About the Role
Our client, a prominent entity in the **Pharmaceutical** sector, is seeking an accomplished Senior Quality Assurance Manager to lead their quality operations in **Johannesburg, Gauteng, ZA**. This pivotal role demands a strategic thinker with extensive experience in pharmaceutical quality systems, regulatory compliance, and risk management. The successful candidate will be responsible for maintaining the highest standards of quality across all aspects of pharmaceutical manufacturing and distribution, ensuring adherence to national and international regulatory requirements. This position offers a significant opportunity to influence quality strategy, drive continuous improvement initiatives, and foster a robust quality culture within a leading South African pharmaceutical organization. You will play a key role in safeguarding product integrity and patient safety, working closely with regulatory bodies and internal teams. The ideal candidate will bring a wealth of knowledge and leadership to our **Johannesburg**-based operations.
Key Responsibilities
- Develop, implement, and maintain a comprehensive Quality Management System (QMS) in compliance with GMP, GDP, and relevant regulatory standards (e.g., SAHPRA).
- Oversee all quality assurance activities, including batch record review, deviation management, CAPA implementation, and change control.
- Lead and manage internal and external audits, ensuring readiness for regulatory inspections.
- Establish and monitor key quality performance indicators (KPIs) and implement improvement strategies.
- Manage and mentor the Quality Assurance team, fostering professional development and high performance.
- Ensure robust supplier qualification and quality oversight programs.
- Review and approve validation protocols and reports for manufacturing processes and equipment.
- Investigate product quality complaints and ensure timely and effective resolution.
- Contribute to new product introductions, ensuring quality considerations are addressed from development through to commercialization.
- Promote a quality-focused culture throughout the organization.
Requirements
- Master's degree or PhD in Pharmacy, Chemistry, Microbiology, or a related life science field.
- Minimum of 8 years of progressive experience in Quality Assurance within the **Pharmaceutical** industry.
- In-depth knowledge of GMP, ICH guidelines, and South African pharmaceutical regulations.
- Proven experience in managing QMS, conducting audits, and handling regulatory inspections.
- Demonstrated leadership skills with experience managing QA teams.
- Strong understanding of pharmaceutical manufacturing processes, validation, and risk management.
- Excellent analytical, problem-solving, and decision-making capabilities.
- Exceptional written and verbal communication skills, with strong presentation abilities.
- Experience working within the **Gauteng, ZA** pharmaceutical landscape is highly desirable.
Benefits
- Highly competitive salary package with performance-related bonuses.
- Comprehensive health insurance including medical, dental, and vision coverage.
- Generous pension fund contribution.
- Opportunities for international training and conferences.
- Professional development and career growth pathways.
- Significant paid annual leave and public holidays.
- Access to state-of-the-art facilities in **Johannesburg**.
- Relocation assistance for candidates relocating to **Gauteng, ZA**.