Principal Pharmaceutical Quality Assurance Manager

Placements24; Rustenburg; Hybrid; ZAR 1,000,000 - 1,800,000; Full time

Benefits offered by this job

Executive salary and bonus

Medical, dental, and vision coverage

Retirement savings with employer match

Paid vacation, sick leave, holidays

Professional development funding

Remote-friendly environment

Job summary

Placements24 is seeking a Senior Principal Pharmaceutical Quality Assurance Manager to lead global QA activities from Rustenburg, North West. You will shape the QMS, oversee audits, CAPA, supplier engagements, and regulatory inspections.

The role requires a PhD or MSc in a related field, 10+ years in pharmaceutical QA/QC, and proven remote team leadership. You will drive risk-based decisions and continuous improvement across sites and functions.

Qualifications

• Master's or PhD in Pharmacy, Chemistry, Biology, or related field.
• 10+ years in pharmaceutical QA/QC with senior management experience.
• Extensive GMP/GLP knowledge and global regulatory requirements.
• Experience managing regulatory inspections and health authority responses.
• Expertise in developing and implementing Quality Management Systems (QMS).
• Strong leadership, project management, and decision-making skills.
• Analytical, problem-solving, and interpersonal communication skills.
• Auditing internal operations and external vendors/CMOs.
• Ability to manage remote teams across dispersed sites.
• Willing to work remotely from Rustenburg with occasional site visits.

Responsibilities

• Develop and maintain Quality Management Systems per ICH and regulatory standards.
• Oversee batch record review, deviation management, CAPA, and change control.
• Lead audits of vendors and manufacturing sites; support regulatory inspections.
• Manage supplier/CMO qualification and ongoing monitoring.
• Provide QA training; drive continuous improvement and risk-based decisions.

Skills

GMP knowledge

GLP knowledge

Regulatory inspections experience

Quality Management Systems (QMS)

Leadership

Project management

Analytical skills

Auditing (internal/external)

Remote team management

Education

Master's or PhD in Pharmacy/ Chemistry/ Biology

Job description

About the Role

Our client is a distinguished global pharmaceutical organization renowned for its unwavering commitment to quality and compliance. We are seeking a highly experienced and strategic Principal Pharmaceutical Quality Assurance Manager to join our esteemed team, contributing remotely from Rustenburg, North West . This senior leadership position is integral to ensuring that all pharmaceutical products manufactured and distributed meet the highest standards of quality, safety, and efficacy. The successful candidate will be responsible for developing, implementing, and maintaining robust quality management systems that align with global regulatory requirements. This role demands a deep understanding of GMP, regulatory affairs, and a proactive approach to quality risk management. The ideal candidate will provide expert guidance and leadership across various departments, driving a culture of continuous improvement and compliance. Joining our client means becoming part of a team dedicated to making a significant difference in public health through pharmaceutical excellence. This role offers an unparalleled opportunity for influence and impact within the pharmaceutical quality landscape.

Key Responsibilities

Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with ICH guidelines and relevant regulatory standards (e.g., FDA, EMA, SAHPRA). Oversee all aspects of pharmaceutical quality assurance, including batch record review, deviation management, CAPA implementation, and change control. Conduct internal and external audits (vendor qualification, manufacturing sites) to ensure compliance and identify areas for improvement. Lead regulatory inspections by health authorities, ensuring successful outcomes and timely responses to any findings. Manage the qualification and ongoing monitoring of suppliers and contract manufacturing organizations (CMOs). Develop and deliver quality training programs to relevant personnel across the organization. Act as a key subject matter expert on quality and regulatory compliance matters. Lead cross-functional teams to address quality issues and implement corrective and preventive actions effectively. Monitor and report on key quality metrics and performance indicators to senior management. Champion a strong quality culture throughout the organization, promoting continuous improvement and risk-based decision-making.

Requirements

Master's or Ph.D. degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. A minimum of 10 years of progressive experience in pharmaceutical Quality Assurance and Quality Control, with a significant portion in management roles. Extensive knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant global regulatory requirements. Proven experience in managing regulatory inspections and successful responses to health authority inquiries. Demonstrated expertise in developing and implementing Quality Management Systems (QMS). Strong leadership, project management, and decision-making skills. Excellent analytical, problem-solving, and interpersonal communication skills. Experience in auditing internal operations and external vendors/CMOs. Ability to effectively manage remote teams and collaborate across geographically dispersed sites. Understanding of pharmaceutical product lifecycle and associated quality considerations. Residing in or willing to work remotely within proximity to Rustenburg, North West for occasional site visits.

Benefits

Our client offers a highly competitive executive salary and bonus structure, reflecting the seniority of this role. A comprehensive benefits package includes premium medical, dental, and vision coverage, along with a generous retirement savings plan with employer matching. Employees receive ample paid vacation, sick leave, and holidays. We invest in our employees' growth through professional development opportunities, including funding for certifications, advanced training, and attendance at international conferences. The company fosters a dynamic and inclusive remote work environment, emphasizing work-life balance and employee well-being. Access to cutting-edge virtual collaboration tools and resources is provided. Potential for international travel for audits and conferences. Our client is committed to equal opportunities and fosters a culture of respect and innovation.