6 Principal Pharmaceutical Quality Assurance Manager Remote jobs in whatjobs
Principal Pharmaceutical Quality Assurance Manager (Remote)
Posted 22 days ago
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Job Description
Our client is seeking a highly accomplished and experienced Principal Pharmaceutical Quality Assurance Manager to lead their global quality operations from a remote setting. This critical role demands extensive expertise in pharmaceutical quality systems, regulatory compliance, and strategic leadership. You will be responsible for ensuring the highest standards of quality and compliance across all pharmaceutical manufacturing and development activities. This is a fully remote position, offering the flexibility to work from anywhere. The ideal candidate will have a proven track record of successfully implementing and managing robust quality assurance programs in a GxP environment.
Responsibilities:
Qualifications:
This is a remote position, with the original operational focus being **Eldoret, Uasin Gishu, KE**. We are seeking a world-class quality leader to uphold our client's commitment to excellence in pharmaceutical manufacturing.
Responsibilities:
- Develop, implement, and maintain comprehensive pharmaceutical quality management systems (QMS) in compliance with global regulatory requirements (e.g., FDA, EMA, WHO).
- Lead and manage QA operations, including batch record review, deviation management, CAPA, change control, and internal/external audits.
- Provide strategic direction and leadership to the QA team, fostering a culture of quality and continuous improvement.
- Oversee the qualification and validation of manufacturing processes, equipment, and analytical methods.
- Ensure compliance with cGMP, ICH guidelines, and other relevant regulatory standards.
- Act as a primary contact for regulatory agencies during inspections and inquiries.
- Review and approve key quality-related documents, including SOPs, validation protocols, and reports.
- Conduct risk assessments and implement mitigation strategies to ensure product quality and patient safety.
- Stay current with evolving regulatory landscapes and implement necessary updates to quality systems.
- Mentor and develop QA personnel.
Qualifications:
- Master's or Ph.D. in Pharmacy, Chemistry, Biological Sciences, or a related field.
- Minimum of 10-12 years of progressive experience in pharmaceutical quality assurance and quality control, with at least 5 years in a management or leadership role.
- Extensive knowledge of cGMP, GxP, and regulatory requirements from major health authorities.
- Proven experience in leading successful regulatory inspections and managing complex quality systems.
- Strong understanding of pharmaceutical manufacturing processes, analytical testing, and validation principles.
- Exceptional leadership, strategic planning, and problem-solving skills.
- Excellent written and verbal communication skills, with the ability to effectively communicate complex quality issues to senior management and regulatory bodies.
- Experience managing remote QA teams and distributed operations.
- Proficiency in quality management software and electronic QMS.
This is a remote position, with the original operational focus being **Eldoret, Uasin Gishu, KE**. We are seeking a world-class quality leader to uphold our client's commitment to excellence in pharmaceutical manufacturing.
This advertiser has chosen not to accept applicants from your region.
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Principal Pharmaceutical Quality Assurance Manager (Remote)
Posted 7 days ago
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Job Description
Our client, a globally recognized pharmaceutical company committed to improving health outcomes, is seeking an exceptional Principal Pharmaceutical Quality Assurance Manager to lead their fully remote QA operations. This senior role is instrumental in ensuring compliance with stringent regulatory standards, driving quality initiatives, and upholding the integrity of our client's pharmaceutical products. You will leverage your extensive expertise to maintain the highest levels of quality across all stages of the product lifecycle, from development to post-market surveillance, all within a remote framework.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain a robust Quality Management System (QMS) in alignment with global regulatory requirements (e.g., FDA, EMA, WHO GMP).
- Oversee and conduct internal audits and inspections to ensure compliance with SOPs, GMP, and regulatory guidelines.
- Manage external audits and inspections from regulatory authorities and partners, ensuring successful outcomes.
- Lead the investigation of deviations, out-of-specification (OOS) results, and customer complaints, ensuring thorough root cause analysis and effective CAPA implementation.
- Review and approve critical quality documents, including validation protocols, SOPs, batch records, and change controls.
- Provide expert guidance and interpretation of pharmaceutical quality regulations and guidelines to relevant departments.
- Develop and deliver training programs on quality assurance principles and GMP compliance for employees.
- Monitor and analyze quality metrics, identifying trends and implementing proactive measures to enhance product quality and process efficiency.
