"Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.
The Site Senior Quality Source Manager serves as the on-site Johnson & Johnson Medical Devices (JJMD) representative for the Strategic Collaborator (SC). You will ensure that appropriate communication channels are established and maintained between JJMD and the SC. You will also oversee site activities with potential impact to JJMD product quality, quality management system, and brand integrity.
As the Site Senior Quality Source Manager, you will be 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, you partner with the respective SC site management team for their sphere of influence to develop and support initiatives and responses to internal quality issues.
You will also partner with SC assessing their Quality System through input to Management Review and Joint Quality Reviews at the SC and JJMD levels. Further, you will have the necessary independence, authority and responsibility to communicate quality problems according to the J&J escalation standard and Quality Agreement. This role is a key member of the JJMD Supply Chain team as well a key partner to the SC Supply Chain network.
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:
Establish and maintain training development of lot release activities
Establish and maintain training development and execution of JJMD quality personnel performing lot release certification and monitoring activities
Track and analyze lot release certification and monitoring data in order to measure program effectiveness and to identify trends. Report data analysis, including any negative trend, through Management Review and Joint Quality Review.
Review and approve Nonconformances and CAPAs resulting from the lot release certification and monitoring processes, including root cause investigation, product impact assessment, bounding, and applicable corrective action plans.
Oversee Site JJMD Quality Engineering activities as defined by the Quality Agreement.
Supervise site JJMD quality organization, including salary and wage associates:
Evaluate and recommend staffing requirements to ensure maximum utilization of personnel to fulfill department objectives
Set departmental yearly goals
Recommend salary increases and promotions for direct reports
Recruitment and onboarding of new staff
Conduct performance appraisal, compensation, people development plans, and training curricula
Approve departmental purchases and personnel company expenses
Perform team communications
Promote, terminate, and transfer direct staff, as required
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/Bachelor Degree or Equivalent
Requires five (5+) years of related experience in areas such as Quality Operations, Compliance, Quality Systems, Quality Management, Design Quality, etc.
Three (3+) years of supervisory experience
Quality Management experience within J&J is preferred
Stakeholder management
Leadership and management skills
Excellent communication and interpersonal relation skills
Regulatory compliance knowledge and skills
Advanced Quality Systems knowledge
Interpretation and application of QSR, ISO Standards and other relevant global regulations
Advanced computer and use of software applications(s)
