Quality Assurance Manager - Pharmaceutical Manufacturing

Placements24; Mbombela (Nelspruit); On-site; ZAR 900,000 - 1,800,000; Full time

Benefits offered by this job

Executive pay

Medical aid

Pension fund

Life insurance

Relocation assistance

Conferences

Annual leave

Wellness program

Leadership role

Tech access

Supportive environment

Career growth

Job summary

Placements24 in Nelspruit, Mpumalanga, seeks an experienced Quality Assurance Manager to lead the QA department, ensuring GMP compliance and regulatory alignment with SAHPRA, FDA, and EMA. You will develop and maintain the QMS, oversee audits, CAPAs, deviations, and drive continuous improvement to safeguard patient safety.

The role requires a Master’s/PhD in a life science, 8+ years in pharma QA, and strong leadership and communication skills.

Qualifications

• Master's degree or PhD in Pharmacy, Chemistry, Microbiology, or a related life science field.
• Minimum of 8 years progressive experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of GMP, ICH guidelines, and regulatory requirements (SAHPRA, FDA, EMA).
• Proven experience in developing and managing a comprehensive Quality Management System.
• Strong leadership, team management, and decision-making skills.
• Excellent analytical, problem-solving, and communication skills.
• Experience in managing regulatory inspections and audits.
• Proficiency in quality risk management principles.
• Ability to interpret complex regulatory documents and implement necessary changes.

Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with GMP and regulatory requirements.
• Lead and manage the Quality Assurance team, providing guidance and professional development.
• Oversee internal and external audits, ensuring readiness and effective resolution of findings.
• Manage deviation investigations, CAPA (Corrective and Preventive Actions), and change control processes.
• Ensure all manufacturing processes and documentation comply with regulatory standards.
• Review and approve batch records, validation protocols, and reports.
• Monitor product quality and implement measures to prevent quality issues.
• Stay abreast of regulatory changes and ensure the QMS remains current.
• Liaise with regulatory authorities and facilitate inspections.
• Promote a quality-focused culture throughout the organization.

Skills

Leadership

Strategic thinking

Analytical

Communication

Regulatory liaison

Education

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

Job description

About the Role

Our client, a reputable pharmaceutical manufacturer located in Nelspruit , Mpumalanga, is seeking an experienced and highly qualified Quality Assurance Manager. This pivotal role involves leading and managing all aspects of the Quality Assurance department to ensure compliance with Good Manufacturing Practices (GMP) and relevant regulatory standards (e.g., SAHPRA, FDA). The ideal candidate will possess extensive knowledge of pharmaceutical quality systems, strong leadership abilities, and a meticulous approach to ensuring product quality and patient safety. You will be responsible for developing, implementing, and maintaining the company's quality management system, overseeing audits, managing deviations, and driving continuous improvement initiatives. This is a senior leadership position offering the chance to significantly impact quality standards within a growing pharmaceutical company in Nelspruit . Our client is dedicated to producing safe and effective medicines and requires a leader who shares this commitment. You will be instrumental in upholding the highest standards of quality and regulatory compliance in a critical industry.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with GMP and regulatory requirements.
• Lead and manage the Quality Assurance team, providing guidance and professional development.
• Oversee internal and external audits, ensuring readiness and effective resolution of findings.
• Manage deviation investigations, CAPA (Corrective and Preventive Actions), and change control processes.
• Ensure all manufacturing processes and documentation comply with regulatory standards.
• Review and approve batch records, validation protocols, and reports.
• Monitor product quality and implement measures to prevent quality issues.
• Stay abreast of regulatory changes and ensure the QMS remains current.
• Liaise with regulatory authorities and facilitate inspections.
• Promote a quality-focused culture throughout the organization.

Requirements

• Master's degree or PhD in Pharmacy, Chemistry, Microbiology, or a related life science field.
• Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of GMP, ICH guidelines, and regulatory requirements (SAHPRA, FDA, EMA).
• Proven experience in developing and managing a comprehensive Quality Management System.
• Strong leadership, team management, and decision-making skills.
• Excellent analytical, problem-solving, and communication skills.
• Experience in managing regulatory inspections and audits.
• Proficiency in quality risk management principles.
• Ability to interpret complex regulatory documents and implement necessary changes.
• Strong documentation and reporting skills.

Benefits

• Highly competitive executive salary and performance-based bonus.
• Comprehensive benefits package including medical aid, pension fund, and life insurance.
• Relocation assistance to Nelspruit .
• Opportunities for international professional development and conferences.
• Generous annual leave and leave incentives.
• Employee wellness programs and occupational health services.
• Leadership role in a critical and impactful industry.
• Access to advanced pharmaceutical manufacturing technology.
• A supportive and professional working environment.
• Long-term career prospects within a growing organization.