12 Senior Pharmaceutical Quality Assurance Manager Remote jobs in whatjobs
Senior Pharmaceutical Quality Assurance Manager
Posted 19 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and experienced Senior Pharmaceutical Quality Assurance Manager to lead quality initiatives within their dynamic organization. This is a fully remote position, requiring a deep understanding of pharmaceutical manufacturing, regulatory compliance, and quality management systems. You will be responsible for ensuring that all products meet the highest standards of quality, safety, and efficacy, adhering strictly to Good Manufacturing Practices (GMP) and relevant international regulatory guidelines. Key responsibilities include developing and implementing QA policies and procedures, overseeing internal and external audits, managing deviation investigations, and driving corrective and preventive actions (CAPA). The ideal candidate will have a proven track record in pharmaceutical quality assurance, with expertise in quality risk management and validation processes. Experience with regulatory submissions and inspections is highly desirable. This role is remote-first, demanding exceptional organizational skills, strong analytical abilities, and the capacity to manage a distributed team effectively through virtual collaboration. You will work closely with research and development, manufacturing, and regulatory affairs departments to ensure seamless integration of quality standards across all operations. We are looking for a proactive leader with excellent communication and interpersonal skills, capable of fostering a strong quality culture throughout the organization. A comprehensive knowledge of pharmacopeias (e.g., USP, EP, BP) is essential. Your expertise will be crucial in maintaining the integrity and reputation of our client's pharmaceutical offerings, with a focus on operations related to the Mombasa, Mombasa, KE region.
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Senior Pharmaceutical Quality Assurance Manager
Posted 19 days ago
Job Viewed
Job Description
Our client is looking for a highly accomplished and detail-oriented Senior Pharmaceutical Quality Assurance Manager to lead their quality systems remotely. This crucial role ensures compliance with all relevant regulatory standards and internal quality policies. You will be responsible for developing, implementing, and maintaining robust quality assurance programs throughout the pharmaceutical product lifecycle, from development to commercialization. This includes overseeing batch record reviews, deviation investigations, CAPA management, change control, and internal/external audits. Your expertise will be vital in ensuring the integrity and safety of pharmaceutical products.
Key responsibilities involve interpreting and applying Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines (e.g., FDA, EMA). You will lead and mentor a remote QA team, foster a culture of quality awareness, and drive continuous improvement initiatives. The ideal candidate will possess strong leadership skills, exceptional analytical and problem-solving abilities, and a comprehensive understanding of pharmaceutical manufacturing processes. Excellent communication and interpersonal skills are essential for collaborating effectively with cross-functional teams, regulatory agencies, and external partners. This is a fully remote position that requires a proactive approach to quality management and a commitment to upholding the highest standards of pharmaceutical quality.
We are seeking a candidate with a proven track record in pharmaceutical quality assurance, preferably with experience in various dosage forms. Experience in managing quality systems in a remote or distributed team environment is a significant advantage. You will play a key role in preparing for and participating in regulatory inspections and ensuring successful outcomes. The successful candidate will be instrumental in safeguarding product quality and patient safety while supporting the company's strategic objectives. Your ability to manage complex quality challenges, drive compliance, and promote a quality-centric mindset across the organization will be critical to your success in this vital remote role.
Key responsibilities involve interpreting and applying Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines (e.g., FDA, EMA). You will lead and mentor a remote QA team, foster a culture of quality awareness, and drive continuous improvement initiatives. The ideal candidate will possess strong leadership skills, exceptional analytical and problem-solving abilities, and a comprehensive understanding of pharmaceutical manufacturing processes. Excellent communication and interpersonal skills are essential for collaborating effectively with cross-functional teams, regulatory agencies, and external partners. This is a fully remote position that requires a proactive approach to quality management and a commitment to upholding the highest standards of pharmaceutical quality.
