151 Senior Pharmaceutical Quality Assurance Manager jobs in whatjobs
Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a leading innovator in the pharmaceutical industry, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to join their expanding operations. This is a pivotal, fully remote position requiring a deep commitment to upholding the highest standards of quality and compliance. The successful candidate will be responsible for developing, implementing, and maintaining the company's quality management system in accordance with GMP, GCP, and other relevant regulatory guidelines. Key duties include overseeing all QA activities, conducting internal and external audits, managing deviations and CAPA systems, and ensuring the readiness for regulatory inspections. You will also be involved in product lifecycle management, risk assessments, and validation activities. This role demands an expert understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality control principles. The ability to lead cross-functional teams, mentor junior QA staff, and drive continuous improvement initiatives is essential. Strong analytical and problem-solving skills are required to identify and resolve quality issues effectively. Excellent written and verbal communication skills are necessary for preparing reports, documentation, and liaising with regulatory bodies and stakeholders. As a remote role, exceptional organizational skills and the ability to work autonomously, manage time effectively, and maintain rigorous attention to detail are critical. This is an exceptional opportunity for a seasoned QA professional to make a significant contribution to the development and manufacturing of life-saving medicines from a remote location. You will play a crucial role in ensuring product safety, efficacy, and compliance across all stages of development and production.
This advertiser has chosen not to accept applicants from your region.
0
Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical entity, is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to lead our remote QA operations. This crucial role involves ensuring compliance with all regulatory standards, including GMP, GxP, and other relevant guidelines, for all pharmaceutical products. You will be responsible for developing, implementing, and maintaining the quality management system, overseeing audits, managing deviations, and driving continuous improvement initiatives. The ideal candidate will have a deep understanding of pharmaceutical manufacturing processes, quality control principles, and regulatory affairs. This is a fully remote position, allowing you to contribute your expertise from anywhere in Kenya while ensuring the highest standards of quality and safety in pharmaceutical development and production.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with global regulatory requirements.
- Oversee all aspects of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) compliance.
- Plan and conduct internal and external audits, managing corrective and preventive actions (CAPA).
- Review and approve batch records, validation protocols, and other critical quality documentation.
- Manage deviation investigations, change controls, and product quality reviews.
- Train staff on quality assurance principles, GMP, and regulatory compliance.
- Liaise with regulatory authorities during inspections and submissions.
- Monitor and analyze quality metrics, identifying areas for improvement and implementing solutions.
- Ensure the quality and integrity of raw materials, in-process materials, and finished products.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality throughout the lifecycle.
- Stay current with evolving pharmaceutical regulations and industry best practices.
- Lead and mentor the QA team, fostering a culture of quality and compliance.
- Contribute to strategic decisions regarding quality policy and objectives.
- Master's or Ph.D. in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 7-10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- Extensive knowledge of GMP, GxP, ICH guidelines, and FDA/EMA regulations.
- Proven experience in developing and managing QMS.
- Demonstrated success in leading audits and managing regulatory inspections.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent leadership, communication, and interpersonal abilities.
- Experience working in a remote leadership role is essential.
- Proficiency in quality management software and tools.
- Ability to travel occasionally for essential site visits if required, though the role is primarily remote.
- While the role is remote, understanding the pharmaceutical landscape in the Kericho, Kericho, KE region can be beneficial.
This advertiser has chosen not to accept applicants from your region.
1
Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a rapidly growing biopharmaceutical company committed to developing life-changing therapies, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to lead our quality systems from a fully remote position. This is an exciting opportunity to make a significant impact on drug development and manufacturing quality from anywhere.
The Senior Pharmaceutical Quality Assurance Manager will be responsible for overseeing and improving the company's Quality Management System (QMS) to ensure compliance with global regulatory standards, including FDA, EMA, and ICH guidelines. You will manage quality audits, both internal and external, and ensure timely closure of findings. This role involves leading the QA team, providing strategic direction, and fostering a culture of quality excellence. Responsibilities include developing and implementing quality policies, procedures, and work instructions. You will also play a key role in regulatory submissions and inspections, ensuring all documentation is accurate and complete. The ability to effectively manage and mentor a remote QA team, ensuring seamless operation and communication, is critical.
