Quality Director

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 Head of Quality Assurance for one of their sites.

The 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
• Oral Solid Dose and Generic Pharmaceuticals a plus
• Quality Assurance Management
• Ideally QP status although this isn't a deal breaker for exceptional candidates

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