We are seeking a candidate with a proven track record in pharmaceutical quality assurance, preferably with experience in various dosage forms. Experience in managing quality systems in a remote or distributed team environment is a significant advantage. You will play a key role in preparing for and participating in regulatory inspections and ensuring successful outcomes. The successful candidate will be instrumental in safeguarding product quality and patient safety while supporting the company's strategic objectives. Your ability to manage complex quality challenges, drive compliance, and promote a quality-centric mindset across the organization will be critical to your success in this vital remote role.
This advertiser has chosen not to accept applicants from your region.
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Senior Pharmaceutical Quality Assurance Manager
Posted 19 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical entity, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to lead their remote QA operations. This critical role will ensure that all pharmaceutical products meet stringent quality standards, regulatory requirements, and company specifications. The ideal candidate will possess a deep understanding of Good Manufacturing Practices (GMP), Quality Management Systems (QMS), and regulatory compliance within the pharmaceutical industry. You will collaborate with a global team of scientists, production staff, and regulatory affairs professionals to uphold the highest levels of product quality and safety. This is a fully remote position, requiring exceptional attention to detail, strong leadership, and the ability to manage complex quality processes from a home office.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop, implement, and maintain a comprehensive Quality Management System (QMS) in compliance with global pharmaceutical regulations (e.g., FDA, EMA, WHO GMP).
- Oversee all aspects of pharmaceutical quality assurance, including batch record review, deviation management, change control, and CAPA (Corrective and Preventive Actions).
- Conduct internal audits and support external regulatory inspections to ensure compliance and identify areas for improvement.
- Review and approve validation protocols and reports for manufacturing processes, equipment, and analytical methods.
- Manage product quality reviews, stability programs, and complaint investigations.
- Provide leadership and guidance to the QA team, fostering a culture of quality excellence.
- Collaborate with R&D, Manufacturing, and Regulatory Affairs departments to ensure product quality throughout the lifecycle.
- Assess and qualify raw material suppliers and contract manufacturing organizations.
- Stay current with evolving regulatory guidelines, industry trends, and quality best practices.
- Participate in product development and scale-up activities, ensuring quality considerations are integrated from the outset.
- Prepare and present quality metrics and reports to senior management.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8-10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- Extensive knowledge of GMP, ICH guidelines, and regulatory submission processes.
- Proven experience in developing and managing QMS, conducting audits, and leading regulatory inspections.
- Strong understanding of pharmaceutical manufacturing processes, analytical testing, and validation principles.
- Excellent leadership, communication, interpersonal, and problem-solving skills.
- Demonstrated ability to manage teams and projects effectively in a remote setting.
- Proficiency in quality management software and tools.
- Detail-oriented with a strong commitment to scientific integrity and quality standards.
This advertiser has chosen not to accept applicants from your region.
2
Senior Pharmaceutical Quality Assurance Manager
Posted 19 days ago
Job Viewed
Job Description
Our client, a distinguished pharmaceutical company, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to lead their quality operations at their **Mombasa, Mombasa, KE** facility. This role is crucial for ensuring that all products meet the highest standards of quality, safety, and efficacy, adhering to stringent regulatory requirements such as Good Manufacturing Practices (GMP). You will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS), overseeing all QA activities including batch record review, deviation investigations, change control, CAPA management, and internal/external audits. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes and regulatory landscapes, including FDA, EMA, and local Kenyan regulations. This position requires strong leadership skills, meticulous attention to detail, and excellent problem-solving abilities. You will lead a team of QA professionals, fostering a culture of compliance and continuous improvement. Collaboration with production, R&D, and regulatory affairs departments is essential to ensure seamless integration and adherence to quality standards. Experience with validation activities (process, equipment, cleaning) is highly desirable. We are looking for a results-oriented individual who can drive quality excellence, mitigate risks, and ensure the integrity of our pharmaceutical products manufactured in **Mombasa, Mombasa, KE**. This role offers a challenging and rewarding opportunity to contribute significantly to patient safety and company success.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with GMP and other relevant regulations.
- Oversee all Quality Assurance activities, including batch record review and release.
- Manage and conduct internal and external audits (e.g., supplier audits, regulatory inspections).
- Lead and manage investigations for deviations, out-of-specification (OOS) results, and customer complaints.
- Develop and manage Corrective and Preventive Actions (CAPA) plans.
- Oversee change control processes and risk assessments.
- Ensure compliance with all applicable pharmaceutical regulations (e.g., FDA, EMA, Kenyan MOH).
- Lead, train, and mentor the Quality Assurance team.
- Collaborate with Production, R&D, and other departments to ensure product quality and compliance.
- Participate in validation activities (IQ, OQ, PQ) for equipment, processes, and cleaning.
- Review and approve critical quality documents, such as SOPs, validation protocols, and reports.
- Drive continuous improvement initiatives within the QA department and manufacturing operations.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. Master's degree preferred.
- Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of Good Manufacturing Practices (GMP) and other relevant pharmaceutical regulations.
- Proven experience in managing QMS, batch release, audits, deviations, and CAPA.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent leadership, communication, problem-solving, and interpersonal skills.
- Experience with validation activities is highly desirable.
- Ability to interpret and apply complex regulatory guidelines.
- Strong analytical skills and attention to detail.
This advertiser has chosen not to accept applicants from your region.
3
Senior Pharmaceutical Quality Assurance Manager
Posted 9 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to oversee and enhance their quality management systems. This hybrid role requires a strong leader with extensive knowledge of GMP (Good Manufacturing Practices), regulatory compliance, and quality control within the pharmaceutical industry. Based near **Mlolongo, Machakos, KE**, you will be instrumental in ensuring that all pharmaceutical products meet stringent quality standards and comply with local and international regulations. Your responsibilities will include developing, implementing, and maintaining quality assurance policies and procedures, conducting internal and external audits, and managing regulatory inspections. You will lead a team of quality assurance professionals, providing guidance, training, and performance management. The role involves close collaboration with manufacturing, R&D, and regulatory affairs departments to address quality issues, implement corrective and preventive actions (CAPA), and drive continuous improvement initiatives. A key part of your role will be to champion a quality-focused culture throughout the organization. While the role is hybrid, requiring your presence in the office for critical meetings and oversight approximately 2-3 days a week, flexibility is offered for remote work on other days, allowing for a better work-life balance. The ideal candidate will possess a strong scientific background, excellent leadership abilities, and a proven track record in pharmaceutical quality assurance. Expertise in risk management and validation processes is essential.
Responsibilities:
Qualifications:
Responsibilities:
- Develop, implement, and maintain robust Quality Management Systems (QMS) in compliance with pharmaceutical regulations.
- Oversee and execute internal audits, supplier audits, and ensure readiness for regulatory inspections.
- Lead the investigation of deviations, complaints, and out-of-specification results, and manage the CAPA system.
- Ensure compliance with all relevant regulatory requirements (e.g., KEBS, FDA, EMA).
- Manage and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement.
- Review and approve critical quality documents, including batch records, validation protocols, and SOPs.
- Collaborate with cross-functional teams to resolve quality issues and implement process improvements.
- Monitor key quality metrics and provide regular reports to senior management.
- Stay abreast of evolving regulatory guidelines and industry best practices.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related life science field. Master's degree is preferred.
- Minimum of 7 years of progressive experience in pharmaceutical Quality Assurance.
- In-depth knowledge of GMP, ICH guidelines, and regulatory affairs within the pharmaceutical industry.
- Proven experience in auditing, CAPA management, and risk assessment.
- Strong leadership and team management skills.
- Excellent analytical, problem-solving, and decision-making abilities.
- Proficiency in regulatory submission processes and documentation.
- Effective communication and interpersonal skills, with the ability to engage stakeholders at all levels.
This advertiser has chosen not to accept applicants from your region.