Key responsibilities include:
Candidates should possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field. A minimum of 8 years of progressive experience in pharmaceutical Quality Assurance is required, with at least 3 years in a management or supervisory role. Strong knowledge of cGMP regulations, validation principles, and regulatory affairs is essential. Excellent leadership, communication, and problem-solving skills are crucial for this remote leadership position. The ability to build strong relationships and drive quality initiatives across a distributed organization is highly valued.
The Senior Pharmaceutical Quality Assurance Manager will be responsible for overseeing and improving the company's Quality Management System (QMS) to ensure compliance with global regulatory standards, including FDA, EMA, and ICH guidelines. You will manage quality audits, both internal and external, and ensure timely closure of findings. This role involves leading the QA team, providing strategic direction, and fostering a culture of quality excellence. Responsibilities include developing and implementing quality policies, procedures, and work instructions. You will also play a key role in regulatory submissions and inspections, ensuring all documentation is accurate and complete. The ability to effectively manage and mentor a remote QA team, ensuring seamless operation and communication, is critical.
Key responsibilities include:
- Developing, implementing, and maintaining the company's comprehensive Quality Management System (QMS).
- Leading and conducting internal and external (vendor) quality audits to ensure compliance.
- Managing regulatory inspections and ensuring successful outcomes.
- Reviewing and approving batch records, validation protocols, and other critical quality documents.
- Investigating deviations, CAPAs, and Out-of-Specification (OOS) results, implementing effective corrective and preventive actions.
- Ensuring adherence to cGMP principles throughout the product lifecycle.
- Providing QA oversight for product development, manufacturing, and release activities.
- Developing and delivering quality training programs to relevant personnel.
- Managing and mentoring a team of QA professionals in a remote environment.
- Staying current with evolving regulatory requirements and industry best practices.
Candidates should possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field. A minimum of 8 years of progressive experience in pharmaceutical Quality Assurance is required, with at least 3 years in a management or supervisory role. Strong knowledge of cGMP regulations, validation principles, and regulatory affairs is essential. Excellent leadership, communication, and problem-solving skills are crucial for this remote leadership position. The ability to build strong relationships and drive quality initiatives across a distributed organization is highly valued.
This advertiser has chosen not to accept applicants from your region.
2
Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a leading innovator in the pharmaceutical sector, is seeking a highly qualified Senior Pharmaceutical Quality Assurance Manager to lead their quality operations. This role is entirely remote, allowing you to contribute your expertise from anywhere. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) in compliance with global regulatory standards, including FDA, EMA, and local Kenyan regulations. Your duties will encompass overseeing all aspects of quality assurance, including batch record review, deviation management, CAPA (Corrective and Preventive Actions) implementation, change control, and internal/external audits. You will play a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical products throughout their lifecycle. This position requires a thorough understanding of GMP (Good Manufacturing Practices) and relevant pharmaceutical guidelines. The Senior QA Manager will lead a team of QA professionals, providing guidance, training, and mentorship. You will collaborate with R&D, manufacturing, and regulatory affairs departments to ensure quality is integrated into every stage of product development and production. Responsibilities also include preparing for and participating in regulatory inspections, as well as managing and resolving quality-related issues. The ideal candidate will possess a 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, with at least 3 years in a management role, is required. Strong analytical and problem-solving skills, excellent attention to detail, and exceptional leadership and communication abilities are essential. Experience with electronic QMS is highly desirable. You must be a self-starter, capable of working independently and driving results in a remote setting. This is an exceptional opportunity to make a significant impact on product quality and patient safety within a forward-thinking pharmaceutical organization. Embrace the benefits of remote work while leading critical quality initiatives in a highly regulated industry. Your contribution will be vital to maintaining our client's reputation for excellence.
