17 Remote Senior Pharmaceutical Quality Assurance Manager jobs in whatjobs
Remote Senior Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a rapidly growing pharmaceutical company, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to lead their quality operations. This is a fully remote position, offering a unique opportunity to shape quality systems from anywhere. You will be responsible for ensuring that all pharmaceutical products manufactured and distributed by our client meet stringent quality standards, regulatory requirements, and company specifications. This role requires a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant global pharmaceutical regulations.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) for pharmaceutical products.
- Oversee and manage all aspects of Quality Assurance (QA) and Quality Control (QC) activities.
- Ensure compliance with global regulatory requirements, including FDA, EMA, and local Kenyan regulations.
- Lead and participate in internal and external audits (regulatory bodies, suppliers, partners).
- Manage deviation investigations, CAPA (Corrective and Preventive Actions), and change control processes.
- Review and approve batch records, validation protocols, and other critical quality documentation.
- Develop and deliver QA training programs to relevant personnel.
- Monitor quality metrics and KPIs, and report on quality performance to senior management.
- Oversee supplier qualification and auditing processes.
- Stay current with pharmaceutical industry trends, regulatory updates, and best practices in quality assurance.
- Manage and mentor the QA team.
- Contribute to product development and lifecycle management from a quality perspective.
- Ensure the quality and integrity of raw materials, in-process materials, and finished products.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 8 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP, GLP, GCP, and other relevant pharmaceutical quality standards.
- Proven experience in developing and implementing QMS in a pharmaceutical setting.
- Strong understanding of regulatory submission processes and requirements.
- Experience with audits, investigations, CAPA, and change control systems.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional leadership, team management, and interpersonal skills.
- Strong written and verbal communication skills, with the ability to articulate complex quality issues clearly.
- Proficiency in quality management software and tools.
- Ability to work independently and manage responsibilities effectively in a remote environment.
- Experience with sterile manufacturing or biologics is a plus.
This advertiser has chosen not to accept applicants from your region.
0
Remote Senior Pharmaceutical Quality Assurance Manager
Posted 13 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager for a fully remote position. This role is critical for upholding the highest standards of quality and compliance throughout the pharmaceutical lifecycle, from development to post-market surveillance. The successful candidate will lead quality initiatives, ensure adherence to Good Manufacturing Practices (GMP) and other relevant regulations, and drive continuous improvement within the quality management system. Although remote, occasional site visits, including to facilities near **Naivasha, Nakuru, KE**, may be required.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain a robust Quality Management System (QMS) compliant with global pharmaceutical regulations (e.g., FDA, EMA, WHO GMP).
- Oversee all aspects of Quality Assurance (QA) operations, including batch record review, deviation management, change control, CAPA implementation, and complaint handling.
- Conduct internal audits and support external regulatory inspections and client audits.
- Ensure that all pharmaceutical products meet established quality and safety standards.
- Lead and mentor the QA team, fostering a culture of quality excellence and compliance.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure seamless product lifecycle management.
- Review and approve validation protocols and reports for manufacturing processes, equipment, and analytical methods.
- Manage supplier qualification programs and ensure the quality of raw materials and components.
- Stay current with evolving pharmaceutical regulations, guidelines, and industry best practices.
- Drive continuous improvement initiatives to enhance product quality, operational efficiency, and compliance.
- Prepare and present quality metrics and reports to senior management.
- Master's or Ph.D. degree in Pharmacy, Chemistry, Biotechnology, or a related life sciences field.
- Minimum of 10 years of progressive experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
- Extensive knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in managing QMS, conducting audits, and leading regulatory inspections.
- Strong understanding of pharmaceutical manufacturing processes, drug development, and analytical testing.
- Excellent leadership, team management, and interpersonal skills.
- Exceptional analytical and problem-solving abilities, with a high level of attention to detail.
- Outstanding written and verbal communication skills, capable of effectively communicating complex quality concepts.
- Experience with electronic QMS and document management systems is highly desirable.
- Ability to work independently and manage priorities effectively in a remote setting.
- Willingness to travel occasionally for critical quality assessments and audits.
