Senior Manager Quality and Regulatory
5 days ago
**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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