Johnson & Johnson Careers

Site Senior Quality Source Manager - West Chester, PA

West Chester, Pennsylvania
Quality Assurance


Job Description

Requisition ID: 1025181228

DePuy Synthes, a member of the Johnson & Johnson Family of Companies, is recruiting for a Site Senior Quality Source Manager located in West Chester, PA.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

Last year J&J announced a long-term strategic collaboration with Jabil. This long-term collaboration includes the transfer of the Synthes manufacturing sites located at Monument, West Chester, and Horseheads to Jabil. This unique opportunity builds on our leadership in medical devices, complemented by Jabil’s manufacturing and supply chain solutions, to produce a range of current and future products within the DePuy Synthes business. It would drive a different way of innovating at the intersection of products and technology, and provide us with a unique competitive advantage for our portfolio of the future. The newly created Senior Quality Source Manager role, enables this key operating model for J&J overseeing the relationship between Jabil and J&J and ensuring we maintain the high levels of quality, safety, reliability, and service our customers and patients depend on.

The Site Senior Quality Source Manager serves as the on-site Johnson & Johnson Medical Devices (JJMD) representative for the Strategic Collaborator (SC). He/she ensures that appropriate communication channels are established and maintained between JJMD and the SC. 

The Site Sr. Quality Source Manager oversees site activities with potential impact to JJMD product quality, quality management system, and brand integrity. The Site Sr. Quality Source Manager is accountable for ensuring that the SC has a clear understanding and ability to execute to the JJMD Quality System and the Quality Agreement requirements. Critically, the Site Sr. Quality Source Manager partners with the respective SC site management team for their sphere of influence to develop and support initiatives and responses to internal quality issues. He/she partners with SC assessing their Quality System through input to Management Review and Joint Quality Reviews at the SC and JJMD levels. Further, the Site Sr. Quality Source Manager has the necessary independence, authority and responsibility to communicate quality problems according to the J&J escalation standard and Quality Agreement. The Site Sr. Quality Source Manager is a key member of the JJMD Supply Chain team as well a key partner to the SC Supply Chain network.

Key Responsibilities:
• Oversee execution of the Quality Agreements and Transitional Service Agreements (TSA) between SC and JJMD.
• Oversee Lot Release Certification and Monitoring Program for JJMD products.
• Oversee Site JJMD Quality Engineering activities as defined by the Quality Agreement.
• Supervise site JJMD quality organization (~4-7 direct reports) including salary and wage associates.
• Collaborate with SC on escalation decisions as per Quality Agreement.
• External audit support for JJMD products and/or quality systems.
• Reviews site monthly dashboard and establishes (with SC) improvement plans to address below target metrics and negative trends.
• Support Joint Quality Review process.
• Support SC/JJMD Product Focus Teams.
• Provides input into the site Quality Plan & yearly Quality Objectives.
• Provide SC with guidance and connection to JJMD organization towards the resolution of issues and/or improvements related to JJMD Products.

Qualifications
• University/Bachelors’ degree or equivalent required
• Minimum five (5+) years of related experience in areas such as Quality Operations, Compliance, Quality Systems, Supplier Quality, Quality Management, Design Quality, etc.
• Three (3+) years of supervisory experience highly preferred
• Advanced Quality Systems knowledge required
• Interpretation and application of QSR, ISO Standards and other relevant global regulations required
• Audit experience required.
• Quality Management experience within J&J is preferred
• Regulatory compliance knowledge and skills
• Stakeholder management
• Leadership and management skills
• Excellent communication and interpersonal relation skills
• Advanced computer and use of software applications(s)
• Technical Writing Skill
• Statistical and analytical problem solving
• Advanced Project Management skills
• Coaching skills
• ~10-15% domestic travel is required

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.

IND10

Primary Location
United States-Pennsylvania-West Chester-
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality Assurance
Requisition ID
1025181228