9 Principal Pharmaceutical Quality Assurance Manager jobs in whatjobs
Principal Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and strategic Principal Pharmaceutical Quality Assurance Manager to lead and enhance their quality systems. This is a crucial, fully remote position requiring extensive expertise in pharmaceutical regulations, GMP, and quality management principles. You will be responsible for developing, implementing, and maintaining robust quality assurance programs that ensure product integrity, regulatory compliance, and operational excellence across all functions. The role involves overseeing audits (internal and external), managing deviations and CAPAs, reviewing and approving documentation (e.g., batch records, validation protocols), and driving continuous improvement initiatives. You will collaborate closely with R&D, manufacturing, regulatory affairs, and other departments to foster a culture of quality throughout the organization. The ideal candidate will possess strong analytical skills, meticulous attention to detail, and the ability to make sound decisions in complex regulatory environments. This remote role requires exceptional leadership qualities and the capability to effectively manage a global team and processes. Your insights will be critical in identifying potential quality risks and implementing proactive solutions. This is an opportunity to make a significant impact on patient safety and product quality within a leading pharmaceutical organization.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with global regulatory standards (e.g., FDA, EMA, WHO).
- Lead and manage internal and external audits, ensuring readiness for regulatory inspections.
- Oversee the investigation of deviations, out-of-specification (OOS) results, and customer complaints, implementing effective corrective and preventive actions (CAPA).
- Review and approve critical quality documents, including SOPs, batch records, validation reports, and change controls.
- Provide quality oversight for product development, manufacturing, and lifecycle management.
- Train and mentor QA staff and other personnel on quality systems and regulatory requirements.
- Drive continuous improvement initiatives to enhance product quality and process efficiency.
- Act as a primary quality contact for regulatory agencies and external partners.
- Stay current with evolving pharmaceutical regulations and industry best practices.
- Ensure the quality of outsourced activities and contract manufacturing organizations.
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 12 years of experience in pharmaceutical quality assurance and quality control, with a significant portion in leadership roles.
- In-depth knowledge of cGMP, ICH guidelines, and global regulatory requirements.
- Proven experience in developing and managing QMS, conducting audits, and handling regulatory inspections.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong leadership and team management capabilities, especially in a remote setting.
- Exceptional written and verbal communication skills, with the ability to present complex information clearly.
- Experience with pharmaceutical manufacturing processes and product development is essential.
- Proficiency in quality management software.
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Principal Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a leading entity in the Pharmaceutical sector, is seeking an experienced and meticulous Principal Pharmaceutical Quality Assurance Manager. This crucial, fully remote role is responsible for upholding the highest standards of quality and compliance across all pharmaceutical operations. You will lead the development, implementation, and maintenance of robust quality management systems, ensuring adherence to regulatory requirements such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Distribution Practices (GDP). The successful candidate will oversee quality control processes, conduct internal and external audits, manage deviation investigations, and ensure the timely resolution of quality-related issues. Your responsibilities will include managing the lifecycle of pharmaceutical products from development through to market release, ensuring all stages meet stringent quality benchmarks. You will collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, providing expert guidance on quality matters. The ideal candidate will possess a deep understanding of pharmaceutical regulations, quality systems, and risk management principles. Strong analytical, problem-solving, and communication skills are essential, as is the ability to lead and mentor a team of quality assurance professionals remotely. You will be instrumental in driving a culture of quality excellence throughout the organization. This position demands exceptional attention to detail, a proactive approach to identifying potential risks, and the ability to make sound, data-driven decisions. This is a challenging and rewarding opportunity for a seasoned QA professional to significantly impact product safety and efficacy within a leading pharmaceutical company. Your leadership will ensure that all products consistently meet or exceed established quality standards and regulatory expectations.Location: Machakos, Machakos, KE
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Principal Pharmaceutical Quality Assurance Manager
Posted 18 days ago
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Job Description
Our client is seeking a highly experienced and strategic Principal Pharmaceutical Quality Assurance Manager to lead and enhance their global quality assurance initiatives. This is a fully remote position, offering the unparalleled flexibility to manage critical quality operations from your chosen location. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) that comply with international pharmaceutical regulations (e.g., GMP, FDA, EMA). Your role will involve overseeing all aspects of quality control, quality assurance, and regulatory compliance, including batch record review, process validation, deviation management, change control, and internal/external audits. You will lead a team of QA professionals, providing mentorship and strategic direction. The ideal candidate will possess a strong scientific background (e.g., Pharmacy, Chemistry, Biology) and extensive experience in the pharmaceutical industry, with a proven track record in managing complex QA functions. Exceptional leadership, analytical, and problem-solving skills are essential, as is a thorough understanding of pharmaceutical manufacturing processes and regulatory landscapes. As a remote manager, you will excel at leveraging digital collaboration tools, conducting virtual audits, and communicating effectively across global teams. You will champion a culture of quality and continuous improvement throughout the organization. We are looking for a visionary leader committed to ensuring the safety, efficacy, and quality of pharmaceutical products. If you are a seasoned QA professional seeking a high-impact, remote leadership role where you can drive significant advancements in pharmaceutical quality, this opportunity is ideal for you. Your strategic oversight will be crucial in maintaining regulatory compliance and upholding the highest standards of product integrity. You will be instrumental in preparing for and managing regulatory inspections.
