Quality Manager – South Africa
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 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.
Required Experience:
Manager
Employment Type : Full-Time
Experience: years
Vacancy: 1