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Head of Quality Assurance Opportunity, Belgium
We are delighted to be supporting a global Laboratory Research specialist in the medical sector who are looking to identify and appoint a Global Head of Quality Assurance.
This is a key strategic position within the organisation and the successful candidate will take a key lead in developing quality assurance across the business. Given the senior nature of the role there is an expectation of 10 years practical working experience in Quality assurance in Research or supporting medical Industries ie Biotechnology, Med Tech/Devices/Pharma (Product dependent), IVD.
To lead and manage the strategic and operational performance of the Quality department, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to regulatory compliance and achieving commercial success as well as inspection readiness. To ensure the efficient and effective day to day running of the department.
To develop a QA culture within the organisation.
- Develop and implement the Quality department's strategy, to ensure it meets the business requirements and customer deliverables, as well as ensure the departmental performance against goals.
- Manage customer relationship on QA matters
- Implement and monitor all Quality Assurance systems and tools required to comply with quality guidelines such as Good Clinical Practices, Good Clinical Laboratory Practices, ISO & CAP guidelines, and other pertinent regulations and standards. This includes control over global transparency of global procedures, local procedures and specific working instructions.
- Lead internal and external inspections as required.
- Lead review and assessment of non-conformities and non-compliant findings - originating from internal and external audits, complaints and other investigations - and ensure appropriate corrective and preventive actions are agreed and effectively followed up. Guarantee good documentation practice.
- Implement and maintain a Quality Risk Management system to ensure that risks are adequately identified, assessed and controlled in accordance with current requirements
- Direct Quality Control and training programmes.
- Maintain and improve departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, and cost.
- Ensure that all activities are performed in accordance with company SOPs and Health and Safety policies.
- Direct and approve the audit strategy and programme. This includes both internal audits as well as external audits of lab partners and subcontractors. Ensure the audit programme is communicated to Operations and involved Support Functions.
- Manage all validation activities, including validation strategy
- Maintain an awareness of new and proposed legislation that impacts the business and communicate any changes to the relevant stakeholders within the organisation.
- Ensure that the Quality department meets or improves on budget, cost, and efficiency targets (KPIs) in line with business objectives.
- QA resource planning: maintain and ensure sufficient staff in the different QA departments at all times, and ensure appropriate training and cross training is provided to the employees.
- Directly manage Regional QA Leads. Provide direction and guidance to the QA team: manage, motivate, coach and mentor direct reports, develop the Quality team structure.
- Set up and establish Quality Agreements and appropriate governance with third-parties.
- Act as the main point of contact on all Quality matters, internally and externally.
Package and Benefits
- 120k-150k Euro Basic Salary
- 20k Euro bonus
- Car or car allowance
- Pension, medical & Wider package
Key Skills, Qualifications and Client Requirements
- Master's Degree in science, with 10+ years of experience in Quality Assurance or clinical trial business in a global environment
- Extensive knowledge of national and international quality systems (ISO, GLP, GCP, …) and clinical trial processes
- Strong and accurate communicator
- Strong interpersonal and influencing skills
- Analytical skills, flexible in dealing with problems
- Excellent time management skills
- Ability to work in a fast pace environment
- Fluent in Dutch, English, both oral and written; knowledge of French is an asset
What Happens Next?
If you are interested in finding out more about this role please click the 'Apply' button. On submission of the job application form, an email alert is sent to the specialist consultant handling this role to register your interest.
All dialogue with us is in the strictest of confidence, without any obligation and we will NOT send your details to the relevant business without your consent.
Alternatively, to find out more about this role or any other roles that maybe relevant, you can email us at [email protected] or call our Medical Devices team on 01423 813456