Head of Quality and Regulatory
Biotechnology Executive Pharmaceuticals
Location Europe, Scotland, South/Central Belt Scotland, USA
Salary Very Competitive
Are you a dedicated individual with management experience within the Biopharmaceutical industry? If so..
CY Partners, are currently supporting a leading Biopharmaceutical company in their search for a Head of Quality and Regulatory. This is a fantastic opportunity to join an exciting fast-growing company, were you will be responsible for the strategic direction of the Cell and Testing Services our client provides. It will be your responsibility to ensure regulatory compliance of all testing locations, and requirements of the FDA and EU are met. The role is to be based at several key locations across, Scotland’s central Belt, Germany and USA.
We’re looking for a highly motivated individual, who wants to strive to make an impact, deliver targets, and help build a high performing team.
You will be responsible for:
- Maintaining company standards and regulatory licenses (e.g. MA (IMP))
- Ensuring GMP, GLP and GCP compliance is achieved throughout the testing and manufacturing facilities
- Develop and implement a shared Quality framework across all locations
- Implement suitable QMS systems to meet compliance, client and business needs
- Recruit, develop and lead a focused and dedicated Quality team with regulatory knowledge
- Providing guidance and expert knowledge on items relating to cGMP compliance, Internal and External auditing, validation and processes
- Delivering training and assessment on Quality & Regulatory issues
- Maintaining the Cell and Testing Services Budget
What you need:
- Experience in a licensed drug, or biologic facility regulated by FDA, EMEA in a senior quality role
- A degree in a relevant scientific discipline is preferred
- Proven practical application of the Regulations essential, particularly:
- Directive 2001/83/EC, Directive(s) 2003/94/EC and 2011/62/EU
- Directive 2001/20/EC
- 2003/94/EC; Eudralex Volume 4
- QP training desirable
- UK Good Laboratory Practice Regulations, 1999 [Statutory Instrument 3106, as amended)
- Good Clinical Practice for testing laboratories
- Be the Subject matter Expert in at least 1 areas of validation (assay, equipment, CSV)
In return, you will be rewarded with a competitive salary, company pension scheme, private medical and much more.
Think the role is just what you’re after? Don’t delay and apply today. Alternatively, if you’d like to know more call Owain at CY Partners.