Quality & Compliance Director
This is an exciting time to join us, Custom Pharma Services (CPS) has begun a £20 million program of investment in state-of-the-art facilities for product development and commercial supply of OSD products. The new facilities are designed to formulate and supply high potency products within a new 70,000 sq. ft. facility in Brighton, Sussex.
Due to the retirement of the current Quality Director, a dynamic and highly motivated individual is required to join the existing Senior Management Team. The successful candidate will help to drive future growth in contract services heading up Quality & Compliance and Health & Safety. The position reports to the CEO and will play a key role in collectively setting and delivering overall Company Strategy for future growth.
Quality & Compliance Director Responsibilities:
In summary this will include:
– Managing, maintaining and improving quality, safety and compliance cost-effectively across Custom Pharma Services
– Facilitating the expansion of the QMS, to ensure the success of Custom’s 5-year Business Plan to create a Clinical to Commercial CDMO business model, serving global pharma clients. Ensuring that the QMS is “stage appropriate” for the range of services provided from pre-clinical through clinical to commercial supply.
– Work to fulfil the high-level objective of turning Custom into a world class CDMO, delivering Contract Clinical Services, Formulation Development and Commercial supply of OSD products in line with the company strap line “Clinical to Commercial”.
The successful candidate will have experience of a similar leadership role and looking for their next career move. You will ideally have previous experience of:
– Building, leading and managing QA/QC functions during business growth and expansion
– Product Formulation Development and Commercial Supply of OSD Medicines
– Meeting Regulatory Compliance standards for the EU, US and other international markets
Quality & Compliance Director Requirements:
Qualifications, knowledge, skills & experience
– Proven experience in a senior leadership role, ideally at Board level in the pharmaceutical industry
– QP status (Permanent Provisions under 2001/83/EU as amended) is desirable but not essential
– A working knowledge and experience of UK/EU and US regulatory standards and procedures
– Familiar with the compliance requirements of global quality cGMP
– Experience in implementing quality assurance systems in a GMP/GCP/GLP/GDP/IMP/Specials licensed enterprise
– Experience of strategic and financial planning and control, including managing revenue and capital budgets
– Experience of Lean and Six Sigma, process & operational process improvements
– Clear understanding of the requirements of Health & safety and as a minimum IOSH Directing Safely training or similar
– Experience of or ability to adapt to working in an SME
About Custom Pharma Services (CPS):
CPS is a full-service “Clinical to Commercial” CDMO and holds various licences to operate a range of services which includes MIA, MIA(IMP), MS, WDA(H), API and ManA. CPS is an independent OSD specialist pharma contract services provider. CPS produces a range of formulations including modified release and potent products such as hormones at low dose. New development and commercial manufacturing facilities for high potency contained processing are under construction at a site adjacent to our existing Brighton, Moulsecoomb packaging and QC facilities.
Location: Hove, BN3 3LW
Hours: Full Time, Permanent
Benefits: 25 days holiday; pension; life assurance; health plan: bike to work scheme and annual profit related company and individual bonus payment based on successful performance.
Strictly no agencies please.
Applicants must have the right to work in the UK.
Successful candidates will be required to complete a basic disclosure check.
Relocation Assistance will be taken into consideration for candidates who are not based within commuting distance of Brighton & Hove
How to apply
Please submit your application including a covering letter explaining how your skills and experience meets the requirements of the role
You may have experience of the following: Pharmaceutical Director, Quality Director, Compliance Manager, Head of Strategy, Quality Assurance Manager, Financial Planning, Lean Six Sigma, Health and Safety, Director, Quality Manager, etc.