Senior QA Leader – Pharma Quality & QMS, Great Benefits

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

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.