J&J Family of Companies Compliance Manager in West Chester, Pennsylvania
DePuy Synthes, a member of the Johnson & Johnson Family of Companies is recruiting for a Compliance Manager to be based in West Chester, PA or Somerville, NJ.
The Compliance Manager serves as the Johnson & Johnson Medical Devices (JJMD) compliance representative for the External Strategic Collaborator (ESC). He/she ensures that appropriate compliance communication channels are established and maintained between JJMD and ESC. The Compliance Manager Oversees site compliance activities and ensures effective business wide compliance program that meets requirements with potential impact to JJMD products. The Compliance Manager ensures that the Quality System (QS) is in compliance with the established QS requirements and Quality Agreement and determines the effectiveness of the Quality System through compliance programs. The compliance manager has the necessary independence, authority and responsibility to communicate compliance problems according to the J&J escalation standard and Quality Agreement. This position will partner with JJMD Compliance leaders and ESC Quality Operations & Compliance to ensure effective Internal Audit process, site inspection readiness and overall compliance support and guidance.
Principal Duties and Responsibilities:
Inspection response & subsequent follow up
Commitment follow up
Readiness planning / transition for significant changes in Regulations (EuMDR, MDSAP)
Compliance metrics collection, trending and reporting
ERC Follow up
Field Action Assessments
Joint supplier Review
Partner and Support Supplier Quality Program
Notified Body change management / Notification
Management of External Standards and Regulations site support
Purchasing control assessments
A Bachelor’s degree and a minimum of 6 years’ experience in a regulated industry is required
Demonstrated Quality and Compliance experience in domestic and international medical device, pharmaceutical and combination product quality systems is preferred
Direct experience with FDA inspections in a leadership role, is required
Certified Quality Auditor (CQA) is preferred
Experience with progressive quality systems, quality control, quality assurance, including hands on advanced quality systems compliance is required
Experience with Change Management as it relates to audit readiness is a plus
Experience working and managing in both a direct and highly matrixed global environment is preferred
Interpretation and application of QSR, ISO Standards and other relevant global regulations is preferred
The ability to continuously assess the effectiveness of functional processes and lead progressive improvement initiatives is required
Strategic mindset as it pertains to compliance programs with strong leadership ability, interpersonal, communication, and influencing skills is required
Strong collaboration skills, the ability to communicate written and verbally in a virtual global environment and to work effectively with cross-functional teams is required
Ability to analyze, balance, and prioritize risk is required
This position will be based in West Chester, PA or Somerville, NJ and may require up to 25% domestic and international travel, based on business needs.
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.
United States-Pennsylvania-West Chester-
United States-New Jersey-Somerville
Depuy Orthopaedics. Inc. (6029)