Quality Manager

Quality Manager

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Location : On site - Based in Skipton, BD23
Salary : £40,000 - £60,000 per annum, DOE + Excellent Benefits!
Hours : Monday - Friday, 40 hours per week (typically 08:00 - 16:30)
Benefits: 25 days annual leave plus statutory holidays, Option to purchase one additional week's holiday (salary sacrifice), Auto-enrolment pension, Healthcare Cash Plan and Life insurance (2 salary, death in service)
Lunara is a newly formed Contract Development and Manufacturing Organisation (CDMO), currently in the build phase ahead of operational start-up.
The company is progressing towards Home Office controlled drugs authorisation, a Manufacturer's Specials (MS) licence, and a Wholesale Distribution Authorisation (WDA(H)).
We are now recruiting for a Quality Manager to establish, implement and maintain Lunara's Quality Management System (QMS) to ensure full compliance with medicines legislation, controlled drug regulations, GMP, and GDP.
The role includes acting as:
Quality Controller named on the Manufacturer's Specials (MS) Licence
Responsible Person (RP) named on the WDA(H)
You will ensure that all products are manufactured, tested, released, stored, and distributed in full regulatory compliance, with patient safety and product quality as the primary focus.
As our Quality Manager you will:
Build, implement, and maintain the Quality Management System in line with regulatory requirements
Act as Quality Controller for the MS licence and Responsible Person for the WDA(H)
Serve as the primary quality contact for the MHRA, Home Office, and other regulatory bodies
Ensure all SOPs, quality processes, and documentation are current, controlled, and embedded
Oversee GMP/GDP compliance across manufacturing, testing, storage, and distribution activities
Ensure staff training is completed and maintained in line with GMP/GDP and company procedures
Promote a robust quality culture across the organisation
In order to be successful in this role you must have / be:
Degree in Pharmacy, Pharmaceutical Science, Life Sciences, or another relevant scientific discipline (preferred)
Eligibility to act, or previous experience, as a Responsible Person under WDA(H) requirements (preferred)
Minimum of 3-5 years' experience in a Quality role within a regulated pharmaceutical environment
Experience operating under GMP and GDP, ideally within MS and/or WDA(H) licences
Experience establishing or developing quality systems and processes
Strong working knowledge of UK regulatory frameworks and inspection expectations
Strong attention to detail and commitment to quality
High ethical standards and professional integrity
Confident decision-maker with the ability to assess risk and apply sound judgement
Clear communicator with the ability to influence stakeholders at all levels
Proactive, structured, and solutions-focused approach
Any offer of employment will be subject to a satisfactory standard DBS check and compliance with applicable regulatory and legislative requirements.
Interested in Learning More
If you would like to explore this opportunity further, please apply with your CV.
Shortlisted applicants will receive a full recruitment pack and benefits with further details about Lunara and the role. xwzovoh
No agencies please.