Senior Pharmaceutical Quality Assurance Manager

Placements24; États-Unis; À distance; USD 59 000 - 101 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Medical aid

Retirement annuity

Generous leave

Résumé du poste

Placements24 is assisting a leading pharmaceutical organization in appointing a Senior Pharmaceutical Quality Assurance Manager to oversee QA operations in Klerksdorp, North West. The role emphasizes GMP compliance, QMS leadership, and regulatory readiness across SAHPRA, FDA, and EMA expectations.

You will lead a QA team, manage deviations, CAPA, audits, and inspections, and drive continuous improvement through KPIs.

Qualifications

• 8+ years in Pharmaceutical Quality Assurance with 3+ years in a leadership role.
• In-depth knowledge of GMP, ISO standards, SAHPRA/FDA/EMA requirements.
• Proven ability to manage a QMS including deviations, changes, CAPA, audits.
• Experience hosting regulatory inspections and customer audits.

Responsabilités

• Develop and maintain QMS in compliance with GMP and regulations.
• Oversee batch record review, deviation management, CAPA, audits.
• Lead QA team and mentor staff for professional growth.
• Manage regulatory inspections and customer audits with timely follow-ups.
• Review validation protocols for equipment, processes, and methods.
• Establish KPIs for quality operations and drive continuous improvement.
• Provide QA support for development, manufacturing, and supply chain.

Connaissances

GMP knowledge

Leadership

Quality assurance

Analytical thinking

Formation

Bachelor/Master in Pharmacy or related

Outils

QA software

Description du poste

About the Role

Our client, a distinguished player in the pharmaceutical industry, is actively seeking a highly motivated and experienced Senior Pharmaceutical Quality Assurance Manager to oversee quality operations in Klerksdorp, North West . This leadership position is integral to ensuring that all pharmaceutical products meet the highest standards of safety, efficacy, and quality, in strict adherence to regulatory guidelines. The ideal candidate will possess extensive knowledge of GMP, robust quality management systems, and proven leadership skills. This is a significant opportunity to make a substantial impact on product quality and regulatory compliance within a globally recognized organization committed to patient well-being. We are dedicated to fostering a culture of quality excellence.

Key Responsibilities

• Develop, implement, and maintain a comprehensive Quality Management System (QMS) in compliance with GMP and other relevant regulations.
• Oversee all QA activities, including batch record review and release, deviation management, change control, CAPA investigation, and internal/external audits.
• Ensure that manufacturing processes and facilities comply with all applicable regulatory standards and company policies.
• Lead and mentor the Quality Assurance team, providing guidance and fostering professional development.
• Manage regulatory inspections and customer audits, ensuring successful outcomes and timely follow-up actions.
• Review and approve validation protocols and reports for equipment, processes, and analytical methods.
• Establish and monitor key performance indicators (KPIs) for quality operations and implement continuous improvement initiatives.
• Provide QA support for product development, manufacturing, and supply chain activities.
• Conduct risk assessments and implement mitigation strategies to ensure product quality and patient safety.
• Ensure all personnel involved in GMP activities receive appropriate training.
• Stay current with evolving regulatory requirements and industry best practices.

Requirements

• A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• A minimum of 8 years of progressive experience in Pharmaceutical Quality Assurance, with at least 3 years in a management or supervisory role.
• In-depth knowledge and practical experience with GMP, ISO standards, and regulatory requirements (e.g., SAHPRA, FDA, EMA).
• Proven experience in managing a QMS, including all core elements (deviations, change control, CAPA, audits).
• Demonstrated leadership skills with the ability to manage and motivate a team.
• Experience in successfully hosting regulatory inspections and customer audits.
• Strong understanding of validation principles for processes, equipment, and analytical methods.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional written and verbal communication skills, with the ability to communicate complex issues effectively.
• Proficiency in quality management software and tools.

Benefits

Our client offers a highly competitive salary and an extensive benefits package, including top-tier medical aid, a substantial retirement annuity, and generous leave allowances. This role is based in Klerksdorp , a significant economic hub in the North West province. Join a company that prioritizes quality and offers excellent career advancement opportunities.