Senior Pharmaceutical Quality Assurance Manager

Placements24; Bloemfontein; On-site; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Retirement fund

Professional development

Job summary

Placements24 invites applications for a Senior Pharmaceutical Quality Assurance Manager to lead QA operations in Bloemfontein, Free State, SA. You will establish and maintain the Quality Management System to ensure GMP compliance and patient safety across all products.

The role requires eight+ years in pharmaceutical QA with at least three in management, MSc or PhD in a related field, and proven audit, CAPA, and risk-management experience.

Qualifications

• Proven experience leading QA teams and initiatives.
• Strong knowledge of GMP, ICH, and regulatory requirements.
• Strategic thinker with excellent analytical and problem-solving skills.

Responsibilities

• Develop and maintain the QMS in line with GMP and relevant regulations.
• Lead and develop the QA team, including coaching and performance management.
• Oversee internal and external audits and ensure timely closure of findings.
• Manage deviations and CAPA processes with robust root-cause analysis.
• Review and approve critical QA documents (batch records, validation protocols, SOPs).
• Ensure regulatory compliance across product lifecycle and with company policies.
• Collaborate with Production, QC, and R&D to implement improvements.
• Monitor quality metrics and report to senior management.
• Drive continuous improvement to enhance product quality and process efficiency.
• Act as primary point of contact for regulatory inspections and audits.

Skills

Quality Assurance

Quality Leadership

Audit Management

CAPA Management

Process Validation

Education

MSc or PhD in Pharmaceutical Sciences/related field

Job description

About the Role

Our client, a renowned pharmaceutical manufacturer with a commitment to excellence, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to lead their QA operations in Bloemfontein, Free State, ZA . This pivotal role is responsible for establishing, implementing, and maintaining the overall Quality Management System (QMS) to ensure compliance with all relevant national and international regulatory standards, including GMP. You will lead a team of QA professionals, oversee audits, manage deviations, and drive continuous improvement initiatives across the site. The ideal candidate will possess a strong understanding of pharmaceutical quality systems, regulatory requirements, and a proven track record in quality leadership. This position requires a strategic thinker with excellent analytical and problem-solving skills, dedicated to upholding the highest standards of product quality and patient safety. You will play a critical role in maintaining our client's reputation for producing safe and effective pharmaceutical products.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with GMP and other applicable regulations.
• Lead and manage the Quality Assurance team, providing guidance, training, and performance management.
• Oversee internal and external audits (supplier audits, regulatory inspections), ensuring timely closure of findings.
• Manage the deviation and CAPA (Corrective and Preventive Action) systems, ensuring thorough investigations and effective root cause analysis.
• Review and approve critical quality documents, including batch records, validation protocols, and SOPs.
• Ensure compliance with all regulatory requirements and company policies throughout the product lifecycle.
• Collaborate with other departments (Production, QC, R&D) to address quality issues and implement improvements.
• Monitor key quality metrics and performance indicators, reporting to senior management.
• Lead continuous improvement initiatives to enhance product quality, process efficiency, and compliance.
• Act as the primary point of contact for regulatory inspections and audits.
• Stay current with evolving regulatory landscapes and industry best practices.

Requirements

• MSc or PhD in Pharmaceutical Sciences, Chemistry, Biology, or a related field.
• A minimum of 8 years of progressive experience in pharmaceutical Quality Assurance, with at least 3 years in a management or supervisory role.
• Extensive knowledge of GMP, ICH guidelines, and regulatory requirements (SAHPRA, FDA, EMA).
• Proven experience in developing and managing a comprehensive Quality Management System.
• Demonstrated experience in leading audits, managing deviations, and implementing CAPAs.
• Strong leadership, communication, and interpersonal skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Experience with validation processes (process, cleaning, analytical method) is essential.
• Proficiency in quality risk management principles.
• Ability to work effectively under pressure and manage multiple priorities.

Benefits

Our client offers a highly competitive salary, comprehensive medical aid, and retirement fund benefits. Employees are provided with excellent opportunities for professional development, including advanced training and certifications. This role offers significant career growth potential within a respected and stable pharmaceutical company. You will work in a well-established facility and contribute to the production of high-quality medicines.