- Collaborate closely with R&D, manufacturing, regulatory affairs, and other departments to ensure a cohesive quality approach.
- Stay abreast of evolving regulatory landscapes, industry best practices, and emerging quality technologies.
- Champion a strong quality culture throughout the organization, fostering a commitment to excellence and compliance.
- Manage the lifecycle of quality-related documentation, ensuring accuracy, completeness, and adherence to retention policies.
- Lead risk management activities related to product quality and regulatory compliance.
- Master's or Ph.D. in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
- A minimum of 10-15 years of progressive experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
- In-depth knowledge of Good Manufacturing Practices (GMP), ICH guidelines, and other relevant regulatory standards.
- Proven experience in developing, implementing, and managing QMS in a regulated pharmaceutical environment.
- Demonstrated expertise in quality risk management, deviation management, CAPA, and validation processes.
- Excellent leadership, analytical, problem-solving, and decision-making skills.
- Exceptional communication and interpersonal skills, with the ability to influence stakeholders at all levels.
- Demonstrated ability to work effectively in a fully remote setting, manage complex projects, and lead distributed teams.
- Experience with electronic QMS (eQMS) platforms and data analytics tools.
- Professional certifications such as CQPA, CQM, or RAC are highly valued.
- A strong understanding of drug development, manufacturing, and analytical testing processes.
This advertiser has chosen not to accept applicants from your region.
1
Principal Pharmaceutical Quality Assurance Manager (Remote)
Posted 4 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical company, is seeking a highly experienced and strategic Principal Pharmaceutical Quality Assurance Manager to lead their quality operations. This is a critical, fully remote position responsible for establishing, implementing, and maintaining a robust quality management system (QMS) that ensures compliance with international regulatory standards (e.g., FDA, EMA, WHO). You will oversee all aspects of quality assurance for drug development, manufacturing, and distribution, working collaboratively with cross-functional teams to uphold the highest standards of product quality and patient safety. Your responsibilities will include conducting internal and external audits, managing regulatory inspections, developing and executing quality risk management strategies, and ensuring the integrity of all quality-related documentation. This role demands a deep understanding of pharmaceutical regulations, GMP/GLP/GCP guidelines, and a proven track record in quality leadership. The ideal candidate will possess exceptional analytical and problem-solving skills, strong leadership capabilities, and the ability to drive quality initiatives across a global, remote workforce. You will be instrumental in continuous improvement efforts, identifying process efficiencies, and implementing best practices in pharmaceutical quality assurance. This is a significant opportunity to shape the quality landscape of a leading pharmaceutical organization from the comfort of your home office. Your expertise will guide the company in maintaining regulatory compliance and ensuring the consistent delivery of safe and effective pharmaceutical products.
Responsibilities:
Responsibilities:
- Develop, implement, and manage the company's pharmaceutical Quality Management System (QMS).
- Ensure compliance with GMP, GLP, GCP, and other relevant regulatory guidelines.
- Lead and conduct internal and external audits of manufacturing sites, suppliers, and partners.
- Manage regulatory agency inspections and respond to audit findings.
- Oversee the qualification and validation of equipment, processes, and systems.
- Develop and implement quality risk management strategies.
- Review and approve critical quality-related documentation, including SOPs, batch records, and validation protocols.
- Investigate deviations, CAPAs, and change controls, ensuring timely and effective resolution.
- Provide training and guidance to internal teams on quality standards and regulatory requirements.
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
- Act as a key point of contact for regulatory agencies on quality matters.
- Stay updated on evolving regulatory landscapes and industry best practices.
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 10 years of progressive experience in pharmaceutical quality assurance and quality control.
- Extensive knowledge of global pharmaceutical regulations (FDA, EMA, ICH) and quality systems.
- Demonstrated experience in leading audits, managing regulatory inspections, and handling deviations/CAPAs.
- Strong leadership, strategic thinking, and problem-solving skills.
- Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.
- Proven ability to work independently and effectively manage a remote team.
- Experience with data analysis and quality metrics reporting.
This advertiser has chosen not to accept applicants from your region.