This advertiser has chosen not to accept applicants from your region.
1
Remote Senior Pharmaceutical Quality Assurance Manager
Posted 15 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to join their fully remote, high-performing team. This crucial role is responsible for ensuring the highest standards of quality and compliance across all pharmaceutical manufacturing and development processes. You will lead the development, implementation, and maintenance of robust Quality Management Systems (QMS) in accordance with national and international regulatory guidelines (e.g., GMP, ICH). Key responsibilities include conducting internal and external audits, managing deviation investigations, implementing CAPA (Corrective and Preventive Actions) plans, and overseeing batch record reviews. You will also play a key role in regulatory submissions and inspections, acting as a subject matter expert. This remote position requires strong leadership, excellent communication skills for virtual collaboration with cross-functional teams (R&D, Manufacturing, Regulatory Affairs), and the ability to drive continuous improvement initiatives. A deep understanding of pharmaceutical manufacturing processes, quality control principles, and regulatory affairs is mandatory. The ideal candidate will hold a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field, with a minimum of 8 years of experience in pharmaceutical quality assurance and quality control. Proven experience in leading QA teams and managing complex quality systems is essential. Join a company committed to advancing healthcare through quality and innovation, offering a challenging and rewarding remote career opportunity supporting operations connected to **Nakuru, Nakuru, KE**.
This advertiser has chosen not to accept applicants from your region.
2
Remote Senior Pharmaceutical Quality Assurance Manager
Posted 11 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical company dedicated to improving health outcomes, is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to join their fully remote team. This pivotal role will be instrumental in ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, in strict adherence to regulatory requirements. You will be responsible for developing, implementing, and maintaining comprehensive quality management systems (QMS) across all stages of the product lifecycle, from research and development to manufacturing and distribution. This includes overseeing compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant international guidelines.
Key Responsibilities:
The ideal candidate will hold 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 and quality control is required, with at least 3 years in a management or supervisory role. Proven expertise in GMP, ICH guidelines, and regulatory affairs is essential. Demonstrated experience in managing QMS, conducting audits, and leading investigations is mandatory. Excellent analytical, problem-solving, and decision-making skills are critical. Strong written and verbal communication skills are necessary to effectively interact with internal teams and external regulatory bodies. Experience with electronic QMS (eQMS) systems is highly desirable. This remote position offers the flexibility to work from anywhere, while contributing significantly to the development and delivery of safe and effective medicines worldwide. A commitment to quality and patient safety is paramount.
Key Responsibilities:
- Develop, implement, and manage the company's Quality Management System (QMS) to ensure compliance with global regulatory standards (e.g., FDA, EMA, WHO).
- Oversee and conduct internal and external audits of manufacturing facilities, suppliers, and contract manufacturers.
- Review and approve critical quality documents, including batch records, validation protocols, and standard operating procedures (SOPs).
- Lead investigations into quality deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Ensure the proper qualification and validation of equipment, processes, and analytical methods.
- Stay current with evolving regulatory requirements and industry best practices, and advise the organization accordingly.
- Manage product quality reviews and trend analysis, identifying areas for continuous improvement.
- Train and mentor quality assurance personnel.
- Collaborate with R&D, manufacturing, regulatory affairs, and other departments to ensure a seamless transition of products from development to commercialization.
- Prepare for and support regulatory inspections and agency audits.
The ideal candidate will hold 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 and quality control is required, with at least 3 years in a management or supervisory role. Proven expertise in GMP, ICH guidelines, and regulatory affairs is essential. Demonstrated experience in managing QMS, conducting audits, and leading investigations is mandatory. Excellent analytical, problem-solving, and decision-making skills are critical. Strong written and verbal communication skills are necessary to effectively interact with internal teams and external regulatory bodies. Experience with electronic QMS (eQMS) systems is highly desirable. This remote position offers the flexibility to work from anywhere, while contributing significantly to the development and delivery of safe and effective medicines worldwide. A commitment to quality and patient safety is paramount.
This advertiser has chosen not to accept applicants from your region.
