Pharmaceutical Quality Assurance Manager

Placements24; Richards Bay; Hybrid; ZAR 1,000,000 - 1,500,000; Full time

Benefits offered by this job

Executive bonus

Medical insurance

Retirement plan

Relocation assistance

Hybrid work

Professional growth

Job summary

Placements24 is seeking a Pharmaceutical Quality Assurance Manager in Richards Bay, KwaZulu-Natal. The role combines on-site oversight with hybrid flexibility to lead QA systems across the manufacturing process.

The ideal candidate will have a Master''s degree, 8+ years in QA with 3+ in management, and deep GMP knowledge. You will mentor the QA team, manage audits, CAPA, and supplier qualification, ensuring product quality and regulatory compliance.

Qualifications

• Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• 8+ years in QA in pharma with at least 3 years in management.
• Strong knowledge of GMP (FDA/EU) and regulatory standards.

Responsibilities

• Develop and maintain the Quality Management System (QMS) in compliance with cGMP, ICH, and other regulatory guidelines.
• Oversee QA activities: batch review, deviation management, change control, and CAPA implementation.
• Conduct internal audits and participate in external audits by regulatory agencies and customers.
• Manage and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement.
• Ensure that all pharmaceutical products manufactured meet established quality standards and specifications.
• Review and approve validation protocols and reports (process, cleaning, equipment, analytical methods).
• Manage supplier qualification and monitoring programs.
• Oversee the handling of customer complaints and product quality issues.
• Stay up-to-date with evolving regulatory requirements and industry best practices.
• Lead continuous improvement initiatives within the QA department and manufacturing operations.

Skills

Leadership

Quality Assurance

GMP knowledge

Audits

CAPA

Regulatory compliance

Vendor qualification

Risk management

Communication

Education

Master's degree in Pharmacy, Chemistry, Biology, or related field

Tools

QMS software

Job description

About the Role

Our client, a dynamic and growing pharmaceutical manufacturing company, is seeking an experienced and meticulous Pharmaceutical Quality Assurance Manager to oversee their quality systems and ensure compliance with regulatory standards. This role is based in our facilities located in Richards Bay, KwaZulu-Natal. The position requires a combination of on-site presence for critical quality operations and potential for hybrid flexibility. You will be responsible for developing, implementing, and maintaining robust quality assurance programs that cover all aspects of pharmaceutical production, from raw material sourcing to finished product release. This is a leadership role with significant impact, requiring a deep understanding of GMP, regulatory affairs, and quality management principles within the pharmaceutical industry. The ideal candidate will possess strong leadership skills, a keen eye for detail, and a commitment to upholding the highest standards of product quality and patient safety. The hybrid model balances essential on-site oversight with administrative flexibility.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with cGMP, ICH, and other relevant regulatory guidelines.
• Oversee all QA activities, including batch record review and release, deviation management, change control, and CAPA implementation.
• Conduct internal audits and participate in external audits by regulatory agencies and customers.
• Manage and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement.
• Ensure that all pharmaceutical products manufactured meet established quality standards and specifications.
• Review and approve validation protocols and reports (process, cleaning, equipment, analytical methods).
• Manage supplier qualification and monitoring programs.
• Oversee the handling of customer complaints and product quality issues.
• Stay up-to-date with evolving regulatory requirements and industry best practices.
• Lead continuous improvement initiatives within the QA department and manufacturing operations.

Requirements

• Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry, with at least 3 years in a management role.
• Extensive knowledge of GMP regulations (e.g., FDA 21 CFR Parts 210/211, EU GMP).
• Proven experience in establishing and managing Quality Management Systems.
• Strong understanding of pharmaceutical manufacturing processes, quality control, and analytical testing.
• Excellent leadership, communication, and interpersonal skills.
• Demonstrated ability to manage audits (internal and external) and regulatory inspections.
• Proficiency in risk management principles and tools.
• Experience in the Richards Bay, KwaZulu-Natal region or with local regulatory bodies is a plus.
• Strong problem-solving and decision-making capabilities.

Benefits

• Competitive annual salary of ZAR .
• Executive leadership bonus program.
• Comprehensive medical, dental, and vision insurance.
• Generous retirement plan with company matching.
• Relocation assistance may be available.
• Opportunities for professional growth and certifications.
• Hybrid work flexibility from our Richards Bay, KwaZulu-Natal location.
• Lead a critical function in a growing pharmaceutical manufacturing operation.