Site Head of Quality Assurance
6 days ago
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
- 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
- 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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