Senior Manager Quality and Regulatory

5 days ago


Eastern England, United Kingdom BioTalent Full time
Job Description

**Senior Manager Quality and Regulatory**

BioTalent is seeking a highly experienced and skilled Senior Manager Quality and Regulatory to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and regulatory compliance across our operations.

Key Responsibilities:

  • Act as EU Responsible Person for MHRA licenses designated as WDA and Home Office Licenses.
  • Act as key contact for MHRA and oversee QMS maintenance.
  • Plan, direct, and monitor regulatory affairs activities and maintain regulatory compliance according to relevant guidelines and regulations.
  • Oversee and maintain ISO certifications and CE marking compliance.
  • Liaise with external vendors, contractors, or suppliers.
  • Plan and conduct inspections and audits of the site and external vendors and suppliers.
  • Manage a team of experienced Quality Professionals.

Essential Skills and Qualifications:

  • Bachelor's degree or higher in a Science-related discipline.
  • Extensive QA/RA experience within pharmaceuticals or medical devices.
  • Experience acting as EU Responsible Person is essential.
  • QMS experience to the relevant ISO standards: 9001 or.
  • Demonstrated leadership skills and experience managing a team.

Desirable Skills:

  • Accredited Auditor Certification is desirable.
  • Good understanding of GDP.
  • Knowledge of risk management and applicable standards (ISO).


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