4
Senior Pharmaceutical Quality Assurance Manager
Posted 12 days ago
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Job Description
Our client, a distinguished leader in pharmaceutical innovation and manufacturing, is seeking an experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to oversee and enhance their quality systems. This is a pivotal role within a fully remote structure, allowing you to contribute your expertise and leadership to our global operations, including our facilities and impact in **Mombasa, Mombasa, KE**. The ideal candidate will possess a comprehensive understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory requirements across international markets. You will be instrumental in ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy. Key responsibilities include: developing, implementing, and maintaining robust quality management systems, overseeing the validation of manufacturing processes and equipment, conducting internal and external audits to ensure compliance, managing deviations, CAPAs (Corrective and Preventive Actions), and change controls, reviewing and approving batch records and quality documentation, training and mentoring QA personnel, collaborating with regulatory affairs to ensure compliance with evolving regulations, and driving continuous improvement initiatives within the quality unit. The successful candidate will demonstrate exceptional leadership skills, strong analytical and problem-solving abilities, and a meticulous attention to detail. Excellent communication and interpersonal skills are essential for effectively collaborating with cross-functional teams and external stakeholders. This is a unique opportunity to make a significant impact on patient safety and product quality within the pharmaceutical industry, all from a remote work environment. Join our client and be at the forefront of ensuring excellence in pharmaceutical production.
This advertiser has chosen not to accept applicants from your region.
5
Senior Pharmaceutical Quality Assurance Manager
Posted 8 days ago
Job Viewed
Job Description
Our client, a leading innovator in the pharmaceutical industry, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to join our fully remote, global quality team. This critical role is responsible for ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, in strict adherence to regulatory requirements. You will lead the development, implementation, and maintenance of robust Quality Management Systems (QMS), oversee compliance with Good Manufacturing Practices (GMP), and conduct comprehensive quality risk assessments. This position requires extensive knowledge of pharmaceutical manufacturing processes, regulatory affairs, and quality control methodologies. You will collaborate closely with R&D, manufacturing, and regulatory affairs departments to uphold our client's commitment to excellence. The ideal candidate possesses strong leadership skills, exceptional analytical abilities, and meticulous attention to detail, with the capability to drive continuous improvement in quality processes.
Responsibilities:
Responsibilities:
- Develop, implement, and manage the Quality Management System (QMS) to ensure compliance with global pharmaceutical regulations (e.g., FDA, EMA, WHO).
- Oversee and ensure adherence to Good Manufacturing Practices (GMP) across all pharmaceutical operations.
- Conduct comprehensive quality risk assessments and implement mitigation strategies.
- Lead internal audits and support external regulatory inspections, ensuring readiness and compliance.
- Review and approve batch records, validation protocols, and other critical quality documentation.
- Investigate deviations, out-of-specification results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Manage the change control process for materials, equipment, and processes affecting product quality.
- Provide training and guidance to quality personnel and cross-functional teams on quality standards and regulatory requirements.
- Monitor industry trends and regulatory updates, ensuring the QMS remains current and effective.
- Contribute to the development and improvement of pharmaceutical manufacturing processes and product quality.
- Collaborate with R&D and manufacturing teams to ensure smooth technology transfer and product launch processes.
- Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8 years of progressive experience in Pharmaceutical Quality Assurance or Quality Control.
- In-depth knowledge of pharmaceutical manufacturing processes, analytical methods, and regulatory requirements (e.g., ICH guidelines, GMP, GLP).
- Proven experience in developing, implementing, and managing Quality Management Systems (QMS).
- Strong understanding of quality risk management principles and their application.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional leadership, communication, and interpersonal skills.
- Ability to work independently and lead cross-functional teams in a remote environment.
- Experience with regulatory agency inspections (e.g., FDA, EMA).
- Proficiency in quality management software and tools.
This advertiser has chosen not to accept applicants from your region.
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6
Senior Pharmaceutical Quality Assurance Manager
Posted 9 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and detail-oriented Senior Pharmaceutical Quality Assurance Manager to join their fully remote team. This critical role ensures adherence to stringent quality standards and regulatory compliance throughout the pharmaceutical product lifecycle. You will be responsible for developing, implementing, and maintaining robust Quality Management Systems (QMS) to guarantee the safety, efficacy, and quality of our pharmaceutical products.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and manage comprehensive Quality Management Systems (QMS) in accordance with cGMP, ICH, and other relevant regulatory guidelines.
