Pharmaceutical Quality Assurance Manager

Placements24; Richards Bay; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Executive leadership bonus program

Health insurance (medical, dental, and

Retirement plan with company matching

Relocation assistance may be available

Hybrid work flexibility

Job summary

Placements24 seeks an experienced Pharmaceutical Quality Assurance Manager to lead QA operations at our Richards Bay facility. The role combines on-site oversight with hybrid flexibility, overseeing QMS, batch release, deviations, CAPA, audits, and supplier qualification to uphold high product quality and patient safety.

You will guide a QA team, ensure regulatory compliance, and drive continuous improvement in manufacturing processes and analytical testing within a GMP framework.

Qualifications

• Proven leadership of QA teams in pharmaceutical manufacturing.
• Extensive knowledge of GMP regulations and regulatory expectations.
• Experience establishing and maintaining QMS across manufacturing.
• Strong auditing and CAPA management capabilities.
• Risk management and supplier qualification experience.

Responsibilities

• Develop, implement, and maintain a compliant QMS aligned with cGMP/ICH.
• Oversee QA activities including batch review, release, deviations and CAPA.
• Lead internal and regulatory audits and host external inspections.
• Mentor QA team and drive continuous quality improvements.
• Ensure products meet established quality specs and safety standards.
• Review and approve validation protocols and reports.
• Manage supplier qualification and monitoring programs.
• Address customer quality issues and complaints effectively.
• Stay updated on regulatory changes and best practices.
• Lead continuous improvement initiatives within QA and operations.

Skills

Leadership

GMP

Quality management

Audits

Regulatory knowledge

Problem solving

Education

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

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.