3
Remote Senior Pharmaceutical Quality Assurance Manager
Posted 11 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is looking for a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to ensure the highest standards of product quality and regulatory compliance. This is a fully remote position, allowing you to lead quality assurance efforts from anywhere while contributing to the development and manufacturing of life-saving medicines. You will be responsible for developing, implementing, and maintaining a robust quality management system (QMS) in adherence to global regulatory requirements (e.g., GMP, ICH guidelines). Your role will involve overseeing quality control processes, conducting internal audits, managing deviations and CAPAs (Corrective and Preventive Actions), and ensuring compliance with all relevant pharmaceutical regulations. You will also play a key role in supplier qualification, batch record review, and the investigation of quality-related issues. The ideal candidate will have a strong scientific background, with extensive experience in the pharmaceutical industry. Excellent understanding of quality assurance principles, regulatory affairs, and Good Manufacturing Practices (GMP) is critical. You must possess strong analytical, problem-solving, and decision-making skills, with the ability to lead and mentor a remote QA team effectively. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field is required, along with a minimum of 10 years of progressive experience in pharmaceutical quality assurance, with at least 5 years in a management or leadership role. Experience with electronic QMS (eQMS) and other relevant software is essential. This role offers a challenging and rewarding opportunity to contribute to the safety and efficacy of pharmaceutical products on a global scale. Join our dedicated team and help uphold our commitment to excellence in pharmaceutical manufacturing and quality.
This advertiser has chosen not to accept applicants from your region.
4
Remote Senior Pharmaceutical Quality Assurance Manager
Posted 11 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and meticulous Remote Senior Pharmaceutical Quality Assurance Manager to uphold and enhance the quality standards of their pharmaceutical products and operations. This is a fully remote position, requiring a dedicated professional with a comprehensive understanding of pharmaceutical regulations, quality management systems (QMS), and GMP (Good Manufacturing Practices). You will be responsible for developing, implementing, and maintaining robust quality assurance protocols and procedures to ensure compliance and product integrity.
Key responsibilities include overseeing all aspects of the QMS, ensuring adherence to regulatory requirements such as FDA, EMA, and local health authority standards. You will lead internal and external audits, manage deviation investigations, and implement corrective and preventive actions (CAPA). This role requires the ability to develop and deliver training programs on quality standards and regulatory compliance to remote teams. You will review and approve critical quality documents, including batch records, validation protocols, and SOPs. The successful candidate will play a key role in continuous improvement initiatives aimed at enhancing product quality and operational efficiency. Strong analytical skills are needed to identify quality trends, assess risks, and develop mitigation strategies. Excellent communication and interpersonal skills are essential for collaborating effectively with cross-functional teams, regulatory bodies, and external partners. The ability to work autonomously, manage multiple priorities, and maintain a high level of accuracy in a remote setting is crucial. A deep understanding of pharmaceutical manufacturing processes and lifecycle management is highly desirable. This is a significant opportunity to contribute to the safety and efficacy of pharmaceutical products, driving quality excellence from a remote work setup, supporting operations relevant to the region of Kisumu, Kisumu, KE .
Key responsibilities include overseeing all aspects of the QMS, ensuring adherence to regulatory requirements such as FDA, EMA, and local health authority standards. You will lead internal and external audits, manage deviation investigations, and implement corrective and preventive actions (CAPA). This role requires the ability to develop and deliver training programs on quality standards and regulatory compliance to remote teams. You will review and approve critical quality documents, including batch records, validation protocols, and SOPs. The successful candidate will play a key role in continuous improvement initiatives aimed at enhancing product quality and operational efficiency. Strong analytical skills are needed to identify quality trends, assess risks, and develop mitigation strategies. Excellent communication and interpersonal skills are essential for collaborating effectively with cross-functional teams, regulatory bodies, and external partners. The ability to work autonomously, manage multiple priorities, and maintain a high level of accuracy in a remote setting is crucial. A deep understanding of pharmaceutical manufacturing processes and lifecycle management is highly desirable. This is a significant opportunity to contribute to the safety and efficacy of pharmaceutical products, driving quality excellence from a remote work setup, supporting operations relevant to the region of Kisumu, Kisumu, KE .
