Location: Wallonia, Belgium
Sectors: Quality Assurance (QA)
Job Type: Contract
- Overseeing the implementation of a Quality Plan, Quality Management System, Quality Management Policy, Quality Goals, and applicable regulations and internal standards
- Assure site and business is properly prepared for external and internal compliance inspections/audit
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Having the authority to issue concessions, stop production, make decisions about people and budget accountability
- Assure business goals are established and met for compliance, training, CAPA, complaints and production process control across sites/regions.
- Maintains product quality by enforcing quality assurance policies & procedures and industry requirements; collaborating with other members of management to develop new product and engineering designs.
- Lead team to design, implement, and improve Supplier Quality processes ensuring Supplier Quality compliance to the QMS, regulatory requirements and overall process improvement.
- Develop & implement effective regulatory strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements
- Lead and support improvement activities, including such areas as regulatory procedure development and documentation, standards compliance, and metrics development and implementation.
- Liaise with external regulatory bodies to guide input into regulatory strategies
- Educate, train, & advise company professionals to ensure compliance with RA requirements.
- As appropriate, recruit, mentor, coach & train direct and indirect reports on activities within areas of responsibility
- Proven application of analytical skills in a regulatory environment
- Demonstrated knowledge of regulatory issues, and experience interfacing with local & international regulatory bodies, such as FDA, European competent authorities & notified bodies, Health Canada, etc.
- Demonstrated project management skills: ability to prioritize, plan, evaluate & execute deliverables for established tactical goals
- Ability to influence and make recommendations at multiple levels of the company
- Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer's requirements.
- Bachelor's Degree & minimum of 5 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies
- Demonstrated experience operating in a highly regulated environment