VP, Quality

Biotechnology and Pharmaceutical VP, Quality Job Description:This executive role in Quality Assurance requires the candidate to lead the oversight and integrity of all Quality for Boston Scientific devices for assigned commercial divisions. Partner with Division business Presidents to establish product quality and compliance strategies. This position requires the ability to take innovative ideas from proof of concept through commercialization. Ensuring Quality compliance at all assigned manufacturing sites this includes new product validations as a requirement. Utilizes extensive internal contacts across BSC and external contacts with industry specialists to drive initiatives and develop the Quality organization. The role also acts as a liaison between the company and various governmental agencies and notified bodies around the world to foster compliance within BSC.Can be designated Quality Systems Management Representative in place of the Multi-Site VP of Quality Assurance when required.Duties and Responsibilities:- Provides global vision and leadership for Quality organization and determines therapeutic area Quality objectives and links those objectives to division and corporate objectives- Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established company, international (ISO), and governmental regulatory standards and agency guidelines, and to ensure lasting customer satisfaction. - Act as the Quality Systems Management Representative for assigned division and site. Participate in Management Review Process as well as: - Maintain compliance to Corporate Quality Management System - Manage and maintain effectiveness of Quality Management System - Represents the business or site to outside regulatory bodies - Ensures submittal to the company a monthly report summarizing trend analysis on their defined and applicable quality system clauses and corresponding quality objectives via the Management Review System - Facilitates the awareness of regulatory and customer requirements throughout the organization- Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance, and then assist the organization in driving implementation.- Determines and establishes assigned Quality organizational structure and supervisory relationships with direction and support from division President and Multi Site VP of Quality function.- Collaborates with multiple cross-functional colleagues to ensure achievement of standards and regulations during product development and commercialization activities- Represents Quality function on assigned management board and influences executive decision making regarding prioritization of all projects to obtain critical resources and funding for projects.- Develops and manages (directly and indirectly) relationship and interface with the regulatory agencies (domestically and internationally).- Coaches, develops and mentors Quality employees. Allocates/re-allocates internal and external resources, as needed Minimum Education & Experience:Candidate possesses a B.S. Degree with a minimum of 15 years management experience in quality and regulatory for medical devices and pharmaceuticals. The majority of experience should be in medical devices. An advanced engineering degree or MBA is highly desirable. Demonstrable record of achievement in managing Quality Systems at multiple sites and success in commercializing products on time, on budget is critical. Candidate must have the ability to devise strategy and execute effectively. Good grasp of FDA protocol and process.Job Experience:Minimum Education & Experience:Candidate possesses a B.S. Degree with a minimum of 15 years management experience in quality and regulatory for medical devices and pharmaceuticals. The majority of experience should be in medical devices. An advanced engineering degree or MBA is highly desirable. Demonstrable record of achievement in managing Quality Systems at multiple sites and success in commercializing products on time, on budget is critical. Candidate must have the ability to devise strategy and execute effectively. Good grasp of FDA protocol and processMinimum Education Required: BachelorExpected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.