This advertiser has chosen not to accept applicants from your region.
3
Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking an accomplished Senior Pharmaceutical Quality Assurance Manager to oversee their quality systems. This is a fully remote position, enabling you to lead quality assurance initiatives from any location. You will be responsible for developing, implementing, and maintaining robust quality assurance programs to ensure compliance with cGMP regulations, FDA guidelines, and other relevant international standards. Your core duties will include conducting internal audits, managing external audits, overseeing deviation and CAPA systems, reviewing batch records, and ensuring that all pharmaceutical products meet stringent quality and safety requirements. The ideal candidate will possess a strong background in pharmaceutical sciences, chemistry, or a related field, with extensive experience in quality assurance within the pharmaceutical industry. Proven leadership skills, a deep understanding of quality management systems (QMS), and experience with regulatory inspections are essential. You must possess excellent analytical and problem-solving abilities, with a meticulous attention to detail. Strong communication and interpersonal skills are required to effectively collaborate with cross-functional teams and regulatory bodies. This role offers a significant opportunity to drive quality excellence and ensure the integrity of pharmaceutical manufacturing processes. You will play a crucial role in safeguarding public health by ensuring the highest standards of product quality. We are looking for a proactive and detail-oriented leader committed to continuous improvement and compliance. The ability to interpret and apply complex regulatory requirements and guide teams toward achieving quality objectives will be highly valued. This is a key leadership role within the pharmaceutical sector, supporting operations from a remote perspective, with a focus on impacting the Ruiru, Kiambu, KE area. Your expertise will be instrumental in maintaining the company's reputation for quality and safety.
This advertiser has chosen not to accept applicants from your region.
4
Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client is seeking a highly qualified and detail-oriented Senior Pharmaceutical Quality Assurance Manager to lead their quality systems. This is a fully remote position, offering the opportunity to contribute significantly to a leading pharmaceutical company from the convenience of your home office. You will be responsible for developing, implementing, and maintaining robust quality assurance programs to ensure compliance with global regulatory standards, including FDA, EMA, and ICH guidelines. Your core duties will involve overseeing the quality control of manufacturing processes, product release, and the management of deviations, CAPAs, and change controls. You will also play a key role in internal and external audits, ensuring readiness and successful outcomes. This role requires extensive experience in pharmaceutical quality systems, risk management, and regulatory affairs. You will lead cross-functional teams, provide training on quality procedures, and champion a culture of quality throughout the organization. The ability to interpret complex regulations and translate them into practical operational procedures is essential. Experience with GMP (Good Manufacturing Practices) is mandatory. You will be involved in the validation of manufacturing processes, equipment, and analytical methods. Strong analytical and problem-solving skills are crucial for investigating quality issues and implementing effective corrective and preventive actions. Excellent written and verbal communication skills are necessary for documentation, reporting, and interacting with regulatory bodies. Our client values integrity, innovation, and a commitment to patient safety, and this role is central to upholding these values.
Responsibilities:
Qualifications:
Responsibilities:
- Develop, implement, and maintain pharmaceutical quality assurance systems.
- Ensure compliance with global regulatory requirements (FDA, EMA, ICH, etc.).
- Oversee GMP compliance in manufacturing and laboratory operations.
- Manage deviations, CAPAs, change controls, and batch record reviews.
- Lead and participate in internal and external audits.
- Conduct risk assessments and implement mitigation strategies.
- Validate manufacturing processes, equipment, and analytical methods.
- Provide training and guidance on quality procedures and best practices.
- Investigate quality issues and implement corrective and preventive actions.
- Author and review quality-related documents and reports.
Qualifications:
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 10 years of experience in pharmaceutical quality assurance and quality control.
- In-depth knowledge of GMP, GDP, and regulatory guidelines.
- Proven experience in managing quality systems, audits, and regulatory inspections.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent written and verbal communication skills.
- Ability to lead and motivate cross-functional teams remotely.
- Experience with validation processes and documentation.
