Senior Pharmaceutical Quality Assurance Manager

Placements24; Pietermaritzburg; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Competitive salary

Health and retirement benefits

Professional development

Hybrid work options

Job summary

Placements24 seeks an experienced Senior Pharmaceutical Quality Assurance Manager in Pietermaritzburg to lead and strengthen our quality systems, ensuring compliance with SA and international regulations.

You will head a QA team, manage QMS, audits, CAPA, change control, and oversight of batch records, while partnering with R&D, Production and Regulatory Affairs to embed quality across the lifecycle.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, or a related life science field.
• 7–10 years in pharmaceutical QA with at least 3 in a management role.
• In-depth knowledge of GMP, GDP, and relevant SA and international regulations.
• Experience with quality risk management and regulatory inspections.
• Strong leadership, communication, and analytical skills.

Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in compliance with ICH guidelines and regulatory standards.
• Lead and mentor the Quality Assurance team, providing guidance on GMP, GDP, and regulatory compliance.
• Conduct internal audits and oversee external audits from regulatory bodies and clients, ensuring timely resolution of deviations.
• Manage the change control, deviation, and CAPA systems, driving root cause analysis and corrective actions.
• Review and approve batch records, validation protocols, and SOPs, ensuring accuracy and compliance.
• Collaborate with R&D, Production, and Regulatory Affairs to ensure quality is integrated throughout the product lifecycle.

Skills

GMP/GDP knowledge

Regulatory inspections

Leadership

Analytical skills

Attention to detail

Strong communication

Education

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

Job description

About the Role

Our client is seeking an experienced and highly meticulous Senior Pharmaceutical Quality Assurance Manager to oversee and enhance their quality systems in Pietermaritzburg . This pivotal role ensures compliance with national and international pharmaceutical regulations, maintaining the integrity and safety of all manufactured products. You will lead a dedicated QA team, fostering a culture of continuous improvement and regulatory adherence across all operations. This is an excellent opportunity to make a significant impact on product quality and patient safety within a respected pharmaceutical organization committed to innovation and excellence.

Key Responsibilities

• Develop, implement, and maintain robust quality management systems (QMS) in compliance with ICH guidelines and relevant regulatory standards.
• Lead and mentor the Quality Assurance team, providing guidance on GMP, GDP, and regulatory compliance.
• Conduct internal audits and oversee external audits from regulatory bodies and clients, ensuring timely resolution of any identified deviations.
• Manage the change control, deviation, and CAPA (Corrective and Preventive Actions) systems, driving root cause analysis and effective corrective actions.
• Review and approve critical documents, including batch records, validation protocols, and SOPs, ensuring accuracy and compliance.
• Collaborate with R&D, Production, and Regulatory Affairs departments to ensure seamless integration of quality principles throughout the product lifecycle.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, or a related life science field.
• Minimum of 7-10 years of progressive experience in pharmaceutical Quality Assurance, with at least 3 years in a management role.
• In-depth knowledge of Good Manufacturing Practices (GMP) , Good Distribution Practices (GDP), and relevant South African and international pharmaceutical regulations.
• Proven experience with quality risk management and regulatory inspections.
• Strong leadership, communication, and analytical skills, with a keen eye for detail.

Benefits

• Competitive annual salary and performance-based bonuses.
• Comprehensive health, retirement, and insurance benefits package.
• Opportunities for professional development and further training in pharmaceutical quality.
• A dynamic and collaborative work environment with a focus on employee growth.
• Potential for hybrid work arrangements to support work-life balance.