Lead Pharmaceutical Quality Assurance Manager

Placements24; Cape Town; On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Bonuses

Benefits package

Retirement plan

Professional development

Relocation assistance

Job summary

Placements24 in Cape Town is seeking a Lead Pharmaceutical Quality Assurance Manager to oversee quality operations in the Western Cape. This hands-on leadership role requires driving GMP compliance across manufacturing and distribution, and building a robust QMS.

You will lead a QA team, manage deviations, CAPAs, audits, risk assessments, and regulatory inspections, while partnering with Production, R&D and Supply Chain to improve processes and patient safety.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related field.
• 8+ years in pharmaceutical QA/QC with 3+ years in leadership.
• Extensive knowledge of GMP/ICH and regulatory requirements.
• Experience developing and implementing QMS.
• Proven team leadership experience.
• Experience with regulatory inspections and audits.
• Proficiency in quality management software.
• Ability to manage multiple priorities under pressure.

Responsibilities

• Develop, implement, and maintain the company's QMS per GMP/ICH.
• Lead the QA team with guidance, training, and performance management.
• Oversee batch record review, deviations, CAPA, change control, and internal audits.
• Ensure compliance with national and international pharma regulations and guidelines.
• Conduct risk assessments and mitigate to ensure product quality and patient safety.
• Manage external audits from regulators and customers.
• Collaborate with Production, R&D, and Supply Chain to resolve quality issues and drive improvements.
• Review and approve validation protocols and reports for manufacturing processes and equipment.
• Monitor key quality metrics and report overall quality performance.
• Stay updated on evolving regulatory requirements and industry best practices.

Skills

GMP knowledge

QA leadership

Regulatory inspections experience

Risk assessment

Education

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

Tools

Quality management software

Job description

About the Role

Our client, a prominent pharmaceutical organization, is actively seeking an accomplished Lead Pharmaceutical Quality Assurance Manager to oversee quality operations in Cape Town, Western Cape . This pivotal role involves ensuring the highest standards of quality and compliance across all pharmaceutical manufacturing and distribution processes. The ideal candidate will possess a deep understanding of regulatory requirements and a proven ability to implement robust quality management systems. You will lead a dedicated team, fostering a culture of continuous improvement and adherence to Good Manufacturing Practices (GMP). This is a hands‑on leadership position based in our modern facility, offering a significant opportunity to shape the future of pharmaceutical quality in the region. We are looking for a strategic thinker with exceptional leadership skills and a commitment to excellence. The role is critical to maintaining our reputation for producing safe and effective pharmaceutical products. Join us in a vibrant city and contribute to a vital industry that impacts lives daily.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with regulatory standards (e.g., GMP, ICH).
• Lead and manage the Quality Assurance team, providing guidance, training, and performance management.
• Oversee all quality-related activities, including batch record review, deviation investigations, CAPA management, change control, and internal audits.
• Ensure compliance with national and international pharmaceutical regulations and guidelines.
• Conduct risk assessments and implement mitigation strategies to ensure product quality and patient safety.
• Manage external audits from regulatory authorities and customers, ensuring successful outcomes.
• Collaborate with Production, R&D, and Supply Chain departments to resolve quality issues and drive process improvements.
• Review and approve validation protocols and reports for manufacturing processes and equipment.
• Monitor key quality metrics and report on the overall quality performance of the organization.
• Stay updated on evolving regulatory requirements and industry best practices.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• A minimum of 8 years of experience in pharmaceutical Quality Assurance or Quality Control, with at least 3 years in a management or leadership role.
• Extensive knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
• Demonstrated experience in developing and implementing QMS.
• Proven ability to lead and develop a team.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication, interpersonal, and negotiation skills.
• Experience with regulatory inspections and audits is essential.
• Proficiency in quality management software and tools.
• Ability to manage multiple priorities and work effectively under pressure.

Benefits

• Excellent base salary and performance-based bonuses.
• Comprehensive medical, dental, and vision insurance.
• Generous retirement savings plan.
• Opportunities for continuous professional development, including advanced training and conference attendance.
• Relocation assistance may be available for the right candidate.

You will be part of a forward-thinking company that values its employees and fosters a culture of innovation and collaboration.

Contribute to a globally recognized pharmaceutical leader from the beautiful setting of Cape Town .