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Job title: European Quality Director – Microbiology Europe
Location: Basingstoke, UK
- Oversee a strong global quality team by hiring and developing strong quality managers, establishing and actively managing performance expectations, and providing training and career development opportunities to team members. Set clear roles and responsibilities across the network with pro-active management controls.
- Lead, coach, and motivate Quality teams at seven sites across Europe, Middle East and Africa (EMEA). Ensure that sites are compliant to mandatory regulatory requirements including Quality Management Systems standards i.e. ISO 9001, ISO 13485, ISO 17025, FDA (21CFR280) and the European In-Vitro Diagnostics Directive.
- Help sites prepare for, and actively support, external audits (customer & regulatory) ensuring corrective/preventative actions are put in place to address identified non-conformances.
- As part of the senior quality leadership team, help to develop and communicate a Divisional Quality vision. Define and manage strategic objectives that align with the business strategy, as well as the annual key Operational Imperatives, as a member of the Divisional Extended Leadership Team
- As the designated Management Representative, interact with all agencies and institutions that regulate or assess the Microbiology Division quality system and regularly report the effectiveness of the system to Microbiology Division senior management
- Set network wide quality priorities and key objectives to reduce the cost of poor quality and improve the compliance to regulations and the site Quality Management System. Ensure KPI’s are maintained, and appropriate root cause countermeasures are put in place where targets are being missed.
- Oversee global Quality Control team performance to meet standard turnaround times, QC test first pass yield (test/retest error), OOS actions, and labour efficiency.
- Ensure global training is effective and that the plants operate within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective.
- Ensure effective management of the divisional and site Quality Management System including assuring effective management reviews, complaint handling, post market reviews, CAPA and incident management, change control, calibration maintenance, process validation, internal auditing, R&D transfers, and manufacturing area support.
- Provide global quality system leadership to ensure internal policies, customer expectations and regulatory requirements are met.
- Oversee the continuous improvement of Quality Management Systems at sites around the world, ensuring the sharing of best practices to improve overall divisional compliance.
- Closely partner with the Global Regulatory organization to ensure compliance to applicable regulations. Actively participate as a member of the Portfolio Steering Group, to ensure new product development aligns with design-for-quality expectations
- Effectively use continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Quality service levels, reduce costs, and align with strategic objectives.
- Closely partner with customers to adapt the management system and manufacturing methods to meet cGMP and applicable regulatory requirements.
- Build strong working relationships across organizations and geographies. Use deep domain expertise and insight into cGMP, qualification and validation activities, to partner effectively with engineering and operations teams to drive a compliant Right-First-Time culture.
- Ability to demonstrate flexibility and manage multiple complex projects simultaneously.
- Position requires a Bachelor’s of Science Degree in a biological science discipline, or QA discipline
- Minimum of 10 years’ experience in pharmaceutical, medical device or in-vitro diagnostics industry, with at least 5 years in direct support of Quality Assurance.
- Prior experience leading teams across multiple regions/areas.
- Experience hosting and managing successful external regulatory authority inspections.
- Well-versed in the development and execution of quality management systems, with domain expertise in national and international standards, e.g. ISO, ICH, EU GMP, 21 CFR Parts
- Project planning and working knowledge of Excel, Word, and quality management software
- Excellent interpersonal skills with ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment
- Leadership skills: Proven ability to lead diverse technical teams; to influence others; to lead significant change; and negotiate for compliant win/win outcomes
- Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decisiveness and ambition
- Strong communication skills both written and verbal
- Willingness to travel 20-30%
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