Lead Pharmaceutical Quality Assurance Manager

Placements24; Pretoria; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Competitive remuneration

Medical and dental insurance

Retirement plan

Professional development

Hybrid work model

Job summary

Placements24 is seeking a Lead Pharmaceutical Quality Assurance Manager for our client in Pretoria, Gauteng. This hybrid role combines on-site leadership with strategic remote planning to maintain top-tier QA/QMS across pharmaceutical operations.

You will ensure products meet strict quality, safety, and regulatory standards and guide a high-performing QA team. The ideal candidate has 7+ years in pharmaceutical QA, strong GMP and regulatory experience, and proven leadership.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific discipline.
• Master's degree or advanced certification in Quality Assurance is preferred.

Responsibilities

• Develop, implement, and maintain QA/QMS in line with GMP and regulatory standards.
• Lead and mentor the QA team and foster continuous improvement.
• Oversee batch record reviews, deviations, CAPA, change control, and OOS investigations.
• Conduct internal audits and support regulatory and customer audits.
• Manage vendor qualification and quality agreements to ensure supply chain integrity.
• Review and approve validation protocols and reports for manufacturing and analytical methods.
• Monitor quality metrics and report trends to senior management.

Skills

Leadership

GMP knowledge

Quality management

Regulatory compliance

Audits

Education

Bachelor's degree in Pharmacy or related field

Master's degree or QA certification

Job description

About the Role

Our client, a distinguished name in the pharmaceutical industry, is seeking a highly experienced and driven Lead Pharmaceutical Quality Assurance Manager to join their team in Pretoria, Gauteng . This critical leadership role involves overseeing and enhancing the quality management systems across all pharmaceutical operations. You will be responsible for ensuring that all products meet the highest standards of quality, safety, and efficacy, adhering strictly to national and international regulatory requirements. This hybrid position offers a compelling blend of on-site leadership and strategic remote planning, providing flexibility while maintaining robust oversight. The ideal candidate will possess a deep understanding of GMP, quality control, and regulatory compliance, with a proven ability to lead and inspire QA teams. Join us in safeguarding public health through unwavering commitment to pharmaceutical excellence in Pretoria .

Key Responsibilities

• Develop, implement, and maintain comprehensive Quality Assurance (QA) and Quality Management Systems (QMS) in compliance with GMP and regulatory standards.
• Lead and mentor the QA team, providing guidance and fostering a culture of continuous improvement.
• Oversee all quality-related activities, including batch record review, deviation management, CAPA implementation, change control, and OOS investigations.
• Conduct internal audits and support external audits by regulatory authorities and customers.
• Manage vendor qualification and quality agreements to ensure supply chain integrity.
• Review and approve validation protocols and reports for manufacturing processes, equipment, and analytical methods.
• Monitor key quality metrics and prepare reports for senior management, identifying trends and areas for improvement.
• Ensure compliance with relevant pharmaceutical regulations, including those set by SAHPRA and international bodies.
• Act as a key point of contact for quality-related inquiries and ensure prompt resolution of issues.
• Contribute to the strategic planning and execution of quality initiatives within the Pretoria facility.

Requirements

• A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• A Master's degree or advanced certification in Quality Assurance is preferred.
• A minimum of 7 years of progressive experience in pharmaceutical Quality Assurance, with at least 3 years in a managerial or supervisory role.
• In-depth knowledge of GMP regulations, quality systems, and pharmaceutical manufacturing processes.
• Proven experience in managing audits (internal and external), regulatory inspections, and CAPA systems.
• Strong leadership, team management, and interpersonal skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Proficiency in risk management principles and their application in a pharmaceutical setting.
• Exceptional written and verbal communication skills, with the ability to effectively communicate with all levels of the organization and external stakeholders.
• Experience working with hybrid work models and managing remote team members is beneficial.
• Familiarity with pharmaceutical product development lifecycle.

Benefits

• Our client offers a competitive remuneration package, including a generous salary and potential for performance bonuses.
• Employees receive comprehensive medical and dental insurance, a robust retirement fund, and paid time off.
• Opportunities for professional development, including advanced training and certifications, are readily available.
• This hybrid role provides the flexibility to balance on-site collaboration and strategic remote work, centered at our modern facility in Pretoria .
• Join a company dedicated to upholding the highest quality standards in the pharmaceutical industry.