Senior Pharmaceutical Quality Assurance Manager

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

Benefits offered by this job

Health insurance

Retirement plan

Professional development

Paid time off

Wellness programs

Performance bonuses

Job summary

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Manager in Pietermaritzburg, KwaZulu-Natal. You will uphold GMP/GDP standards, lead QA teams, and drive continuous improvement across QA processes and supplier quality.

You will develop and maintain QMS, oversee audits and regulatory inspections, and collaborate with cross-functional teams to ensure product quality and regulatory compliance.

Qualifications

• 8+ years in pharmaceutical quality assurance with progressive responsibility.
• At least 3 years in a managerial or supervisory role.
• Deep knowledge of GMP, GDP, ICH guidelines and regulatory requirements.
• Experience developing and managing QMS, audits and regulatory inspections.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Develop, implement and maintain QMS aligned with GMP/GDP and regulatory standards.
• Oversee quality control testing and assurance for pharmaceutical products.
• Lead and mentor QA professionals; foster a high-performing team.
• Conduct internal audits and support regulatory inspections.
• Manage deviations, CAPA, change control and investigations.
• Review batch records, validation protocols and documentation.
• Collaborate with R&D, manufacturing and regulatory affairs.
• Stay abreast of evolving regulatory requirements and best practices.
• Manage supplier qualification and quality agreements; present metrics to leadership.

Skills

Leadership

Team management

Analytical thinking

Problem solving

Communication

Regulatory knowledge

Education

Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology

Tools

Quality management software

ERP systems

Job description

About the Role

Our client, a leading entity in the pharmaceutical sector, is seeking to appoint a highly skilled and experienced Senior Pharmaceutical Quality Assurance Manager to join their esteemed team in Pietermaritzburg, KwaZulu-Natal . This pivotal role is instrumental in upholding the highest standards of quality across all pharmaceutical operations, ensuring compliance with national and international regulatory guidelines. The successful candidate will play a critical part in maintaining the integrity and safety of our client's products, fostering a culture of continuous improvement and excellence within the quality assurance department. This is a challenging yet rewarding opportunity for a dedicated professional looking to make a significant impact in a dynamic industry. We are committed to providing a stable and growth-oriented environment for our employees, and this position offers substantial potential for career advancement within a reputable organization.

Key Responsibilities

• Develop, implement, and maintain robust Quality Management Systems (QMS) in line with GMP, GDP, and other relevant regulatory standards.
• Oversee and manage all aspects of quality control testing and assurance processes for pharmaceutical products.
• Lead and mentor a team of quality assurance professionals, fostering a collaborative and high-performing work environment.
• Conduct internal audits and host external regulatory inspections, ensuring prompt and effective resolution of any findings.
• Manage deviation investigations, CAPA implementation, and change control processes to ensure product quality and safety.
• Review and approve batch records, validation protocols, and technical documentation.
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure seamless product lifecycle management.
• Stay abreast of evolving regulatory requirements and industry best practices, ensuring continuous compliance.
• Manage supplier qualification and quality agreements to ensure the integrity of raw materials and components.
• Prepare and present quality metrics and reports to senior management.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 8 years of progressive experience in pharmaceutical quality assurance, with at least 3 years in a managerial or supervisory role.
• In-depth knowledge of GMP, GDP, ICH guidelines, and other relevant pharmaceutical regulations.
• Proven experience in developing and managing QMS, conducting audits, and handling regulatory inspections.
• Strong leadership, team management, and interpersonal skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Proficiency in using quality management software and ERP systems.
• Exceptional communication skills, both written and verbal, with the ability to effectively communicate complex technical information.
• Detail-oriented with a strong commitment to accuracy and quality.

Benefits

Our client offers a competitive remuneration package commensurate with experience and qualifications. In addition to a substantial annual salary, this position includes comprehensive health insurance, retirement savings plan contributions, and opportunities for professional development and continuous learning. Employees benefit from generous paid time off, including annual leave and sick leave, as well as access to wellness programs designed to promote a healthy work-life balance. The company also provides potential for performance-based bonuses and other employee recognition initiatives. Join a supportive and innovative work environment where your contributions are valued and career growth is encouraged. This is an excellent opportunity to advance your career within the pharmaceutical industry in Pietermaritzburg.