Head of Regulatory & Compliance

Hyper Recruitment Solutions are currently looking for a Head of Regulatory & Compliance to join a leading company based in the Wokingham,Berkshire area. As the Head of Regulatory & Compliance you will be responsible for

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Head of Regulatory & Compliance will be varied however the key duties and responsibilities are as following:

1. Lead and manage a team of 15 employees from manager to specialist level.
2. Drive continuous improvement in the Quality Management System (QMS)
3. Act as the Audit Lead for all Regulatory and Client audits.
4. Work closely with the department management team to release protocols and reports to clients.
5. Ensure all personnel are trained in GMP and GLP.
6. Deliver full site compliance with local and global operating standards.
7. Roll-out of CSV and 21CFR11 compliance across the site.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Head of Regulatory & Compliance we are looking to identify the following on your profile and past history:

1. Relevant degree in Science
2. Proven industry experience in Pharmaceutical or Biotechnology
3. A working knowledge and practical experience with GLP and GMP.
4. Prior leadership experience ideally within a CRO/CMO environment

Key Words: Compliance, Regulatory, Quality Assurance, Quality Control, Pharmaceutical, biotechnology, biologics, CMO, CRO, GMP, GLP