R&d Qa Manager - Gvp

Mundipharma

Cambridge, United Kingdom
Not specified; not specified; flexible benefits py...
Hybrid
Good pharmacovigilance practice (gvp) compliance
Third-party vendor quality oversight
Pharmacovigilance system master file ownership
The role serves as a guardian of patient safety and regulatory compliance within the R&D QA team

Job Summary

  • The role serves as a guardian of patient safety and regulatory compliance within the R&D QA team.
  • Candidates will lead third-party vendor oversight and manage the integrity of the Pharmacovigilance System Master File.
  • The position offers flexible benefits and opportunities for learning and development in a collaborative environment.

Matching Summary

The role serves as a guardian of patient safety and regulatory compliance within the R&D QA team.

Salary

Not specified; Not specified; Flexible benefits package

Skills & Requirements

Must-have

  • Good Pharmacovigilance Practice (GVP) compliance
  • Third-party vendor quality oversight
  • Pharmacovigilance System Master File ownership
  • R&D audit planning and execution
  • Regulatory inspection support experience

Nice-to-have

  • Good Clinical Practice (GCP) knowledge
  • MHRA, EMA, or FDA interaction experience
  • Root cause analysis and CAPA management
  • Risk-based quality decision making
  • Collaborative inclusive work environment

Key Requirements

  • Scientific degree in Pharmacy, Chemistry, Biology, or Engineering
  • Extensive practical QA experience in Pharmaceutical industry
  • Certification in Quality Systems Management or auditing preferred
  • Proven track record supporting PV teams with regulators

Work Rights

Not specified

Tailored Resume

Cover Letter