- Familiarity with the Nyeri pharmaceutical landscape is a plus.
This advertiser has chosen not to accept applicants from your region.
5
Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a leading innovator in the pharmaceutical industry, is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to ensure the highest standards of quality and compliance across all operations. This critical remote role will oversee the implementation and maintenance of robust quality management systems, ensuring adherence to regulatory requirements, Good Manufacturing Practices (GMP), and internal quality policies. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality control, with a proven ability to lead and mentor QA teams. You will play a vital part in safeguarding product integrity and patient safety, working collaboratively with cross-functional teams in a fully remote setting.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with global regulatory standards (e.g., FDA, EMA, WHO).
- Oversee all aspects of Quality Assurance, including batch record review, deviation management, CAPA (Corrective and Preventive Actions), change control, and validation activities.
- Conduct internal audits and support external regulatory inspections, ensuring readiness and compliance.
- Review and approve quality-related documents, including Standard Operating Procedures (SOPs), specifications, and validation protocols.
- Lead and mentor the Quality Assurance team, fostering a culture of quality excellence and continuous improvement.
- Manage the investigation of product quality complaints and non-conformances, implementing effective corrective actions.
- Ensure compliance with relevant GxP regulations (GMP, GLP, GCP) throughout the product lifecycle.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure quality is integrated into all stages of product development and commercialization.
- Monitor key quality metrics and provide regular reports to senior management on the status of the QMS and compliance.
- Stay current with evolving pharmaceutical regulations and industry best practices.
- Participate in supplier qualification and quality agreements.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Senior pharmaceutical quality assurance manager Jobs in Kenya !
6
Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a dynamic pharmaceutical company, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to ensure the highest standards of product quality and regulatory compliance. This is a fully remote position, offering the flexibility to contribute your expertise from any location. The manager will be responsible for developing, implementing, and maintaining comprehensive quality management systems across all pharmaceutical operations. You will play a critical role in ensuring adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines. Key responsibilities include conducting internal audits, managing external audits, overseeing deviation investigations, and implementing corrective and preventive actions (CAPA). The ideal candidate will possess a strong background in pharmaceutical sciences or a related field, coupled with extensive experience in quality assurance and regulatory affairs. Thorough knowledge of FDA, EMA, and other international regulatory requirements is essential. You will collaborate closely with R&D, manufacturing, and supply chain teams to foster a robust quality culture. We are looking for a detail-oriented and proactive leader with excellent analytical and problem-solving skills. This is an exceptional opportunity to make a significant contribution to patient safety and product integrity within the pharmaceutical industry, supporting quality initiatives relevant to **Garissa, Garissa, KE**. The role demands strong leadership capabilities, effective communication skills, and the ability to manage quality assurance programs and teams remotely.
This advertiser has chosen not to accept applicants from your region.
7
Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client is seeking a highly accomplished and detail-oriented Senior Pharmaceutical Quality Assurance Manager to lead their quality systems and compliance efforts. This crucial role, operating remotely, is responsible for ensuring that all pharmaceutical products manufactured meet stringent quality standards, regulatory requirements, and customer expectations. You will oversee the development, implementation, and maintenance of a robust Quality Management System (QMS), encompassing all aspects from raw material sourcing to finished product release. Your responsibilities include developing and executing quality control strategies, conducting internal and external audits, managing deviations and CAPAs, and ensuring compliance with Good Manufacturing Practices (GMP) and other relevant pharmaceutical regulations. You will lead a remote team of QA professionals, providing guidance, mentorship, and fostering a culture of quality excellence. Collaboration with R&D, manufacturing, regulatory affairs, and supply chain departments – conducted virtually – is paramount to ensuring product integrity throughout the lifecycle. The ideal candidate will possess extensive knowledge of the pharmaceutical industry, quality assurance principles, and regulatory landscapes (e.g., FDA, EMA). Exceptional analytical, problem-solving, and leadership skills are essential. You will be responsible for staying abreast of evolving regulatory requirements and implementing necessary changes to maintain compliance. This fully remote position allows you to contribute your expertise to our operations supporting the **Kakamega, Kakamega, KE** region, ensuring the highest standards of pharmaceutical quality and patient safety from your home office.
