Senior Pharmaceutical Quality Assurance Manager

Placements24; Paarl; Hybrid; ZAR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Bonus structure

Medical benefits

Retirement benefits

Career growth opportunities

Job summary

Placements24 in South Africa's Western Cape seeks a Senior Pharmaceutical Quality Assurance Manager in Paarl to lead the QA team and safeguard compliance with GMP, ICH, SAHPRA, FDA and EMA standards. This executive role shapes the QMS, batch release, deviations, CAPAs, audits, and supplier quality, driving excellence and patient safety.

The ideal candidate holds a Master's or PhD in a life science field, 8+ years in pharmaceutical QA, and proven leadership.

Qualifications

• Master's degree or Ph.D. in Pharmacy, Chemistry, or related life science discipline.
• Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of GMP regulations and quality systems.
• Proven experience in managing regulatory inspections and successful audit outcomes.
• Strong leadership, team management, and decision-making skills.
• Excellent understanding of pharmaceutical manufacturing processes and product lifecycle.
• Exceptional analytical, problem-solving, and communication skills.
• Experience in developing and implementing quality policies and procedures.
• Ability to work effectively in a hybrid work environment, contributing both remotely and on-site in Paarl, Western Cape.

Responsibilities

• Develop, implement, and manage the Quality Management System (QMS) in accordance with global regulatory standards (GMP, ICH).
• Oversee QA activities including batch record review, product release, deviations, CAPAs, change control, and risk management.
• Conduct and manage internal audits and support regulatory inspections and customer audits.
• Ensure compliance with SAHPRA, FDA, and EMA guidelines.
• Lead and mentor the QA team, fostering a culture of quality and continuous improvement.
• Review and approve key quality documents such as SOPs, validation protocols, and qualification reports.
• Manage supplier quality agreements and perform supplier audits.
• Investigate quality incidents and implement corrective and preventive actions.

Skills

Leadership

Regulatory knowledge

Quality management

Analytical thinking

Communication skills

Problem solving

Education

Master's degree or Ph.D. in Pharmacy, Chemistry, or related life science

Job description

About the Role

Our client, a distinguished pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to lead their quality systems team. This critical role, located in Paarl, Western Cape , will be responsible for ensuring that all pharmaceutical operations adhere to the highest standards of quality, safety, and regulatory compliance. The manager will oversee the development, implementation, and maintenance of robust quality management systems, including SOPs, change control, deviation management, and internal audits. This is a leadership position offering the chance to significantly impact the company's commitment to excellence in pharmaceutical manufacturing and patient safety. You will be instrumental in upholding our company's reputation for quality and reliability.

Key Responsibilities

• Develop, implement, and manage the company's Quality Management System (QMS) in accordance with global regulatory standards (e.g., GMP, ICH).
• Oversee all QA activities, including batch record review, product release, deviations, CAPAs, change control, and risk management.
• Conduct and manage internal audits and support external regulatory inspections and customer audits.
• Ensure compliance with all applicable regulatory requirements, including SAHPRA, FDA, and EMA guidelines.
• Lead and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement.
• Review and approve key quality-related documents, such as SOPs, validation protocols, and qualification reports.
• Manage supplier quality agreements and perform supplier audits.
• Investigate quality incidents and implement effective corrective and preventive actions.
• Stay abreast of evolving regulatory requirements and industry best practices.
• Report on the performance of the QMS to senior management.

Requirements

• Master's degree or Ph.D. in Pharmacy, Chemistry, or a related life science discipline.
• Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of GMP regulations and quality systems.
• Proven experience in managing regulatory inspections and successful audit outcomes.
• Strong leadership, team management, and decision-making skills.
• Excellent understanding of pharmaceutical manufacturing processes and product lifecycle.
• Exceptional analytical, problem-solving, and communication skills.
• Experience in developing and implementing quality policies and procedures.
• Ability to work effectively in a hybrid work environment, contributing both remotely and on-site in Paarl, Western Cape .

Benefits

This role offers a highly competitive executive salary, a comprehensive bonus structure, excellent medical and retirement benefits, and substantial opportunities for career growth and leadership development. The opportunity to live and work in the beautiful Paarl, Western Cape region, coupled with a flexible hybrid work arrangement, provides an attractive work-life balance. Join a company that is dedicated to quality and committed to the professional development of its employees.