Quality Control Manager

at  BI AH UK Ltd

THE POSITION

You will manage all Quality Control activities linked to batch release on the Pirbright site. You will interface directly with the Site Leadership team in terms both developing and supporting the site strategic plan. You will be responsible for developing priorities and deliverables for Quality Control that are in line with site strategy.
This role is based at our manufacturing site in Pirbright, requiring a minimum of 3 days per week on site.

REQUIREMENTS

• A life sciences degree or equivalent
• Experience of working in a regulated, laboratory environment
• A strong knowledge of biologics processes through education or past experience
• Experience of managing and leading teams.
• Strong communicator both within the team and across other functions and senior levels of leadership
• Strong influencer
• A team player and a leader who is able to work to deadlines and ability to manage and coach others
• Good knowledge of Quality assurance systems, GMP and ability to work to strict standard operating procedures is desirable

• Develop and drive the Quality culture across the QC team. Maintain the expected level of GMP and ensure compliance to the site QMS process is maintained both to an expected quality standard and in line with batch release priorities.
• Ensure the Quality Control department adheres to all aspects of site compliance - Biosafety, HSE and GMP. Work closely with local leads for these functions to ensure standards remain in line with Corporate and Regulatory guidelines.
• Develop and encourage a Continuous Improvement culture within QC. Lead by example to develop best practices to reduce waste, reduce spend and drive batch release on time and first time through. Drive excellence through the SPQDC process.
• Manage the QC cost center and budget to ensure spend remains in line with budget commitments and site International Production Costs metric
• Develop and maintain KPI metrics for QC to track critical deliverables and drive process improvements.
• Develop a quality network across other BI sites to bring other best practices to the site as well as share Pirbright best practices across the network
• Manage all aspects of site Quality Control testing both inclusive of batch release, raw materials release, utilities and facilities conformance. Ensure batches are controlled and released in line with customer commitments.
• Line manage Quality Control leads for the both the QC Restricted and Controlled labs. Develop and coach direct reports to manage and lead their teams in line with AAI values and the MAG process.