead Pharmaceutical Quality Assurance Manager. This is a pivotal, fully remote role that will oversee the quality assurance functions across our client's diverse product lines. The successful candidate will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) in compliance with global regulatory standards (e.g., GMP, GDP, ICH guidelines). You will lead a team of QA professionals, ensuring adherence to strict quality protocols throughout the product lifecycle, from research and development to manufacturing and distribution. Key responsibilities include managing internal and external audits, conducting risk assessments, investigating deviations and out-of-specification results, and implementing corrective and preventive actions (CAPAs). The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality control principles. You must have exceptional leadership skills, the ability to drive continuous improvement, and a meticulous attention to detail. This role demands strong analytical skills to interpret complex data, resolve quality issues, and make informed decisions that uphold the highest standards of product safety and efficacy. This is an excellent opportunity for a seasoned QA professional to make a significant impact in a remote-first environment, contributing to the development and delivery of life-saving medications. The work involves significant interaction with regulatory bodies and internal stakeholders, all managed remotely.
Responsibilities:
Responsibilities:
- Lead and manage the Quality Assurance department, ensuring compliance with all relevant pharmaceutical regulations and standards.
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Oversee all aspects of batch record review, product release, and stability testing programs.
- Conduct internal audits and host regulatory inspections, ensuring all findings are addressed promptly.
- Investigate deviations, customer complaints, and product quality issues, implementing effective CAPAs.
- Manage the change control process and ensure that all changes are assessed for their impact on product quality.
- Provide training and mentorship to QA staff.
- Collaborate with R&D, manufacturing, and regulatory affairs to ensure product quality throughout its lifecycle.
- Stay updated on evolving regulatory requirements and industry best practices.
- Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 10 years of progressive experience in pharmaceutical Quality Assurance.
- Extensive knowledge of cGMP, GDP, and ICH guidelines.
- Proven experience in managing regulatory inspections and audits (e.g., FDA, EMA).
- Strong leadership, team management, and interpersonal skills.
- Excellent analytical, problem-solving, and decision-making abilities.
- Proficiency in quality risk management principles.
- Exceptional written and verbal communication skills.
This advertiser has chosen not to accept applicants from your region.
4
Lead Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client is looking for a highly experienced and meticulous Lead Pharmaceutical Quality Assurance Manager to join their innovative and growing team. This is a remote-first position, offering the unique opportunity to oversee quality operations from anywhere. You will be responsible for ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, adhering to global regulatory requirements and internal quality management systems. This role demands a deep understanding of pharmaceutical manufacturing processes, quality control methodologies, and regulatory compliance.
Responsibilities:
Qualifications:
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with international standards (e.g., GMP, ISO).
- Oversee all quality assurance activities, including batch record review, deviation management, change control, and CAPA (Corrective and Preventive Actions).
- Lead and mentor a team of Quality Assurance professionals, fostering a culture of continuous improvement and quality excellence.
- Conduct internal audits and participate in external audits by regulatory authorities and customers.
- Ensure that all manufacturing and testing processes adhere to established procedures and regulatory guidelines.
- Review and approve validation protocols and reports for equipment, processes, and analytical methods.
- Manage product quality complaints and ensure timely and effective investigations and resolutions.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure quality is integrated throughout the product lifecycle.
- Stay updated on the latest regulatory changes and industry best practices, ensuring the QMS remains current and effective.
- Prepare and present quality metrics and reports to senior management.
- Provide quality oversight for contract manufacturing organizations (CMOs) as applicable.
Qualifications:
- Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related life science field.
- A minimum of 8-10 years of experience in pharmaceutical quality assurance and quality control, with at least 3 years in a managerial or supervisory role.
- Extensive knowledge of cGMP (current Good Manufacturing Practices) regulations and guidelines (e.g., FDA, EMA).
- Proven experience in developing and implementing robust QMS.
