Senior Pharmaceutical Quality Assurance Manager

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

Benefits offered by this job

Attractive salary with performanceBonu

Comprehensive medical coverage

Pension fund

Professional development

Job summary

Placements24 seeks a Senior Pharmaceutical Quality Assurance Manager to lead QA operations in Vereeniging. The role focuses on implementing and overseeing the QMS to ensure GMP, GDP, and ISO compliance across the product lifecycle.

The ideal candidate will have strong leadership, extensive QA knowledge, and a history of driving continuous improvement to protect patient safety and product integrity.

Qualifications

• Candidate holds a degree in a scientific field and at least 7 years in pharmaceutical QA.
• Proven knowledge of GMP, GDP and regulatory requirements (FDA, EMA, SAHPRA).
• Experience leading QMS, audits and regulatory inspections.

Responsibilities

• Develop and maintain a comprehensive QMS compliant with GMP/GDP and regulations.
• Oversee QA activities including batch release, deviation management and CAPA.
• Lead audits and regulatory inspections, and manage quality agreements with suppliers.
• Ensure lifecycle quality for products, including validation and post-market surveillance.
• Mentor QA staff and drive continuous quality improvements.
• Present quality metrics to senior management and liaison with regulators.

Skills

Leadership

Quality Assurance

GMP/GDP knowledge

Audits & inspections

Education

Bachelor's or Master's in Pharmacy, Chemistry, Biology

Job description

About the Role

Our client, a prominent pharmaceutical company dedicated to advancing healthcare, is seeking a highly experienced and strategic Senior Pharmaceutical Quality Assurance Manager to lead their QA operations in Vereeniging . This leadership position is responsible for overseeing and implementing the company's quality management systems to ensure compliance with all relevant regulatory standards, including GMP, GDP, and ISO. You will play a critical role in maintaining the integrity and quality of our client's pharmaceutical products throughout their lifecycle. The ideal candidate will possess strong leadership capabilities, extensive knowledge of pharmaceutical quality assurance principles, and a proven track record of successfully managing quality operations. We are looking for a dynamic individual who can drive continuous improvement, foster a quality-centric culture, and ensure the highest standards of product safety and efficacy. This role offers a significant opportunity to shape the quality landscape of a growing pharmaceutical organization and make a profound impact on patient safety.

Key Responsibilities

• Develop, implement, and maintain a comprehensive Quality Management System (QMS) in accordance with GMP, GDP, and other relevant regulatory requirements.
• Oversee all QA activities, including batch record review and release, deviation management, change control, CAPA management, and complaint handling.
• Lead and participate in internal and external audits, including regulatory inspections and supplier audits.
• Ensure compliance with all applicable local and international pharmaceutical regulations.
• Develop and manage quality agreements with contract manufacturers and suppliers.
• Provide quality oversight for product lifecycle management, including validation, stability programs, and post-market surveillance.
• Train and mentor QA personnel, fostering a high-performing team.
• Drive continuous improvement initiatives to enhance quality systems and processes.
• Prepare and present quality metrics and reports to senior management.
• Act as a key point of contact for regulatory agencies on quality-related matters.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• A minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance.
• Extensive knowledge of GMP, GDP, and regulatory requirements (e.g., FDA, EMA, SAHPRA).
• Proven experience in managing QMS, conducting audits, and leading regulatory inspections.
• Strong leadership and people management skills, with the ability to motivate and develop teams.
• Excellent analytical, problem-solving, and decision-making abilities.
• Proficiency in quality risk management principles.
• Strong written and verbal communication skills, with the ability to effectively communicate with all levels of the organization and external stakeholders.
• Experience with validation processes and lifecycle management.
• Ability to work effectively in a fast-paced and demanding environment.

Benefits

• Our client offers a highly attractive salary package, commensurate with experience and leadership responsibilities, plus performance bonuses.
• Comprehensive medical coverage, a generous pension fund, and substantial paid leave are provided.
• Significant opportunities for professional development, including leadership training, specialized QA courses, and international conference participation.
• The work environment in Vereeniging is dynamic and collaborative, focused on achieving and maintaining the highest quality standards.
• Contribute to a critical function ensuring patient safety and product integrity, with ample room for career advancement within a leading pharmaceutical company.
• A supportive and employee-centric culture is a hallmark of our organization.