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Site Head of Quality Assurance

2 months ago

Cambridgeshire and Peterborough, United Kingdom Real Full time
About the Role

We are seeking a highly experienced and skilled Site Head of Quality Assurance to lead our Quality Assurance activities at one of our company sites.

Key Responsibilities
  • Establish and maintain clear and compliant Good Manufacturing Practice (GMP) standards for all site activities
  • Align with the broader organisation to ensure uniform high standards
  • Share best practices for the benefit of the organisation
  • Establish a clear site-level governance process, feeding into the organisation committee
  • Deliver clear and concise scorecards, on a weekly basis, in conjunction with the Site Director, including status and progress
  • Deliver a weekly report, in conjunction with the Site Director, communicating areas of challenge, delivery and risk
  • Escalate issues of significance, in a timely manner at site level and beyond
  • Lead and demonstrate a continuous improvement mindset, incorporating lean and six sigma principles
  • Plan to have a deputy, capable of supporting robust operations, including when senior staff are absent or unavailable
  • Lead on Governance, Quality and Health and Safety (H&S) and Environmental matters
  • Implement independent audit systems for internal audits of relevant departments
  • Risk governance processes, looking at understanding and proactively managing site risk
  • Establish/Improve on metrics, to demonstrate and understand changes in the performance of the site, in terms of Compliance
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 compliance, with the Company HR team
  • Lead site recall activities, as required
  • Manage DMRC communication, 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
  • Oral Solid Dose and Generics expertise
  • Quality Assurance Management of site-level activities