Quality Assurance Manager - Pharmaceutical Manufacturing

Placements24; Durban; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Competitive salary with medical and (d

Dental coverage

Pension scheme

Performance-based bonuses

Professional development & conference

Collaborative and ethically driven环境

Travel assistance & wellness programs

Paid annual leave

Job summary

Placements24 represents a leading pharmaceutical manufacturer seeking an experienced Quality Assurance Manager to lead QA operations in Durban. This senior role focuses on establishing and maintaining the QMS, ensuring GMP and regulatory compliance, and driving continuous improvement across all departments.

Ideal candidates will have 10+ years in QA within pharma, with 5+ years in management, strong leadership, and deep knowledge of regulatory submissions and inspections.

Qualifications

• Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 10 years in Quality Assurance within the pharmaceutical industry, with at least 5 years in a management or supervisory role.
• Extensive knowledge of GMP, ICH guidelines, and regulatory submission requirements.
• Proven experience in managing regulatory inspections (e.g., FDA, EMA, SAHPRA).
• Strong understanding of pharmaceutical manufacturing processes, analytical testing, and quality control methodologies.
• Excellent leadership, communication, problem-solving, and decision-making skills.
• Demonstrated ability to build and lead effective teams.
• Experience with quality risk management principles.
• Proficiency in using quality management software and tools.
• Adaptability to a fast-paced and evolving regulatory environment.
• Must have legal authorization to work in Durban , KwaZulu-Natal.

Responsibilities

• Develop, implement, and maintain a comprehensive Quality Management System (QMS) compliant with GMP, GDP, and relevant international standards.
• Oversee all aspects of quality assurance, including quality control, batch release, deviation management, change control, and CAPA systems.
• Lead and manage internal and external audits (regulatory inspections, customer audits, supplier audits).
• Ensure compliance with all applicable regulatory requirements and guidelines pertaining to pharmaceutical manufacturing.
• Develop and execute validation master plans and oversee validation activities for manufacturing processes, equipment, and analytical methods.
• Manage the investigation of quality incidents, root cause analysis, and implementation of corrective and preventive actions.
• Train and mentor QA staff and other personnel on quality standards, procedures, and regulatory requirements.
• Monitor and report on key quality performance indicators (KPIs) to senior management.
• Collaborate with cross-functional teams, including production, R&D, and regulatory affairs, to ensure quality is integrated throughout the product lifecycle.
• Stay updated on evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.

Skills

Leadership

Strategic thinking

Quality mindset

Problem-solving

Decision-making

Team building

Education

Master's degree or PhD in Pharmacy, Chemistry, Biology, or related life science

Tools

Quality Management Software

Job description

About the Role

Our client, a leading pharmaceutical manufacturer, is seeking an experienced and meticulous Quality Assurance Manager to lead their QA operations in Durban . This senior position is responsible for establishing, implementing, and maintaining the company's quality management system, ensuring compliance with all regulatory requirements, including GMP, FDA, and local health authority standards. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes and a strong commitment to upholding the highest quality standards. You will be instrumental in developing quality strategies, managing audits, and driving continuous improvement initiatives across all departments. This is a critical role that ensures the safety, efficacy, and integrity of the company's pharmaceutical products. We are looking for a strategic thinker with exceptional leadership skills and a proven ability to build and develop high-performing teams. This is an excellent career opportunity to contribute to a globally recognized organization committed to improving patient health through innovative medicines, based in the beautiful coastal city of Durban .

Key Responsibilities

• Develop, implement, and maintain a comprehensive Quality Management System (QMS) compliant with GMP, GDP, and relevant international standards.
• Oversee all aspects of quality assurance, including quality control, batch release, deviation management, change control, and CAPA systems.
• Lead and manage internal and external audits (regulatory inspections, customer audits, supplier audits).
• Ensure compliance with all applicable regulatory requirements and guidelines pertaining to pharmaceutical manufacturing.
• Develop and execute validation master plans and oversee validation activities for manufacturing processes, equipment, and analytical methods.
• Manage the investigation of quality incidents, root cause analysis, and implementation of corrective and preventive actions.
• Train and mentor QA staff and other personnel on quality standards, procedures, and regulatory requirements.
• Monitor and report on key quality performance indicators (KPIs) to senior management.
• Collaborate with cross-functional teams, including production, R&D, and regulatory affairs, to ensure quality is integrated throughout the product lifecycle.
• Stay updated on evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.

Requirements

• Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 10 years of experience in Quality Assurance within the pharmaceutical industry, with at least 5 years in a management or supervisory role.
• Extensive knowledge of GMP, ICH guidelines, and regulatory submission requirements.
• Proven experience in managing regulatory inspections (e.g., FDA, EMA, SAHPRA).
• Strong understanding of pharmaceutical manufacturing processes, analytical testing, and quality control methodologies.
• Excellent leadership, communication, problem-solving, and decision-making skills.
• Demonstrated ability to build and lead effective teams.
• Experience with quality risk management principles.
• Proficiency in using quality management software and tools.
• Adaptability to a fast-paced and evolving regulatory environment.
• Must have legal authorization to work in Durban , KwaZulu-Natal.

Benefits

• Our client offers a highly competitive salary commensurate with experience, along with excellent benefits including comprehensive medical and dental coverage, a generous pension scheme, and performance-based bonuses.
• Employees will have significant opportunities for professional development and career advancement, including attendance at international conferences and specialized training.
• The company fosters a collaborative and ethically driven work environment in Durban .
• Additional benefits include subsidized travel assistance, on-site wellness programs, and ample paid annual leave.