Quality Assurance Manager Job Vacancy in East London, South Africa – Pharmaceutical Manufacturing

Pfizer South Africa is a leading global biopharmaceutical company dedicated to improving health outcomes through innovative medicines, vaccines, and consumer health products. With a strong presence across the African continent, Pfizer combines cutting-edge research with local expertise to deliver high-quality therapeutics that address the unique health challenges of the region. The East London facility focuses on the manufacturing of sterile injectable products, adhering to the highest standards of Good Manufacturing Practice (GMP).

The Quality Assurance Manager will lead the QA team responsible for ensuring that all products manufactured at the East London site meet stringent regulatory requirements and internal quality standards. This role involves overseeing the design, implementation, and continuous improvement of quality systems, conducting internal audits, and collaborating closely with Production, Validation, and Regulatory Affairs to maintain compliance.

Key Responsibilities:

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with GMP, ISO 9001, and local regulatory guidelines.
• Lead internal and external audits, including FDA, EMA, and South African Health Products Regulatory Authority (SAHPRA) inspections.
• Manage deviation investigations, root-cause analysis, and corrective and preventive actions (CAPA) to ensure timely resolution.
• Collaborate with Production and Validation teams to qualify equipment, processes, and facilities.
• Oversee release testing, batch record review, and product disposition decisions.
• Provide training and mentorship to QA staff, fostering a culture of continuous improvement.
• Prepare and present quality performance metrics to senior management and stakeholders.
• Ensure effective change control management and impact assessments for all process changes.

Required Skills:

• In-depth knowledge of GMP, cGMP, and pharmaceutical regulatory requirements.
• Strong analytical and problem-solving abilities with a data-driven mindset.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Proficiency in quality management software and electronic batch record systems.
• Leadership experience with the ability to motivate and develop teams.
• Attention to detail and a commitment to maintaining the highest quality standards.

Education:

A Bachelor’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related discipline is required. Advanced qualifications such as a Master’s degree or professional certifications (e.g., CQE, CQA) are highly desirable and will be considered an asset.

Experience:

Candidates must have a minimum of five years of progressive experience in pharmaceutical quality assurance, with at least two years in a supervisory or managerial capacity. Experience within a sterile manufacturing environment and familiarity with SAHPRA inspections are strongly preferred.

Salary:

The position offers a competitive salary range of ZAR 600,000 to ZAR 900,000 per annum, commensurate with experience and qualifications. Additional performance-based incentives may be provided.

Benefits:

• Comprehensive medical, dental, and vision coverage.
• Retirement savings plan with company matching contributions.
• Generous paid time off and parental leave.
• Employee assistance program and wellness initiatives.
• Professional development budget and tuition reimbursement.

Training:

• Onboarding program covering GMP, QMS, and Pfizer’s corporate policies.
• Continuous learning opportunities through internal workshops, external conferences, and e-learning platforms.
• Leadership development tracks for high-potential managers.

Working Environment:

Pfizer’s East London site provides a modern, state-of-the-art manufacturing environment with advanced clean-room facilities, robust safety protocols, and a collaborative culture. Employees benefit from a supportive atmosphere that encourages innovation, respects diversity, and promotes work-life balance.

Equal Opportunity Statement:

Pfizer South Africa is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.