Lead Pharmaceutical Quality Assurance Manager

Placements24; George; On-site; ZAR 450,000 - 750,000; Full time

Benefits offered by this job

Medical aid

Life insurance

Retirement fund

Professional development

Job summary

Placements24 is seeking a Lead Pharmaceutical Quality Assurance Manager in George, Western Cape. This senior role oversees the QMS, QA/QC teams and product quality, ensuring regulatory compliance and patient safety across all production activities.

The role requires extensive GMP/ICH experience, strategic leadership and a proven track record in audits and continuous improvement. Exposure to aseptic processes and regulatory inspections is highly valued.

Qualifications

• 8+ years of progressive experience in pharmaceutical QA/QC.
• Master's or PhD in a related field.
• Experience with GMP, ICH guidelines and regulatory inspections.
• Strong leadership, communication and decision-making skills.
• Authorized to work in George, Western Cape.

Responsibilities

• Develop, implement and manage the Quality Management System (QMS) in line with GMP/ICH and ISO standards.
• Lead QA/QC team, mentor staff and drive a culture of continuous improvement.
• Oversee batch record review, deviations, CAPA, change control and investigations.
• Coordinate internal audits and support regulatory inspections (SAHPRA, FDA).
• Manage supplier quality and product release processes; review validation protocols.

Skills

Leadership

Team management

Analytical thinking

Problem solving

Communication skills

Presentation skills

Education

Master's or Ph.D. in Pharmacy, Chemistry, Biology, or related field

Tools

Quality management software

Job description

About the Role

Our client is seeking an accomplished and detail-oriented Lead Pharmaceutical Quality Assurance Manager to oversee all quality-related operations at their facility in George, Western Cape . This senior leadership position is critical to ensuring compliance with stringent regulatory standards and maintaining the highest levels of product quality and patient safety. The successful candidate will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS). This role requires a strategic thinker with extensive experience in pharmaceutical quality assurance and a proven ability to lead and mentor a team. You will play a key role in shaping quality strategies, driving continuous improvement initiatives, and ensuring the integrity of all pharmaceutical products manufactured. This position is essential for maintaining our client's reputation for excellence and reliability within the pharmaceutical industry. The role is based at our George, Western Cape facility.

Key Responsibilities

Develop, implement, and manage the company's Quality Management System (QMS) in accordance with international regulatory standards (e.g., GMP, ISO). Lead and mentor the Quality Assurance team, fostering a culture of quality consciousness and continuous improvement. Oversee all quality control activities, including batch record review, deviation investigations, and CAPA implementation. Conduct internal audits and support external regulatory inspections (e.g., SAHPRA, FDA). Ensure compliance with all relevant pharmaceutical manufacturing regulations and guidelines. Manage product release processes, ensuring all quality criteria are met before product distribution. Review and approve validation protocols and reports for manufacturing processes and equipment. Collaborate with R&D, Manufacturing, and Regulatory Affairs departments to ensure seamless integration of quality standards. Manage supplier quality agreements and conduct supplier audits. Investigate customer complaints and product quality issues, implementing corrective and preventive actions. Stay updated on regulatory changes and industry best practices in pharmaceutical quality assurance. Prepare and present quality metrics and reports to senior management.

Requirements

Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field. Minimum of 8 years of progressive experience in pharmaceutical Quality Assurance/Quality Control. Extensive knowledge of GMP regulations, ICH guidelines, and pharmaceutical manufacturing processes. Demonstrated experience in managing and leading a QA/QC team. Proven ability to develop and implement effective Quality Management Systems. Strong experience with regulatory inspections and audits (internal and external). Excellent analytical, problem-solving, and decision-making skills. Exceptional communication, interpersonal, and presentation skills. Proficiency in quality management software and tools. Experience in aseptic processing and sterile manufacturing is a significant advantage. Commitment to maintaining the highest quality standards in a pharmaceutical environment. Must be authorized to work in George, Western Cape .

Benefits

This position offers a highly competitive salary, a comprehensive benefits package including medical aid, life insurance, and a retirement fund. Opportunities for professional development and continuous learning are actively encouraged, with support for attending industry conferences and training. Our client provides a challenging yet rewarding work environment with significant opportunities for career advancement. Employees are part of a dedicated team focused on delivering excellence in pharmaceutical quality. We value our employees and strive to create a work-life balance that supports personal and professional growth.