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Quality and Regulatory Affairs Senior Manager

2 months ago

Liverpool, Liverpool, United Kingdom BioTalent Full time

Senior Manager Quality and Regulatory

BioTalent is excited to offer an opportunity to work with a prominent provider of healthcare solutions that operates in over 30 countries globally.

Key Responsibilities

  • Serve as the EU Responsible Person concerning MHRA licenses classified as WDA and Home Office Licenses, acting as the primary liaison for the MHRA.
  • Ensure the ongoing maintenance of the Quality Management System (QMS).
  • Strategically oversee regulatory affairs initiatives and uphold compliance with applicable guidelines and regulations.
  • Manage and sustain ISO certifications along with CE marking adherence.
  • Collaborate with external vendors, contractors, and suppliers.
  • Organize and execute inspections and audits for both the facility and external partners.
  • Lead a team of skilled Quality Professionals.

Essential Qualifications and Skills

  • A Bachelor’s degree or higher in a relevant scientific discipline.
  • Significant experience in Quality Assurance/Regulatory Affairs within the pharmaceutical or medical device sectors.
  • Proven experience as an EU Responsible Person is mandatory.
  • Familiarity with QMS in accordance with relevant ISO standards: 9001 or 13485.
  • Demonstrated leadership capabilities with experience in team management.

Preferred Skills

  • Certification as an Accredited Auditor is advantageous.
  • Solid understanding of Good Distribution Practice (GDP).
  • Knowledge of risk management principles and relevant standards (ISO 14791).

We are currently in the process of shortlisting candidates for this role. For further details, please reach out for a confidential discussion.