Site Head of Quality

Description:

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 ComplianceDuties:

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 requiredQualifications

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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