- Demonstrated success in leading audits and inspections.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent leadership, communication, and interpersonal skills, with the ability to motivate and guide a remote team.
- Proficiency in pharmaceutical software and data analysis tools.
- Experience with sterile manufacturing and/or biologics is a significant advantage.
- Ability to work independently and make sound decisions in a remote work environment.
This advertiser has chosen not to accept applicants from your region.
5
Lead Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a prestigious pharmaceutical company, is looking for a Lead Pharmaceutical Quality Assurance Manager to spearhead their QA initiatives. This critical role is entirely remote, allowing you to contribute your expertise from anywhere. You will be responsible for establishing and maintaining the highest standards of quality across all pharmaceutical product development and manufacturing processes. Your duties will encompass developing and implementing comprehensive quality management systems, ensuring compliance with national and international regulatory guidelines (e.g., FDA, EMA), and overseeing all aspects of quality control and assurance. This includes conducting internal audits, managing external audits, leading investigations into deviations and non-conformances, and implementing corrective and preventive actions (CAPA). You will also play a vital role in training and mentoring QA staff, fostering a culture of quality excellence within the organization. The ideal candidate will have a proven track record in pharmaceutical quality assurance, a thorough understanding of GMP, GCP, and GLP, and strong analytical and problem-solving skills. Experience with electronic quality management systems (eQMS) is a significant advantage. This remote position requires exceptional organizational skills, meticulous attention to detail, and the ability to effectively manage a distributed team. You will be a key player in ensuring the safety, efficacy, and integrity of our client's pharmaceutical products. The opportunity to shape quality policies and contribute to life-saving medications makes this a rewarding career move. You will collaborate closely with R&D, manufacturing, and regulatory affairs departments to ensure seamless product lifecycle management. Your insights will be crucial in continuous improvement initiatives and risk management strategies. This is a leadership position that offers significant professional growth and the chance to work with a globally recognized organization committed to improving health outcomes. We are seeking a candidate who is not only proficient in QA principles but also a strategic thinker capable of navigating the complexities of the pharmaceutical industry. Your ability to influence stakeholders and drive positive change will be paramount to success in this role. Join a team dedicated to excellence and innovation in pharmaceutical sciences.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Lead pharmaceutical quality assurance manager Jobs in Kenya !
6
Lead Pharmaceutical Quality Assurance Manager
Posted 12 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and dedicated Lead Pharmaceutical Quality Assurance Manager to oversee all quality control and assurance operations at their facility in Nyeri, Nyeri, KE . This pivotal role demands a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory compliance within the pharmaceutical industry. The successful candidate will be responsible for developing, implementing, and maintaining robust quality management systems to ensure product safety, efficacy, and consistency. You will lead a team of quality professionals, providing guidance, training, and performance management. Key responsibilities include conducting regular internal audits, reviewing batch records, investigating deviations and out-of-specification results, and implementing corrective and preventive actions (CAPAs). The Lead QA Manager will also play a critical role in regulatory inspections, ensuring the facility meets all national and international pharmaceutical standards. This position requires meticulous attention to detail, strong analytical and problem-solving skills, and the ability to make critical decisions in high-stakes situations. You will collaborate closely with production, R&D, and regulatory affairs departments to drive a culture of quality throughout the organization. Experience in developing and validating analytical methods, stability studies, and product release processes is essential. The ideal candidate will have a proven track record of successfully managing quality systems in a pharmaceutical manufacturing environment and a thorough knowledge of relevant regulatory guidelines from bodies such as the Pharmacy and Poisons Board (PPB) and potentially international equivalents. This is a challenging yet rewarding opportunity to shape the quality landscape of a growing pharmaceutical company and ensure the delivery of safe and effective medicines.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop, implement, and manage comprehensive Quality Management Systems (QMS).
- Ensure compliance with GMP, GLP, and other relevant regulatory standards.
- Lead and mentor the Quality Assurance team.
- Conduct internal audits and oversee external regulatory inspections.
