Quality Director

Barron Williams have been retained to deliver this key search and selection instruction for our client, a global leader in generic medicines and biopharmaceutical products. With an innovative portfolio, they have been developing and producing medicines for over a century and now have an impressive portfolio of over 3,000 products, one of the largest of any pharmaceutical company in the world, helping nearly 200 million people in 60 countries every day. Research and development of innovative medicines is key to their continued success, together with an uncompromising commitment to quality and compliance through each stage of the development and commercialisation process. With a global manufacturing network of over 50 sites in 33 countries, the Quality and Compliance function plays a crucial role in meeting their commitments to patients and to the regulatory agencies that approve their medicines. They continually monitor manufacturing processes and supply chains to ensure product performance and each product is tested to confirm compliance to quality specifications and compliance standards. As a result, they have an enviable record of Current Good Manufacturing Practice (cGMP) compliance, as assessed by the US Food and Drug Administration (FDA) and other global regulatory organisations.

Our client is now seeking a first-class Director of Quality for their manufacturing site in NW England as a key part of their plans to further develop particular global product markets, inc. the US & Europe. Leading a Quality team of over 100, you will take responsibility for all aspects of Quality and Compliance in supporting both Operations and NPD as part of the site senior leadership team. Your responsibilities will include; materials and finished products, product quality, testing and all compliance/regulatory matters, including inspections and audits. You will be an experienced pharmaceutical Quality professional with a demonstrable track record of effective leadership in similar manufacturing settings. You will have broad experience across QA, QC as well as Regulatory matters, inc. inspections (e.g. MHRA & FDA). Practically, your pharmaceutical manufacturing experience will include the effective use of OPEX techniques as well as ERP/MRP systems, and ideally including the production of sterile products. This is a great opportunity to join a company that cares about its people and how they work together, providing fulfilling roles in producing essential medicines every day.

Job Title: Quality Director

Location: NW England

Reports to: Global Director of Quality / Site GM

Functional Reports: Quality Team (c120 colleagues)

Package: Attractive six-figure remuneration inc. perf-related bonus & benefits package

Key Deliverables:

• Leadership - drives performance to consistently deliver against the site Quality & Operations Plans.
• People development - delivers critical Quality function capabilities by creating a high calibre talent pool
• As part of the site SLT, work closely with the site GM to deliver the Sterile Operations Strategy
• Lead your team in delivering against Quality metrics, across QA, QC & Regulatory functions
• Develop partnership-led relationships with the range of teams on site,supporting a single team culture
• Manage risk, pro-actively plan and co-ordinate the achievement of site regulatory and compliance KPI’s
• Taking a holistic view of the business, create and execute an integrated Quality strategy for the long term
• Simplify, review current processes and practices to reduce complexity and improve functional efficiency
• Build strong and effective relationships with colleagues, external partners and regulatory bodies

Candidate Profile:

• A suitably qualified pharmaceutical Quality professional with experience in relevant manufacturing sites
• Broad experience across QA, QC as well as Regulatory matters, inc. inspections (e.g. MHRA & FDA).
• Excellent leadership credentials, can lead and develop large, high performing specialist teams
• Experience of the effective use of OPEX techniques as well as ERP/MRP systems in pharma
• Steriles experience (inc. aseptic) and/or QP status would be advantageous but not essential
• Chemistry, Pharmacy (or Microbiology ideal) or relevant degree
• An engaging, determined and instantly credible Quality professional, ready for their next challenge

Apply in confidence via the link provided or contact Paul Barron contact details provided for a confidential exploratory discussion.