Lead Pharmaceutical Quality Assurance Manager

Our client, a dynamic and growing pharmaceutical company, is seeking an experienced and highly skilled Lead Pharmaceutical Quality Assurance Manager to oversee and enhance their quality management systems. This critical role, based in Rustenburg, North West , requires a strategic thinker with a deep understanding of pharmaceutical manufacturing, regulatory compliance, and quality control. You will lead a team of QA professionals, ensuring that all products meet the highest standards of safety, efficacy, and quality from development through to market release.

The successful candidate will be instrumental in driving continuous improvement initiatives and maintaining the company's reputation for excellence. This is an on-site position demanding presence and leadership within our Rustenburg facility.

Develop, implement, and maintain comprehensive Quality Assurance (QA) programs and systems in compliance with GMP, regulatory requirements, and company standards. Lead and manage the QA team, providing guidance, mentorship, and performance feedback. Oversee all aspects of the quality control process, including batch record review, product release, deviation management, change control, and CAPA investigations. Conduct internal audits and support external regulatory inspections (e.g., SAHPRA, FDA, EMA).

Ensure that all manufacturing and laboratory operations comply with relevant quality standards and regulations. Manage the supplier qualification program and conduct vendor audits. Develop and deliver quality training programs for personnel involved in pharmaceutical manufacturing and development. Investigate product quality complaints and implement corrective and preventive actions. Monitor key quality performance indicators (KPIs) and implement strategies for continuous improvement. Stay current with evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.

Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field. Minimum of 7 years of progressive experience in pharmaceutical Quality Assurance, with at least 3 years in a management or leadership role. In-depth knowledge of GMP regulations, including SAHPRA, FDA, and EMA guidelines. Proven experience in leading successful regulatory inspections and audits. Strong understanding of pharmaceutical manufacturing processes, quality control testing, and validation principles.

Excellent leadership, team management, and interpersonal skills. Strong analytical and problem-solving abilities, with a meticulous attention to detail. Effective communication skills, both written and verbal, for reporting and presenting findings. Experience with quality management software (e.g., LIMS, QMS) is highly desirable. Demonstrated ability to drive change and implement robust quality systems within a pharmaceutical setting in Rustenburg, North West .

Our client offers a competitive remuneration package, comprehensive medical aid, provident fund, performance bonuses, and extensive opportunities for professional growth and career advancement. We provide a challenging yet rewarding work environment where your expertise is valued. Join a company committed to producing high-quality pharmaceuticals and making a significant impact on public health. This role is based at our state-of-the-art facility in Rustenburg, North West .