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2
Principal Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is searching for a highly experienced and strategic Principal Pharmaceutical Quality Assurance Manager to oversee and elevate their quality management systems. This crucial role is a fully remote position, enabling you to contribute significantly to our global operations from your home office. You will be responsible for establishing, maintaining, and improving comprehensive QA policies and procedures to ensure compliance with all relevant regulatory standards (e.g., GMP, ICH, FDA). Key duties include leading internal and external audits; managing deviations, CAPAs, and change control processes; overseeing validation activities for manufacturing processes, equipment, and analytical methods; developing and delivering quality training programs to personnel; collaborating with regulatory affairs to prepare for and manage inspections; analyzing quality data to identify trends and implement continuous improvement initiatives; managing a team of QA professionals (if applicable) in a remote setting; and staying ahead of evolving regulatory landscapes. The ideal candidate will possess an advanced degree in Pharmacy, Chemistry, Biology, or a related life science field, coupled with extensive experience in pharmaceutical quality assurance and regulatory compliance. Proven leadership skills, exceptional analytical and problem-solving capabilities, and outstanding written and verbal communication skills are essential for effective remote leadership and collaboration. Expertise in quality risk management, validation principles, and audit management is required. A deep understanding of the pharmaceutical drug development and manufacturing lifecycle is critical. This is an unparalleled opportunity to shape the quality culture of a major pharmaceutical player and ensure the safety and efficacy of vital medicines, working remotely to support our strategic goals impacting the Nakuru, Nakuru, KE region and beyond.
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3
Principal Pharmaceutical Quality Assurance Manager
Posted 19 days ago
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Job Description
Our client is seeking a highly experienced and meticulous Principal Pharmaceutical Quality Assurance Manager to oversee and elevate quality systems within their globally distributed operations, entirely remotely. This leadership position is central to ensuring compliance with all relevant pharmaceutical regulations, Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP). The ideal candidate will possess an in-depth understanding of the pharmaceutical lifecycle, from R&D to commercialization, and have a proven history of implementing and maintaining robust quality management systems (QMS). Responsibilities include developing and executing quality strategies, conducting internal and external audits, managing deviations and CAPAs, and leading cross-functional teams in quality improvement initiatives. You will be instrumental in ensuring product integrity, safety, and efficacy by upholding the highest standards of quality across all operations. This role requires exceptional analytical and problem-solving skills, strong leadership capabilities, and outstanding communication and interpersonal abilities to effectively manage remote teams and collaborate with global stakeholders. You must be adept at interpreting complex regulatory guidelines and translating them into practical, implementable quality procedures. The ability to drive a culture of quality excellence and continuous improvement throughout the organization is crucial. We are looking for a proactive individual who can anticipate potential quality risks and implement preemptive measures. This is a significant opportunity to shape the quality framework of a leading pharmaceutical entity from a remote setting, contributing directly to patient safety and regulatory compliance. Your expertise will be vital in maintaining the highest standards for our products serving regions including **Ruiru, Kiambu, KE**.
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4
Principal Pharmaceutical Quality Assurance Manager
Posted 10 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking an accomplished Principal Pharmaceutical Quality Assurance Manager. This is a pivotal, fully remote leadership position, responsible for upholding the highest standards of quality across all pharmaceutical operations. The ideal candidate will possess extensive experience in pharmaceutical quality management systems, regulatory compliance, and GMP (Good Manufacturing Practices). You will lead a team of QA professionals, develop and implement robust quality control strategies, and ensure that all products meet stringent safety and efficacy requirements. This role demands meticulous attention to detail, strong analytical capabilities, and the ability to navigate complex regulatory landscapes. Joining our client means contributing to the development of life-saving medications while working in a flexible, remote setting.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Assurance (QA) programs and systems.
- Ensure compliance with all relevant pharmaceutical regulations, including GMP, ICH guidelines, and FDA/EMA requirements.
- Lead and manage the QA team, providing guidance, training, and performance management.
- Oversee the review and approval of batch records, validation protocols, and SOPs.
- Conduct internal and external audits to assess compliance and identify areas for improvement.
- Investigate deviations, root causes, and implement corrective and preventive actions (CAPAs).
- Manage change control processes and ensure proper documentation.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality.
- Review and approve product labeling, specifications, and testing methods.
- Stay updated on evolving regulatory requirements and industry best practices.
- Develop and deliver training programs on quality assurance principles and practices.
- Serve as the primary point of contact for regulatory inspections.
- Contribute to the strategic direction of the company's quality objectives.
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
- 12+ years of progressive experience in pharmaceutical Quality Assurance/Quality Control.
- In-depth knowledge of GMP, GLP, GCP, and other relevant quality standards.