2
Principal Pharmaceutical Quality Assurance Manager (Remote)
Posted 22 days ago
Job Viewed
Job Description
Our client, a leading innovator in the pharmaceutical industry, is looking for a Principal Pharmaceutical Quality Assurance Manager to join their globally distributed team. This is a critical, fully remote role, empowering you to contribute to life-saving medications from the comfort of your home office. You will be responsible for establishing, maintaining, and improving the overall quality management system (QMS) across all pharmaceutical development and manufacturing processes. This includes ensuring strict adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant international regulatory standards such as FDA, EMA, and WHO guidelines. Your responsibilities will encompass developing and executing comprehensive quality control strategies, performing risk assessments, and managing deviations, CAPAs (Corrective and Preventive Actions), and change controls. You will lead and mentor quality assurance teams, fostering a culture of quality excellence and continuous improvement. Conducting internal and external audits, supplier qualification, and ensuring the integrity of all drug product documentation are integral to this position. You will also play a key role in regulatory submissions and inspections, serving as a subject matter expert on quality matters. The ideal candidate possesses a deep understanding of pharmaceutical sciences, analytical methodologies, and regulatory affairs, coupled with exceptional leadership and problem-solving abilities. Your strategic vision will guide the company's commitment to delivering safe, effective, and high-quality pharmaceutical products to patients worldwide. This remote position demands a proactive approach, strong organizational skills, and the ability to collaborate effectively with cross-functional teams across different time zones. You will be at the forefront of ensuring the highest standards of quality in a rapidly evolving pharmaceutical landscape, driving innovation and patient safety through rigorous QA oversight.
This advertiser has chosen not to accept applicants from your region.
3
Principal Pharmaceutical Quality Assurance Manager (Remote)
Posted 22 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and accomplished Principal Pharmaceutical Quality Assurance Manager to lead their remote QA operations. This senior role is paramount in ensuring the highest standards of quality and compliance are met throughout the pharmaceutical product lifecycle, from research and development to manufacturing and distribution. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS), overseeing all aspects of quality control and assurance, and ensuring adherence to global regulatory requirements (e.g., GMP, ISO). The ideal candidate will possess extensive expertise in pharmaceutical quality assurance, regulatory affairs, and a deep understanding of drug development processes. Proven leadership experience in managing QA teams and driving quality initiatives is essential. Responsibilities include establishing and enforcing quality policies and procedures, conducting internal and external audits, managing deviation investigations and CAPA (Corrective and Preventive Actions), overseeing validation activities, and ensuring the integrity of all quality-related documentation. You will also be responsible for staying current with evolving regulatory landscapes, providing strategic guidance on quality matters, and representing the company during regulatory inspections. This position requires exceptional analytical and problem-solving skills, outstanding communication and interpersonal abilities for effective remote leadership, and the capacity to manage complex projects with meticulous attention to detail. This is an exceptional opportunity to play a leadership role in ensuring the safety and efficacy of pharmaceutical products, contributing to the pharmaceutical industry's advancements relevant to **Embu, Embu, KE**, all while operating from a fully remote capacity. We are looking for a visionary QA leader committed to upholding the highest standards of pharmaceutical quality and regulatory compliance.
This advertiser has chosen not to accept applicants from your region.
4
Principal Pharmaceutical Quality Assurance Manager (Remote)
Posted 19 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced Principal Pharmaceutical Quality Assurance Manager to lead and shape their quality assurance framework within a fully remote operational model. This senior leadership role is vital for ensuring the highest standards of quality, compliance, and regulatory adherence across all pharmaceutical product development and manufacturing processes. The ideal candidate will possess an extensive background in pharmaceutical quality systems (GXP, GMP, ICH guidelines) and a proven ability to manage complex QA initiatives remotely. Responsibilities include developing, implementing, and overseeing robust quality management systems, conducting internal and external audits (virtually), and ensuring adherence to global regulatory requirements. You will be instrumental in driving continuous improvement, managing deviations, CAPAs, and change controls, and fostering a strong quality culture throughout the organization, impacting operations that may be linked to the Embu, Embu, KE region. This role requires exceptional leadership skills, strategic thinking, and the ability to effectively communicate and influence stakeholders at all levels in a remote setting. You will collaborate closely with R&D, manufacturing, and regulatory affairs teams to ensure product integrity and patient safety. Experience in pharmaceutical product lifecycle management and a deep understanding of validation processes are essential. We are looking for a proactive, results-oriented individual with strong analytical and problem-solving capabilities, capable of excelling in an autonomous, remote work environment. This is a key opportunity to influence the quality trajectory of a forward-thinking pharmaceutical company.
This advertiser has chosen not to accept applicants from your region.
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