Director of Pharmaceutical Quality Assurance

Placements24; Durban; Hybrid; ZAR 1,800,000 - 2,600,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

Retirement plan

Job summary

Placements24 in Durban, KwaZulu-Natal, seeks a Director of Pharmaceutical Quality Assurance to lead quality operations and ensure regulatory compliance across manufacturing and development sites.

You will build and maintain robust QMS, drive continuous improvement, and lead a team of QA professionals. The role requires deep cGMP knowledge, regulatory experience, and strong leadership to safeguard product integrity and patient safety.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related field.
• 10+ years progressive QA experience in pharma with 3–5 years in leadership.
• Extensive knowledge of cGMP, ICH guidelines, and QA standards.
• Proven experience managing regulatory inspections and audits.
• Strong leadership, decision-making, and communication skills.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) per global regs (FDA, EMA, SAHPRA).
• Lead QA team, fostering development and high performance.
• Oversee batch record review, deviations, CAPA, change control, audits.
• Ensure cGMP compliance across operations.
• Manage regulatory inspections and health authority audits.
• Develop quality training programs and monitor KPIs.
• Act as primary QA contact for regulators and partners.
• Conduct risk assessments and mitigation for quality issues.
• Stay updated on regulatory landscape and best practices.

Skills

Quality Assurance

Regulatory inspections

Leadership

Risk management

Education

Pharmacy degree

Tools

QMS software

Job description

About the Role

Our client, a prominent global pharmaceutical company, is seeking an accomplished and strategic Director of Pharmaceutical Quality Assurance to oversee quality operations in **Durban, KwaZulu-Natal**. This senior leadership role is responsible for establishing and maintaining robust quality systems that ensure compliance with regulatory standards and safeguard product integrity. The Director will lead a team of QA professionals, driving a culture of continuous improvement and operational excellence. The position requires a deep understanding of cGMP, regulatory affairs, and quality risk management principles. You will be instrumental in shaping the quality strategy for our client's manufacturing and development sites, ensuring the highest standards are met across all operations. The ideal candidate possesses strong leadership capabilities, exceptional analytical skills, and a proactive approach to quality management. This is a critical role in **Durban, KwaZulu-Natal**, ensuring that our client's life-saving medicines meet the stringent quality and safety requirements expected by patients and regulators worldwide. Your expertise will be key to upholding our client's reputation for quality and reliability.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with global regulatory requirements (e.g., FDA, EMA, SAHPRA).
• Lead and mentor the Quality Assurance team, fostering professional development and high performance.
• Oversee all QA activities, including batch record review, deviation management, CAPA implementation, change control, and internal/external audits.
• Ensure compliance with Current Good Manufacturing Practices (cGMP) across all relevant operations.
• Manage regulatory inspections and audits from health authorities, ensuring successful outcomes.
• Develop and execute quality training programs for relevant personnel.
• Monitor key quality metrics and drive continuous improvement initiatives.
• Act as the primary QA contact for regulatory agencies and key business partners.
• Conduct risk assessments and implement mitigation strategies for quality-related issues.
• Stay updated on evolving regulatory landscapes and industry best practices.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• 10+ years of progressive experience in Quality Assurance within the pharmaceutical industry, with at least 3-5 years in a leadership role.
• Extensive knowledge of cGMP regulations, ICH guidelines, and other relevant quality standards.
• Proven experience in managing regulatory inspections and audits.
• Strong leadership, team management, and decision-making skills.
• Excellent analytical, problem-solving, and organizational abilities.
• Effective communication and interpersonal skills, with the ability to influence stakeholders at all levels.
• Experience with quality risk management and continuous improvement methodologies (e.g., Lean, Six Sigma) is highly desirable.
• Ability to travel as required for audits and meetings.
• A strong commitment to quality, compliance, and patient safety.

Benefits

Our client offers a highly competitive salary and a comprehensive benefits package, including extensive health, dental, and vision coverage, life insurance, and a robust retirement savings plan. We provide ample opportunities for professional growth and development, including leadership training, conference attendance, and career advancement paths. The position is based in our modern facilities in **Durban, KwaZulu-Natal**, offering a stimulating work environment. We are dedicated to fostering a diverse and inclusive culture where innovation and collaboration are encouraged. This role presents a significant opportunity to make a lasting impact on the quality and accessibility of medicines globally. Details regarding specific compensation and benefits will be discussed during the interview process.