- Review and approve batch manufacturing records and release of finished products.
- Investigate deviations, out-of-specification results, and customer complaints.
- Develop and implement Corrective and Preventive Actions (CAPA).
- Oversee validation activities for processes, equipment, and analytical methods.
- Manage stability programs and product lifecycle quality.
- Collaborate with cross-functional teams to foster a quality-centric culture.
Qualifications:
- Master's or PhD in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8 years of progressive experience in Pharmaceutical Quality Assurance and Quality Control.
- Extensive knowledge of GMP, ICH guidelines, and regulatory requirements.
- Proven experience in leading QA teams and managing QMS.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional communication and interpersonal abilities.
- Experience with regulatory body inspections.
This advertiser has chosen not to accept applicants from your region.
7
Lead Pharmaceutical Quality Assurance Manager
Posted 13 days ago
Job Viewed
Job Description
Our client is looking for a dynamic and experienced Lead Pharmaceutical Quality Assurance Manager to spearhead their quality control initiatives. This is a pivotal, fully remote leadership role that requires extensive knowledge of pharmaceutical manufacturing standards and regulatory compliance. You will be instrumental in developing, implementing, and maintaining the company's comprehensive Quality Management System (QMS) across all operations. Your primary focus will be on ensuring that all products meet stringent quality, safety, and efficacy standards, adhering to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant international guidelines. Responsibilities include overseeing batch record reviews, deviation investigations, change control processes, and CAPA management. You will lead audits, both internal and external, and collaborate with regulatory bodies to ensure ongoing compliance. This role involves significant interaction with R&D, manufacturing, and supply chain departments to foster a culture of quality throughout the organization. You will also be responsible for training and mentoring QA personnel, driving continuous improvement initiatives, and managing the validation of equipment and processes. The ideal candidate possesses exceptional leadership abilities, a meticulous attention to detail, and a deep understanding of pharmaceutical product development and lifecycle management. Strong analytical skills, excellent communication, and the capacity to make critical decisions are paramount. This is an exceptional opportunity to shape the quality framework of a growing pharmaceutical company from a remote setting. While the role is primarily remote, maintaining close communication with teams and understanding the operational context related to Garissa, Garissa, KE is important for strategic alignment.
This advertiser has chosen not to accept applicants from your region.
8
Lead Pharmaceutical Quality Assurance Manager
Posted 13 days ago
Job Viewed
Job Description
Our client, a dynamic pharmaceutical company, is seeking a highly experienced Lead Pharmaceutical Quality Assurance Manager to ensure the highest standards of quality and compliance across all operations. This is a fully remote role, allowing you to oversee critical quality systems from anywhere. The successful candidate will be responsible for developing, implementing, and maintaining robust Quality Management Systems (QMS) in accordance with regulatory requirements (e.g., FDA, EMA, WHO GMP). This includes establishing procedures for product development, manufacturing, testing, and distribution. You will lead quality audits, manage deviations and CAPAs, and ensure adherence to all relevant pharmaceutical regulations and industry best practices. The role demands extensive knowledge of GMP principles, validation processes, and regulatory affairs within the pharmaceutical industry. You will be responsible for training quality personnel, collaborating with cross-functional teams (e.g., R&D, manufacturing, regulatory affairs), and providing guidance on quality-related matters. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A minimum of 8 years of progressive experience in pharmaceutical quality assurance or quality control, with at least 3 years in a leadership or supervisory role, is required. Strong analytical skills, meticulous attention to detail, and excellent problem-solving abilities are essential. You must have a deep understanding of quality risk management and a proven ability to drive continuous improvement in quality systems. Experience with electronic QMS and data integrity principles is highly desirable. This is a critical role in safeguarding product quality, patient safety, and regulatory compliance, contributing significantly to the company's reputation and success in the pharmaceutical market.
This advertiser has chosen not to accept applicants from your region.
9