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Head of Quality Assurance

2 months ago

Dunstable Bedfordshire, United Kingdom Real Full time

Our client is an established pharmaceutical company engaged in the development, manufacture, marketing and distribution of generic medicines in the UK and Europe.

They offer a wide range of high-quality medicines to the healthcare sector, that optimises cost efficiencies whilst ensuring reliable supply. They are now looking to hire a Site Head of Quality to lead the Quality Assurance activities at one of the company sites.

The site Head of Quality will lead the designated site in terms of GMDP quality and compliance, including in the areas of: QA, QC, GMP, GDP, QP activities and RP activities in line with the business goals and plan.

Responsibilities:

  • Establish clear and compliant GMDP standards for all site activities
  • Align with the broader organisation, to ensure organisation has uniform high standards
  • Share best practices, for the benefit of the organisation
  • Establish a clear site-level governance process, feeding 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 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

Qualifications

  • 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
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