Site Head of Quality Assurance

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 efficiency whilst ensuring reliable supply. They are now looking to hire a Site Head of Quality Assurance for their site in the North East.

The Site Head of Quality Assurance will lead the designated site in terms of compliance, including in the areas of: QA, QC, GMP, GDP, QP activities and RP activities.

Responsibilities:

• Establish clear and compliant GMP/GDP 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 in relation to QA
• 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
• The Head of Quality Assurance will 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 operations, including when senior staff are absent or unavailable
• Lead on Governance, Quality and H&S and Environmental matters
• The Head of Quality Assurance will 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 etc.
• Deputise for the Site Director on matters associated with Ethics and Compliance
• Build a relationship with the regulators that impact the site e.g. MHRA etc.
• 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/Skills:

• Ideally Degree level education or track record in a similar position
• Solid Dose and Generic Pharmaceuticals
• Quality Assurance Management
• Ideally QP status although this isn't a deal breaker

To find out more about Real, please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office |8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales