Head of Quality - Medtech
Full Time Permanent
Northern Cross
The Head of Quality & RP is responsible for the development, implementation, and maintenance of the Quality Management System (QMS) within Medtech Business This role ensures compliance with GxP guidelines, GDP/GMP regulations, and Medical Device standards, while driving continuous improvement and operational excellence. Acting as the Responsible Person (RP) for the Medtech WDA, the incumbent will lead quality initiatives, manage regulatory inspections, and foster a culture of quality across the business.
Key Responsibilities:
- Serve as Responsible Person for WDA, ensuring full compliance with GDP and Medical Device regulations.
- Develop, implement, and maintain the QMS in line with regulatory requirements Uniphar Global polices and best practices.
- Lead regulatory and client inspections, ensuring readiness and successful outcomes.
- Collaborate with internal and external stakeholders to maintain efficient, compliant processes.
- Drive continuous improvement initiatives across quality systems and operations.
- Manage outsourced activities and ensure provider compliance.
- Analyse audit results, identify gaps, and implement corrective actions.
- Prepare and maintain quality reports, KPIs, and documentation for senior management.
- Provide leadership and development for the Quality team, fostering a high-performance culture.
- Stay current with evolving regulations and ensure timely implementation of changes.
- Act as a strategic partner / trusted advisor to the business, aligning quality initiatives with organisational goals. Drive innovative quality solutions that support business growth and transformation.
- Partner with group quality and divisional quality teams when required to enhance quality practices and embed into business processes.
Qualifications & Experience:
- Bachelor’s degree in science, Engineering, or related discipline (preferred).
- 5+ years’ experience in a regulated industry (GDP/GMP/Medical Devices).
- Proven experience in regulatory inspections and compliance management.
- Strong leadership skills with ability to manage and develop a team.
- Excellent organisational, analytical, and problem-solving abilities.
- Familiarity with validation methodologies and risk management principles.
- Proficiency in MS Office and quality-related software tools.
- Project management experience is an advantage.