- Proven experience in leading and managing QA teams.
- Strong understanding of pharmaceutical manufacturing processes and drug development lifecycle.
- Demonstrated success in managing regulatory inspections and audits.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with strong report-writing capabilities.
- Experience with validation processes (process, cleaning, equipment).
- Ability to work independently and make critical decisions in a remote environment.
- Pharmaceutical quality certifications (e.g., ASQ CQM) are highly desirable.
This advertiser has chosen not to accept applicants from your region.
5
Principal Pharmaceutical Quality Assurance Manager
Posted 7 days ago
Job Viewed
Job Description
Our client, a prominent entity in the pharmaceutical sector, is seeking an experienced Principal Pharmaceutical Quality Assurance Manager to lead their remote quality operations. This crucial role will oversee the development, implementation, and maintenance of robust quality management systems across all stages of pharmaceutical product lifecycle, from development to post-market surveillance. As a fully remote leader, you will be responsible for ensuring compliance with global regulatory standards, including GMP, GDP, and ICH guidelines. Your duties will involve conducting internal and external audits, managing deviation investigations, implementing CAPA strategies, and driving continuous improvement initiatives. You will also provide expert guidance on quality-related matters to project teams and senior management. The ideal candidate will possess a Master's degree or PhD in Pharmacy, Chemistry, or a related scientific field, with extensive experience in pharmaceutical quality assurance and regulatory affairs. Demonstrated leadership skills, a deep understanding of pharmaceutical manufacturing processes, and a strong track record in successful regulatory inspections are required. This is an exceptional remote opportunity to shape the quality culture of a growing pharmaceutical organization and ensure the highest standards of product safety and efficacy. You will be a key player in maintaining compliance and driving excellence in quality assurance, contributing significantly to the company's reputation and success. The ability to work independently, manage complex projects, and communicate effectively with stakeholders at all levels is paramount for this role. Join us to make a tangible difference in the quality and safety of medicines worldwide.
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Principal Pharmaceutical Quality Assurance Manager
Posted 6 days ago
Job Viewed
Job Description
Our client is seeking a highly accomplished Principal Pharmaceutical Quality Assurance Manager to oversee and elevate their quality systems. This is a critical, fully remote leadership position within their global pharmaceutical operations. The ideal candidate will possess extensive experience in pharmaceutical quality assurance, regulatory compliance, and quality management systems. You will be responsible for developing, implementing, and maintaining comprehensive QA policies and procedures to ensure compliance with international regulatory standards (e.g., FDA, EMA, WHO). This includes overseeing internal and external audits, managing deviations, change controls, and CAPA systems. The Principal QA Manager will lead cross-functional teams, providing expert guidance on quality-related matters and fostering a strong quality culture throughout the organization. You will review and approve critical quality documents, including validation protocols, manufacturing batch records, and stability studies. Experience with GxP environments (GMP, GLP, GCP) is essential. As a remote-first leader, you will leverage digital collaboration tools to effectively manage global teams and initiatives. The ability to identify potential quality risks, implement robust risk mitigation strategies, and drive continuous improvement in quality processes is paramount. Strong analytical, problem-solving, and decision-making skills are required. You will also play a key role in preparing for and hosting regulatory inspections. This is an exceptional opportunity to shape the quality landscape of a leading pharmaceutical company, driving excellence and ensuring product integrity from a flexible, remote work setting. Your expertise will be vital in maintaining the highest standards of quality and compliance.
This advertiser has chosen not to accept applicants from your region.
7
Principal Pharmaceutical Quality Assurance Manager
Posted 6 days ago
Job Viewed
Job Description
Our client is seeking to recruit a highly experienced and results-oriented Principal Pharmaceutical Quality Assurance Manager. This crucial role operates on a fully remote basis, offering an unparalleled opportunity to manage and elevate quality systems from any location. The Principal Pharmaceutical Quality Assurance Manager will be responsible for developing, implementing, and maintaining robust quality assurance strategies and systems across the pharmaceutical product lifecycle. This includes ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other relevant regulatory standards globally. Key responsibilities encompass overseeing quality control processes, managing batch record reviews, conducting internal and external audits, and leading quality improvement initiatives. You will also play a pivotal role in preparing for and managing regulatory inspections, ensuring all documentation and processes meet the highest standards. The position requires close collaboration with R&D, manufacturing, regulatory affairs, and other departments to foster a strong quality culture throughout the organization. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, or a related scientific field, along with a minimum of 10 years of progressive experience in pharmaceutical quality assurance and quality control. A deep understanding of global pharmaceutical regulations (FDA, EMA, etc.) and a proven track record in successfully managing quality systems and audits are essential. Exceptional leadership, communication, and problem-solving skills are required, along with the ability to mentor and guide junior quality professionals. Experience with quality management software and a strong commitment to continuous improvement are highly desirable. This remote position is ideal for a seasoned QA professional looking to make a significant impact from a flexible, home-based work environment, ensuring the highest standards of product quality and patient safety.
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