Ath, Walloon Region, Belgium
Skills and Competencies: • Multi-locations, multi-cultural and multi-disciplinary team leadership • Strong knowledge in Quality System Management, pharma labeling, Suppliers Quality and CMO, Supply Chain Quality and Good Distribution Practices • Focus on continuous improvement through LEAN, DMAIC and EMS • Strong adaptability and high autonomy • Results oriented, customer minded, team builder, change and innovation driver • Operational Excellence: quality, costs, deadline, talent management, safety, environment
Reporting to the Vice President Quality, Medical Products and Therapies. As Sr Director of Quality MPT for EMEA and APAC, I am accountable for implementing the mid-long-term strategy, leading and leading the quality resources in the plants I am responsible for to support the new product development projects, commercialized products. In my role, I am also responsible to maintain and improve the compliance profile of the MPT sites I am in charge of. The main areas of responsibility are: • Responsible for multi plant management for entities manufacturing solution/drug/medicinal products for the MPT business in EMEA and APAC (i.e.: Sabinanigo plant, Spain / Lessines, Belgium / Toongabbie, Australia / Thetford, UK / Qiaguang BQ, China). My role also covers Medical Device plant in Tel Aviv, Israel and San Vittore in Switzerland. • Responsible to cascade the Corporate quality Goals • Responsible to interact and support the Quality leaders in order to accomplish the business strategy • Responsible for the integration of new businesses/acquisitions into the Baxter Quality System • Responsible for sponsoring, planning and conducting special QA/compliance projects My role requires good communication ability, high level of Management skill and strong leadership to support various programs at Baxter.
Quality Assurance Director and Quality Management Responsible for the Baxter Lessines manufacturing site. I am responsible for all quality assurance departments (e.g.: QC, validation, Micro labo, process quality, Quality systems, Release) composed of 123 employees. Part of the site leadership team.
• Full centralization of labeling design activities/artwork creation in Malta - Relocation of Labeling design activities in Malta: expert role and core team member - Hiring of new team in Malta (4 Managers and 38 Designers) - Definition of Baxter labeling process ideal state - Transition of work from current labeling centers to Malta • Responsible of Supplier Quality EMEA People: responsible for the EMEA Supplier Quality hub; 5 managers – 20 employees based across Europe (France, Germany, CZ, Belgium, Italy and Sweden). Process: responsible for selection and approval of suppliers. - Support projects linked to suppliers (e.g., CMO, API certification, new suppliers, audits) - Manufacturing sites support (e.g., conduct supplier audits, complaints, NCR/CAPA’s, supplier changes) - Close interface and networking with Global and Regional Stakeholders (Manufacturing, Regulatory Affairs, PSM, Supply Chain, R&D and Business) • Product transfer (Medical Devices) People: supervise a team composed of 1 Supervisor, 1 consultant and 2 contractors. Project: transfer to Baxter activities currently executed by another company in terms of release and product management of third party Medical Devices (Class III and Class IIa). - In charge of product transfer and release (e.g., coordinate supplier quality activities, establish CMO management in plant, transfer and validation of release method, product specifications) - Responsible for QA activities related to Supply Chain transfer - FDA readiness program for Lessines site, obtaining EC certificate following Notified Body audit Mar 2017