Responsibilities:
Qualifications:
Responsibilities:
- Develop, implement, and manage the Quality Management System (QMS).
- Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory standards.
- Oversee quality control processes and product release.
- Conduct internal and external audits of suppliers and manufacturing sites.
- Manage deviations, investigations, and Corrective and Preventive Actions (CAPAs).
- Lead and mentor the Quality Assurance team.
- Collaborate with cross-functional departments on quality-related matters.
- Review and approve batch records, validation protocols, and technical documents.
- Stay current with pharmaceutical regulations and industry best practices.
- Drive continuous improvement initiatives within the QA function.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 9 years of progressive experience in pharmaceutical Quality Assurance.
- Proven experience managing a QA department and leading teams.
- In-depth knowledge of GMP, ICH guidelines, and other relevant pharmaceutical regulations.
- Strong understanding of quality risk management principles.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication abilities.
- Experience working remotely and managing distributed teams is highly desirable.
- Strong leadership and interpersonal skills.
This advertiser has chosen not to accept applicants from your region.
8
Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to lead and enhance their quality systems. This role offers a hybrid work model, combining remote flexibility with essential on-site presence for critical oversight and collaboration. You will be responsible for developing, implementing, and maintaining robust quality assurance programs that ensure compliance with regulatory requirements (e.g., cGMP, ICH guidelines) and internal standards throughout the pharmaceutical product lifecycle. Your duties will include overseeing quality control processes, managing batch record reviews, investigating deviations and out-of-specification results, and implementing CAPAs (Corrective and Preventive Actions). You will lead and mentor a team of QA professionals, fostering a culture of quality excellence and continuous improvement. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, quality risk management, and regulatory affairs. Strong leadership, excellent analytical, and exceptional communication skills are essential for driving quality initiatives and collaborating with various departments, including R&D, manufacturing, and regulatory affairs. This position offers a significant opportunity to ensure the integrity, safety, and efficacy of pharmaceutical products and contribute to the company's reputation for quality. You will be instrumental in maintaining compliance, preventing quality issues, and driving operational excellence in a complex regulatory environment. The ability to interpret complex regulations, conduct internal audits, and lead external audits is critical. You will also play a key role in the qualification and validation of equipment and processes. Continuous learning and staying abreast of evolving regulatory expectations are paramount. This role demands a strategic thinker with a passion for quality and a commitment to upholding the highest standards in the pharmaceutical industry. The operational focus is **Malindi, Kilifi, KE**, and the role requires a hybrid working arrangement.
Key Responsibilities:
Key Responsibilities:
- Develop and implement comprehensive Quality Assurance programs and SOPs.
- Ensure compliance with cGMP, ICH guidelines, and other relevant regulations.
- Oversee batch record review and release processes.
- Lead investigations of deviations, OOS results, and customer complaints.
- Develop and manage Corrective and Preventive Actions (CAPAs).
- Conduct internal audits and support external regulatory inspections.
- Manage and mentor the QA team, fostering a strong quality culture.
- Participate in process validation and equipment qualification activities.
- Collaborate with R&D, manufacturing, and regulatory affairs departments.
- Contribute to quality risk management initiatives.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Master's degree or relevant advanced qualification is highly preferred.
- Minimum of 7 years of experience in pharmaceutical Quality Assurance or Quality Control.
- Proven experience in developing and implementing QA systems in a cGMP environment.
- In-depth knowledge of pharmaceutical regulatory requirements (e.g., FDA, EMA, ICH).
- Experience with batch record review, deviation management, and CAPA systems.
- Strong understanding of quality risk management principles.
- Excellent leadership, analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills.
- Ability to work effectively in a hybrid work model.
- Relevant certifications (e.g., CQMgr) are a plus.
This advertiser has chosen not to accept applicants from your region.
9