This advertiser has chosen not to accept applicants from your region.
5
Remote Senior Pharmaceutical Quality Assurance Manager
Posted 11 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and detail-oriented Senior Pharmaceutical Quality Assurance Manager to oversee their quality systems and compliance initiatives. This is a critical, fully remote position that requires a deep understanding of pharmaceutical manufacturing, regulatory affairs, and quality management principles. The ideal candidate will be adept at developing, implementing, and maintaining robust QA programs to ensure product safety, efficacy, and adherence to global regulatory standards, including GMP, GLP, and GCP.
Key responsibilities include:
The successful candidate will possess exceptional analytical and problem-solving skills, with a meticulous attention to detail. Strong leadership, communication, and interpersonal skills are essential for effectively managing cross-functional teams and interacting with regulatory bodies. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field is mandatory. A Master's degree or PharmD is highly preferred. A minimum of 7 years of progressive experience in pharmaceutical Quality Assurance is required, with at least 3 years in a management or supervisory role. Experience with sterile manufacturing and biologics is a significant advantage. This position is fully remote, offering a unique opportunity to contribute to pharmaceutical quality from any location. The administrative hub is in Kisumu, Kisumu, KE , but the role is location-independent.
Key responsibilities include:
- Developing, implementing, and managing comprehensive Quality Assurance and Quality Control (QA/QC) programs.
- Ensuring all pharmaceutical products meet stringent quality standards and regulatory requirements (e.g., FDA, EMA, WHO).
- Conducting internal and external audits of manufacturing facilities, suppliers, and contract manufacturers.
- Reviewing and approving batch records, validation protocols, and deviation reports.
- Managing the CAPA (Corrective and Preventive Actions) system to address quality issues and prevent recurrence.
- Developing and delivering training programs on quality systems and regulatory compliance for relevant personnel.
- Leading regulatory inspections and ensuring prompt and effective responses to inquiries.
- Collaborating with R&D, manufacturing, and regulatory affairs departments to ensure seamless product lifecycle management.
- Staying current with evolving pharmaceutical regulations and industry best practices.
- Preparing and presenting quality metrics and reports to senior management.
The successful candidate will possess exceptional analytical and problem-solving skills, with a meticulous attention to detail. Strong leadership, communication, and interpersonal skills are essential for effectively managing cross-functional teams and interacting with regulatory bodies. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field is mandatory. A Master's degree or PharmD is highly preferred. A minimum of 7 years of progressive experience in pharmaceutical Quality Assurance is required, with at least 3 years in a management or supervisory role. Experience with sterile manufacturing and biologics is a significant advantage. This position is fully remote, offering a unique opportunity to contribute to pharmaceutical quality from any location. The administrative hub is in Kisumu, Kisumu, KE , but the role is location-independent.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Remote senior pharmaceutical quality assurance manager Jobs in Kenya !
6
Remote Senior Pharmaceutical Quality Assurance Manager
Posted 10 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to join their established fully remote team. This critical role ensures that all pharmaceutical products meet stringent quality standards and comply with regulatory requirements. You will be responsible for developing, implementing, and maintaining the Quality Management System (QMS), overseeing quality control processes, and conducting internal audits. The ideal candidate will have a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant global pharmaceutical regulations. You will lead quality initiatives, mentor junior QA personnel, and serve as a key point of contact for regulatory inspections. This position demands exceptional attention to detail, strong leadership capabilities, and the ability to effectively manage quality assurance activities in a remote work environment.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) to ensure compliance with global pharmaceutical standards.
- Oversee all aspects of quality control and quality assurance for pharmaceutical manufacturing processes.
- Conduct internal audits and inspections of manufacturing sites, laboratories, and distribution channels.
- Review and approve batch records, validation protocols, and deviation reports.
- Manage change control processes and ensure all changes are adequately assessed and documented.
- Investigate quality incidents, deviations, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Ensure compliance with GMP, GLP, GCP, and relevant international regulatory guidelines (e.g., FDA, EMA, WHO).
- Prepare for and participate in external regulatory inspections and audits.
- Train and mentor QA team members on quality principles and regulatory requirements.
