Academic Quality Assurance Manager

2 days ago

Dunstable, Central Bedfordshire, United Kingdom Real Staffing Full time
Job Title: Academic Quality Assurance Manager

We are seeking an experienced Academic Quality Assurance Manager to lead our Quality Assurance activities at one of our company sites.

Key Responsibilities:
  • Establish clear and compliant GMDP standards for all site activities
  • Align with the broader organization to ensure uniform high standards
  • Share best practices for the benefit of the organization
  • Establish a clear site-level governance process, feeding the organization 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
  • Plan to have a deputy capable of supporting robust operations, including when senior staff are absent or unavailable
  • Lead on Governance, Quality, H&S, and Environmental matters
  • Implement independent audit systems for internal audits of relevant departments
  • Manage risk governance processes, 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 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

Real Staffing 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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