Academic Quality Assurance Director

1 month ago


Dunstable, Central Bedfordshire, United Kingdom Real Staffing Full time
Site Head of Quality Assurance

Our client, a leading pharmaceutical company, is seeking a highly skilled Site Head of Quality Assurance to lead the Quality Assurance activities at one of their company sites.

Key Responsibilities:
  • Establish and maintain GMDP standards for all site activities, ensuring compliance with regulatory requirements.
  • Align with the broader organization to ensure uniform high standards, sharing best practices for the benefit of the organization.
  • Develop and implement a clear site-level governance process, feeding into the organization committee.
  • Deliver clear and concise scorecards on a weekly basis, in conjunction with the Site Director, including status and progress.
  • Escalate issues of significance in a timely manner at site level and beyond.
  • Lead and demonstrate a continuous improvement mindset, planning to have a deputy capable of supporting robust operations.
  • Implement independent audit systems for internal audits of relevant departments.
  • Manage risk governance processes, proactively managing site risk.
Duties:
  • Lead the site Compliance Council process.
  • Lead regulatory inspections linked to GMDP, H&S.
  • Deputise for the Site Director on matters associated with Ethics and Compliance.
  • Build a relationship with the regulators that impact the site.
  • Support the building of a high-capability and high-delivery team linked to compliance with the Company HR team.
  • Lead site recall activities as required.
Requirements:
  • Ideal candidate will have a degree-level education or a track record in a similar position.
  • Life Sciences - Pharmaceutical manufacture and Distribution experience is essential.
  • Oral Solid Dose and Generics expertise is desirable.
  • Quality Assurance Management of site-level activities is a must.

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.



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