Head of Quality Control

Summary

• To manage all functions within Quality Control Department: Commercial, API & Cleaning, Raw Materials, Projects, Technical Support, Stability, Materials and to provide QC data in accordance with cGMP principles, including Data Integrity, to agreed cost and cycle.
• Working with the QC functional heads to ensure compliance with all safety and quality compliance regulations and in accordance with cGMP.
• Responsible for delivering the QC Optimisation Plan and continually reviewing existing and developing new initiatives to drive continuous
• Effective control of QC budget, specifically focusing on headcount/overtime costs, consumable costs and departmental capital expenditure.

Key Responsibilities

• Provision of a function that DI complaint QC data to support GMP decision making across clients full portfolio of products & services, to agreed standards of cGMP, cost and cycle
• Ensuring the QC department is aligned with business requirements and projections over a 12 month
• Manage the medium to long term resource strategy for the department, aligning to site goals and business
• Embedding a process of continual review of performance, efficiency and utilisation in line with business strategy. Lead the communication of performance via departmental scorecards
• Effective control of QC budget, specifically focusing on headcount/overtime costs, consumable costs and departmental capital expenditure.
• Develop departmental development plans, to ensure a flexible workforce across all QC Working with the functional leaders to define individual plans and support the execution and delivery of the plans. Ensure the development and motivation of the team by providing effective training and the creation of development opportunities
• Identify and sponsor Improvement initiatives within the department. Deliver upon the QC Optimisation Plan and continually review existing and developing new initiatives to drive continuous
• Participate as a member of the site Quality Management Team, including attendance at the weekly Site Quality Review Team meetings and the Quality Management Review
• Lead audits within the QC facility, provide tour of the facility, with an overview of Act as the QC SME within audits, representing QC systems including OOS/OOT management and data integrity.
• Maintain QC OTIF in line with customer requirements – support ‘getting tablets to patients’
• Manage the department in efficiently and effectively and in compliance with the agreed and identified metrics
• Act as the key contact to clients and customers in relation to QC activities and ensure full technical support either directly or indirectly through delegation

Required experience

• Detailed knowledge and experience of managing a Quality Control function within a fast moving, compliance driven environment
• Extensive people-manager experience
• Communication, negotiation, GMP expertise, policy deployment and awareness of customer service & financial objectives

Work Conditions/Requirements 

• Full time role
• Site based