QA Manager - Qualified Person (IMP OR Commercial)
Salary details available on discussion + Relocation support
My client is a leading CDMO company based on the South Coast who due to company growth and on-going expansion are currently seeking an experienced QA Manager and QP to join their business on a permanent working basis. The company have over 150 employees and having recently announced a large investment in their UK operations are building a state of the art 70,000 square foot manufacturing and Pilot Plant. This position will be responsible for the operational scale up and management of the new eQMS/PQS and building and developing an ever increasing operational Quality Assurance team underneath the QD.
If you are looking for the opportunity to develop yourself, departments and grow an expanding packaging and manufacturing facility then this could be just the role for you. With excellent internal progression opportunities and the opportunity to step into a role with commercial and operational oversight, now really is the time to get in contact to explore further.
The role will be responsible for directly line managing the Quality Assurance department (currently 2 heads, with plans for you to grow this) and will take responsibility for all Quality activities related to the development and progression of said department. As Quality Manager for their leading Manufacturing site which includes manufacturing, packaging, testing, R&D, storage and distribution functions.
This broad role, will see you responsible for overall operational management of the quality function to GMP standards; people management of 2 direct reports; actively perform duties as a QP for the site; support the GMP audit program as well as inspection readiness activities and hold responsibility for working cross functionally with both manufacturing sites & wider stakeholder teams (e.g. R&D, Engineering, Clinical Development at local and regional level and external parties (e.g. Regulatory Authorities and Clients)
Other key responsibilities will include:
- Demonstrated experience as a releasing QP (ideally OSD)
- Clinical and Product Development experience, ideally as a QP on an MIA licence
- Eligibility to act as a QP un the UK
- Experience of eQMS/PQS operation and optimisation
- Previous experience as a Quality Manager, with line management responsibility
- Ability to enhance the quality culture
- Experienced in hosting, and conducting audits both internally and externally
Inspection readiness experience including a right first time mentality
Successful applicants must be able to demonstrate excellent management/leadership experience as well as 5+ years of hands on releasing QP experience (Ideally within OSD), within a manufacturing environment.
You must also be able to show:
- The ability to establish and maintain effective working relationships with internal and external stakeholders.
- Extensive knowledge of Quality Assurance, Quality Systems, GMP, Regulatory Compliance and manufacture and packaging of pharmaceutical products.
- Demonstrated knowledge, understanding and application of GMP guidelines and regulations.
- Fluent English communications skills (written & spoken).
- Ability to interpret complex data and present key findings.
To apply for this role, please call Bob Beevers at Life Science People on +44 7890 551 627 or send an updated version of your CV via email
If this role is not for you, we do operate a bonus referral scheme should we go on to successfully place someone that you recommend to us so please feel free to share these details within your network.