Johnson & Johnson Careers
Senior Manager, Source Quality
Requisition ID: 4579190513
Johnson & Johnson Medical Devices, (J&J MD), a division of the Johnson & Johnson Family of Companies, is recruiting for a Senior Manager, Source Quality located in the Raynham MA area.
J&J MD is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. J&J MD will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of several great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Reporting to the Director, Source Quality (External Manufacturing), the Senior Manager has primary responsibility to provide global Supplier Quality Assurance expertise, direction and guidance in the development, implementation and continuous improvement of Source Quality programs associated with the management of external manufacturers in the Mitek and Joint Franchises. You will provide Source Quality support in line with established J&J MD, industry and regulatory standards (e.g. QSR, ISO, EN, and Medical Device Directive (MDD) requirements). You will develop and monitor QA systems to ensure that all External Manufacturers meet their quality objectives with regards to supplier, process and product controls.
•establish, manage, maintain and continuously improve all Quality activities, including purchasing controls, associated with external manufacturers
•establish and execute the Quality strategy for the management of external manufacturers
•drive quality performance improvement of external manufacturers by developing quality capabilities and developing and implementing quality improvement plans
•recruit, develop and manage the Source Quality external manufacturing team to ensure a high performing team capable of delivering the groups objectives
•active participant in the selection, performance management, and disengagement processes for external manufacturers
•support Regulatory body audits at both MD sites and suppliers as required.
•actively drive all defined Supplier and External Manufacturing Quality Systems goals and objectives.
•partners with Source, Tech Op’s/External Make, and Enterprise Source Quality to develop the external manufacturing category strategy and ensure supply reliability for MD
•administer health authority, MD, and J&J policy requirements and standards to ensure the proper balance of business and compliance needs. Manage this balance to optimize continuous compliant growth within the external manufacturing supply base
•be the single point of contact within Source Quality for assigned sites/franchises and ensure that business needs are met.
•drives the resolution of quality issues affecting the compliance and/or supply continuity of goods sourced from external manufacturers
•develop and manage elements of the Source Quality budget. Establish, maintain, analyze, report and identify opportunities to improve the Source Quality operating budget.
•establish and report appropriate Source Quality business/quality & compliance measurements and analyze these measurements to identify the most significant issues and prioritize for action.
•ensure supplier related risks are escalated to management as required
•provide regulatory interpretation, consulting, training and assessment to ensure company Source Quality Management systems are aligned with current regulatory requirements, company standards and industry trends.
•provide Quality Engineering support to external manufacturers including inspection technique support, product non-conformances, verification/validation activities, CAPA, complaints, and change management as required
•ensure Source Quality input and participation in business reviews with suppliers as required
•promote continuous improvement and Process Excellence activities within the MD Source Quality Management group
•maintain supplier management documentation and records to ensure they are complete and current
•ensure that all Health, Safety, Housekeeping (5S), GMP, and Environmental requirements are fulfilled.
•A minimum of a Bachelor’s degree in engineering/scientific or associated relevant technical / engineering discipline is required. An Advanced degree in engineering/scientific or discipline is preferred.
•A minimum of 8 years progressive experience in a regulated industry like Medical Devices, Pharma and/or Consumer is required.
•A minimum of 4 years experience in a managerial capacity is required.
•Previous work experience with Suppliers is required.
•Demonstrated knowledge of business impact of compliance issues and risk management is required.
•Experience in leadership roles involving project management, problem solving and technical projects is required.
•This individual is required to possess high performing skills in negotiating and influencing decision makers, decision making skills, communication skills, judgement, tact and leadership skills.
•This position is located in the Raynham MA, area and will require up to 30% travel, including some international.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Depuy Orthopaedics. Inc. (6029)