Senior Quality Assurance Manager - Pharmaceuticals

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

Benefits offered by this job

Competitive salary

Health and wellness benefits

Retirement annuity

Performance-based bonuses

Job summary

Placements24 in Paarl, a leading pharmaceutical company, seeks a Senior Quality Assurance Manager to lead the QA function, maintain the QMS, ensure GMP/ICH compliance, and drive improvements across the site.

The role focuses on supervising the QA team, overseeing batch release review, deviations, CAPA, audits, and interactions with regulators such as FDA and SAHPRA, with a view to protecting product quality and patient safety.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related life science field.
• Master’s degree is advantageous.
• Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of GMP regulations, ICH guidelines, and regulatory submission processes.
• Proven experience in managing and leading a QA team.
• Strong understanding of pharmaceutical manufacturing processes and quality control.
• Excellent analytical, problem-solving, and decision‑making skills.
• Proficiency in quality management software and tools.
• Exceptional communication, interpersonal, and report‑writing skills.
• Demonstrated ability to implement and improve quality systems.
• Experience with regulatory agency inspections (e.g., FDA, SAHPRA).

Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS).
• Ensure compliance with GMP and relevant pharmaceutical regulations.
• Lead and manage the Quality Assurance team, providing guidance and development.
• Oversee quality activities including batch record review, deviation management, and CAPA.
• Conduct internal audits and support external regulatory inspections and audits.
• Manage supplier qualification and quality agreements.
• Review and approve product release documentation.
• Investigate product complaints and OOS results.
• Champion a quality-focused culture across the organization.
• Stay abreast of evolving regulatory requirements and industry best practices.

Skills

Leadership

Quality Assurance

Regulatory compliance

GMP/ICH knowledge

Quality systems

Auditing

Regulatory inspections

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related life science field

Master's degree is advantageous

Tools

Quality management software

Job description

About the Role

Our client, a reputable pharmaceutical company located in Paarl , is seeking a highly experienced and dedicated Senior Quality Assurance Manager. This leadership role is crucial for overseeing and maintaining the company's Quality Management System (QMS) to ensure compliance with all regulatory requirements (e.g., GMP, FDA, SAHPRA). The ideal candidate will possess extensive knowledge of pharmaceutical quality assurance, strong analytical skills, and proven leadership capabilities. You will be responsible for leading the QA team, driving continuous improvement initiatives, and ensuring the integrity and safety of pharmaceutical products. This is a key strategic position within the organization.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS).
• Ensure compliance with Good Manufacturing Practices (GMP) and relevant pharmaceutical regulations.
• Lead and manage the Quality Assurance team, providing guidance and professional development.
• Oversee all quality-related activities, including batch record review, deviation management, and CAPA implementation.
• Conduct internal audits and support external regulatory inspections and audits.
• Manage supplier qualification and quality agreements.
• Review and approve product release documentation.
• Investigate product complaints and out-of-specification (OOS) results.
• Champion a quality-focused culture throughout the organization.
• Stay abreast of evolving regulatory requirements and industry best practices.

Requirements

• A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• A Master's degree is advantageous.
• Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of GMP regulations, ICH guidelines, and regulatory submission processes.
• Proven experience in managing and leading a QA team.
• Strong understanding of pharmaceutical manufacturing processes and quality control.
• Excellent analytical, problem-solving, and decision‑making skills.
• Proficiency in quality management software and tools.
• Exceptional communication, interpersonal, and report‑writing skills.
• Demonstrated ability to implement and improve quality systems.
• Experience with regulatory agency inspections (e.g., FDA, SAHPRA).

Benefits

Our client offers a highly competitive salary, comprehensive health and wellness benefits, a retirement annuity, and performance-based bonuses. This role is based at our state‑of‑the‑art facility in Paarl , Western Cape. Our client is committed to fostering a culture of excellence and provides significant opportunities for career advancement and professional growth within the pharmaceutical sector. Join a leading organization dedicated to improving global health.