- Contribute to the development and improvement of SOPs, policies, and procedures.
- Stay updated on emerging trends and regulations in the pharmaceutical quality assurance field.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 8 years of progressive experience in pharmaceutical Quality Assurance and Quality Control.
- In-depth knowledge of GMP, GLP, and regulatory requirements for pharmaceutical products.
- Proven experience in developing and managing a robust QMS.
- Demonstrated ability to lead audits and regulatory inspections.
- Excellent understanding of pharmaceutical manufacturing processes and analytical testing.
- Strong leadership, communication, and interpersonal skills.
- Ability to work independently, manage time effectively, and maintain high standards in a remote setting.
- Experience with data integrity principles and electronic record-keeping systems.
- Problem-solving and risk assessment skills are essential.
This advertiser has chosen not to accept applicants from your region.
7
Remote Senior Pharmaceutical Quality Assurance Manager
Posted 16 days ago
Job Viewed
Job Description
Our client, a growing pharmaceutical company, is looking for a highly qualified Senior Pharmaceutical Quality Assurance Manager to lead their quality assurance efforts in a fully remote capacity. This critical role will ensure that all products meet stringent quality standards and comply with regulatory requirements, including GMP (Good Manufacturing Practices). The successful candidate will be responsible for developing, implementing, and maintaining robust quality management systems. This includes overseeing batch record reviews, deviation investigations, CAPA (Corrective and Preventive Actions) management, and change control processes. You will also conduct internal audits, support regulatory inspections, and train personnel on quality assurance procedures. The ideal candidate will possess a strong background in pharmaceutical sciences or a related field, with a comprehensive understanding of regulatory frameworks governing the pharmaceutical industry. Exceptional analytical skills, meticulous attention to detail, and excellent problem-solving abilities are essential. This is a remote-first position, requiring strong self-discipline, organizational skills, and the ability to effectively manage a quality assurance program without direct on-site supervision. You will collaborate closely with R&D, manufacturing, and regulatory affairs departments to ensure product quality and compliance throughout the product lifecycle. This role offers a unique opportunity to make a significant impact on patient safety and product efficacy by upholding the highest standards of pharmaceutical quality.This is a fully remote position.
This advertiser has chosen not to accept applicants from your region.
8
Remote Senior Pharmaceutical Quality Assurance Manager
Posted 7 days ago
Job Viewed
Job Description
Our client is seeking a highly qualified Senior Pharmaceutical Quality Assurance Manager to lead quality initiatives within a fully remote setting. This critical role ensures that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be responsible for developing, implementing, and maintaining comprehensive quality management systems (QMS), including standard operating procedures (SOPs), batch record reviews, and deviation investigations. Key duties involve overseeing quality control processes, conducting internal audits, managing regulatory inspections, and driving continuous improvement in quality metrics. Experience with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines is essential. The ideal candidate will possess strong analytical, problem-solving, and leadership skills, with a proven ability to manage complex quality assurance operations. Excellent communication and interpersonal skills are required for effective collaboration with cross-functional teams, regulatory agencies, and external partners in a remote environment. You must be detail-oriented, proactive, and committed to upholding the highest standards of pharmaceutical quality and compliance.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS).
- Oversee all quality assurance activities, including batch record review and release.
- Ensure compliance with GMP, GDP, and other relevant pharmaceutical regulations.
- Conduct internal audits and support external regulatory inspections.
- Manage deviations, CAPAs (Corrective and Preventive Actions), and change controls.
- Review and approve validation protocols and reports.
- Train and mentor QA personnel and other staff on quality procedures.
- Collaborate with R&D, manufacturing, and regulatory affairs teams.
- Monitor quality metrics and drive continuous improvement initiatives.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related science field.
- 5+ years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GMP, GLP, and regulatory requirements (FDA, EMA, etc.).
- Experience with QMS, SOP development, audits, and investigations.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent leadership, communication, and interpersonal abilities.
- Proficiency in relevant software and quality management tools.
- Ability to manage projects and work effectively in a remote team environment.
This advertiser has chosen not to accept applicants from your region.
9