VP Quality EMEA (M/F)
Job Description SummaryAbout BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers.
About the role
As VP Quality EMEA, you will work within a global, matrix environment and will need to have a strong technical foundation and aptitude coupled with the ability to be a “collaborative facilitator” and leader championing the overall mission of BD EMEA Quality. You must represent varied interests across the matrix and must establish and operate processes to ensure an ongoing and self-sustaining improvement in overall compliance both for the short and long term.
You will provide strategic guidance necessary to gain and maintain global quality and compliance standards of excellence for the EMEA Region for all new and marketed products and will collaborate with the other key functions to determine and promulgate the BD “line to take” with respect to new and emerging trends and regulations.
As VP Quality EMEA, you will report to the Vice President of International Quality. You are responsible for leading the Go-To-Market QualityOperations andbeing a member of the EMEA leadership team. The role has key accountabilities for Quality Management and certification in Country Commercial entities, supporting tenders and all customer-facing processes with a GMP, GDP or compliance element including quality from the Distribution Centers, through the delivery of product and the process for capturing and processing any complaints subsequently received. You will lead Complaint management through the operation of the RCCs and for Post-Market Quality through the operation of theCoEsfor Field Action and Adverse Event Reporting. The geographical and business scope for this portfolio is enterprise-wide with accountability across EMEA.
Inaddition,you willsupport, develop, implementand operatea robust and integrated regional quality system at DistributionCentersand Complaint ManagementCenterswithin Europe and EMA, and willact as a Quality business partner to the EMEA leadership team.Youwill interact with WW BU Quality leaders and other business functional leaders/stakeholders (e.g., RA, Legal, Medical, R&D, platform leaders, etc.).
Other key responsibilities include:
Integrating the work within the Regions with BU, Central and Functional Leaders to assure that the EMEA Regional Quality organization supports compliance activities and priorities, and current Quality Management strategic goals and objectives to provide effective, efficient quality systems that create customer value addressing elements critical to business success, continuity and competitive advantage.
Participating in identifying and leading quality initiatives in the Regions that include any BU, supply chain and Shared Service Centre process improvements. You will be the voice of customers in the Regions for all products sold in the Regions; and will show a commitment to excellence focusing on meeting or exceeding both internal and external customer expectations. Active engagement with Regional Competent Authorities and Industry opinion leadership is a feature of the role.Development and improvement of the Regulatory Compliance capabilities, and enhancing and supporting continued improvement of performance, in EMEA.
Strongly employ best practices and tools to accelerate quality excellence, learnings, results and initiating lessons learned into the regional organization. He/she will maximize the benefits for the overall system to drive BU, Integrated Supply Chain and SSC performance and customer satisfaction. He/she will also lead a quality culture that enables innovation and drives operational effectiveness by leveraging BD’s continuous improvement methodology.
Enhance talent management by building leadership competencies and associate capabilities. He/she will have responsibility for building capacity and capability within the team, recruiting and developing members and directing, supporting and mentoring direct reports.
You benefit from a minimum of 15 years of experience in quality management with at least 5-7 years of senior compliance management experience in an FDA/Competent Authority regulated environment including managing of multi-cultural teams executing locally in different countries(strong preference for FDA Class II and Class III medical device experience).You have demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP, GLP, GCPand are also experienced in all regulatory compliance aspects of the business: pre-market, commercial, post market, and regulatory.
A strategic thinker, youtake any role and make it betterthrough yourrelentless dissatisfaction with statusquo. The customer is at the heart of your actions and your focus is on driving customer value by acting as a change agent in the organization.
Additional requirements include:
BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree and MBA preferred.
Demonstrated expertise in working with Regulatory Agencies to address issues.
Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment.
Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
Strong intellectual curiosity and pursuit of knowledge. Cultivates new ideas. Comfortable with ambiguity and uncertainty.
Displays Global Perspective Establishes and promotes effective quality and regulatory processes across multiple countries and/or regions and coordinates appropriately with the broader global business.
If this describes you and your aspirations, then please click on the APPLY button.
Primary Work LocationCHE Eysins - Business Park Terre-Bonne
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