- Oversee all aspects of quality assurance, including batch record review, deviation management, CAPA (Corrective and Preventive Actions), change control, and internal audits.
- Ensure compliance with all applicable regulatory requirements from agencies such as the FDA, EMA, and local health authorities.
- Lead and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement.
- Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance and identify areas for improvement.
- Review and approve validation protocols and reports for equipment, processes, and analytical methods.
- Manage external audits from regulatory agencies and clients, and ensure timely response to any findings.
- Develop and maintain quality agreements with contract manufacturing organizations (CMOs) and suppliers.
- Monitor key quality metrics and provide regular reports to senior management.
- Investigate product quality complaints and implement necessary corrective actions.
- Contribute to the risk assessment process for product development and manufacturing.
- Ensure the effective training of personnel on quality systems and regulatory requirements.
- Approve product release based on review of manufacturing and quality control data.
- Stay current with evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
This advertiser has chosen not to accept applicants from your region.
7
Senior Pharmaceutical Quality Assurance Manager
Posted 9 days ago
Job Viewed
Job Description
Our client is looking for an experienced Senior Pharmaceutical Quality Assurance Manager to oversee their quality systems and compliance initiatives in a fully remote capacity. This role is critical in ensuring that all pharmaceutical products meet rigorous quality standards and regulatory requirements. You will be responsible for developing, implementing, and maintaining quality management systems, conducting internal audits, and managing external inspections. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, Good Manufacturing Practices (GMP), and relevant regulatory frameworks (e.g., FDA, EMA, WHO). Your responsibilities will include reviewing batch records, investigating deviations and out-of-specification results, managing CAPA (Corrective and Preventive Actions), and ensuring product integrity throughout the lifecycle. Strong analytical and problem-solving skills are essential, as is the ability to interpret complex data and scientific information. Excellent communication and leadership skills are required to effectively collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, remotely. You must be a detail-oriented, organized, and proactive individual capable of managing multiple priorities and driving continuous improvement initiatives from a remote setting. A proven track record in pharmaceutical quality assurance or quality control is mandatory. This is an exceptional opportunity to contribute to ensuring the safety and efficacy of pharmaceutical products. Your remote oversight will be instrumental in upholding standards for products associated with operations serving the region of Mombasa, Mombasa, KE .
This advertiser has chosen not to accept applicants from your region.
8
Senior Pharmaceutical Quality Assurance Manager
Posted 4 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical company committed to advancing healthcare, is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to join their team in **Mombasa, Mombasa, KE**. This role is critical in ensuring that all pharmaceutical products manufactured and distributed meet the highest standards of quality, safety, and efficacy, adhering strictly to regulatory requirements such as GMP (Good Manufacturing Practices) and GXP guidelines. The ideal candidate will possess a deep understanding of the pharmaceutical industry, regulatory affairs, and robust quality management systems. You will be responsible for developing, implementing, and maintaining comprehensive QA policies and procedures across all operational facets. This includes overseeing batch record review and release, managing deviations and CAPAs (Corrective and Preventive Actions), conducting internal audits, and leading external regulatory inspections. Your expertise will be vital in ensuring compliance with national and international pharmaceutical regulations. You will also play a key role in the qualification and validation of equipment, processes, and analytical methods. This position requires leading and mentoring a team of QA professionals, fostering a culture of continuous improvement and quality consciousness throughout the organization. You will be responsible for risk assessments, change control management, and ensuring that all quality-related documentation is accurate, complete, and compliant. Strong leadership, analytical, and problem-solving skills are essential, as is the ability to communicate effectively with regulatory bodies, internal departments, and external partners. Experience in pharmaceutical manufacturing, quality control, or regulatory affairs is a prerequisite. If you are a dedicated QA leader passionate about ensuring product integrity and patient safety within the pharmaceutical sector, this opportunity offers significant professional growth and the chance to make a substantial impact.
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