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Vice President, Quality Assurance - Biologics

Vice President, Quality Assurance - Biologics

  • Location

    Wales

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    TBC_1584963412

  • Published:

    6 months ago

  • Expiry date:

    2020-03-26

  • Consultant:

    #

Job title: Vice President, Quality Assurance - Biologics

A speciality pharmaceutical business in Wales are seeking a Vice President, Quality to develop global strategy for the quality function. This role will assess and report the state of quality, communicate emerging and new regulations, recommend best practice and identify areas for process improvement.

Responsibilities:

  • Lead QA, QC, CMC, PV and QMS compliance
  • Develop and implement global quality and validation systems and ensure "fit for purpose" compliance
  • Lead the inspection readiness strategy and ensure each location has an inspection readiness leader
  • Advise key stakeholders on pertinent quality standards and direct quality and QA validation groups in implementing, conducting or coordinating GxP audits/inspections
  • Manage the GCP Quality Assurance function and support clinical development teams to ensure compliance with GCP regulations
  • Provide regular reports on all Quality and Technical related issues to the Pharma Leadership Team.

Requirements:

  • A Qualified Person (QP)
  • Significant senior level experience in QA, QC, CMC Regulatory Affairs, and GMP auditing and compliance leadership gained within the biologics industry.
  • Extensive experience in both Facility and Product Filing and inspection management with the FDA, MHRA and other Regulatory Agencies.
  • Detailed knowledge of Quality systems as well as global GMP requirements and experienced in delivering GMP training and a strong appreciation of global GCP requirements.
  • Educated to degree level in Life Sciences or equivalent
  • Willing to travel within UK, EU or internationally for up to 25% of time.

Salary and benefits:

A competitive annual salary, biannual bonus, pension and healthcare are on offer.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk