Quality Manager – South Africa

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description About the Role Thermo Fisher Scientific is seeking a Quality Manager to lead quality and compliance activities for Fisher Clinical Services South Africa. The site supports clinical trial supply operations, including clinical packaging, labeling, distribution, returns, and destruction. This role is responsible for maintaining a strong quality system, ensuring compliance with applicable regulatory standards, and leading a small Quality team. It is a key site leadership role for someone with strong pharmaceutical quality experience, people leadership capability, and the ability to build a culture of quality, compliance, safety, and continuous improvement. Key Responsibilities Lead, coach, and develop a team of Quality professionals. Ensure site compliance with corporate and divisional quality policies, procedures, cGMP, and GDP requirements. Act as Management Representative for the site quality system and safety management system. Manage deviations, complaints, quality investigations, and CAPA through to effective resolution. Maintain a robust local self-inspection program. Support client, supplier, internal, and regulatory audits. Provide quality guidance to clients, suppliers, and internal teams. Oversee facility and equipment qualification and validation activities, including review and approval of validation reports. Identify and deliver relevant QA and GMP training across the site. Use quality data, audit findings, and compliance monitoring to drive continuous improvement. Partner with site leadership and cross-functional teams to strengthen quality culture, operational performance, and customer confidence. Must-Have Requirements Prior quality experience in a pharmaceutical environment. Prior people leadership or team management experience. Strong knowledge of quality management systems and regulated industry requirements, including cGMP and GDP. Experience managing deviations, CAPA, complaints, investigations, audits, and quality system improvements. Strong communication, stakeholder management, and problem-solving skills. Preferred Qualifications Degree in Chemistry, Biology, Engineering, Pharmacy, or a related scientific or technical field. Lead Auditor certification in ISO 13485 or ISO 9001. Experience with ISO 9001, ISO 13485, FDA QSR, or equivalent regulated quality standards. Experience with quality management software such as TrackWise or document control systems. Experience with Lean, Six Sigma, or other continuous improvement methodologies. Project management experience. Ability to travel up to 20% as required. Why Join Thermo Fisher Scientific At Thermo Fisher Scientific, our work supports our Mission to enable our customers to make the world healthier, cleaner and safer. In this role, you will help ensure clinical trial supply activities are managed with the quality, compliance, and reliability required to support critical research and advance healthcare. You will join a team that values quality leadership, professional growth, collaboration, and meaningful impact.