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Site Head of Quality Assurance

2 months ago

Dunstable, Central Bedfordshire, United Kingdom Real Staffing Full time
About the Role

We are seeking a highly skilled and experienced 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 (e.g. lean, six sigma etc.)
  • 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 and 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
  • Manage DMRC communication as required
Requirements
  • Ideally Degree level education or track record in a similar position
  • Life Sciences - Pharmaceutical manufacture and Distribution
  • Oral Solid Dose and Generics
  • Quality Assurance Management of site level activities