Quality Assurance Manager
2 weeks ago
This is a key leadership role requiring a candidate with demonstrable experience in Quality, strategic thinking, exceptional communication, and analytical skills to support our clients’ vision, mission, and values.
Responsibilities:
- Ensure compliance with all applicable standards and legislative requirements in line with EU regulations.
- Collaborate with the global QA team to implement an Electronic Quality Management System and enhance Integrated Management Systems.
- Oversee regulatory, customer, and vendor audits.
- Develop and maintain initial and ongoing training programmes across all divisions of the organisation.
- Manage the Change Control process to ensure the controlled implementation of all GxP-related changes in accordance with relevant SOPs.
- Review and approve Corrective and Preventive Actions (CAPAs), ensuring proper tracking, follow-up, and evaluation of their effectiveness.
- Lead and oversee QA responsibilities related to Packaging and Labelling activities, ensuring successful implementation.
- Conduct validation and qualification of GMP equipment, systems, and facilities.
- Maintain regular communication across all departments (QA, Logistics, Project Management, Sourcing, Purchasing, Operations, HR, Regional Teams, etc.) to ensure seamless information flow.
Skills, Experience, and Qualifications:
- At least 3 years of QA experience within clinical trials, pharmaceuticals, or medical devices.
- Qualified RP (Responsible Person), with prior experience as the lead RP.
- Strong understanding of European regulations and guidelines.
- A diploma or degree from a recognised college or university, or equivalent professional experience.
- Supervisory experience is desirable.
- Familiarity with Electronic Quality Management Systems.
- Willingness and flexibility to travel as required.
- GMP or GDP experience within pharmaceuticals, medical devices, or clinical trial supplies (CTS).
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