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Cranberry Township, Pennsylvania; Somerville, New Jersey; Warsaw, Indiana; Cincinnati, Ohio; West Chester, Pennsylvania; Irvine, California; Raynham, Massachusetts; Bridgewater, New Jersey; Monument, Colorado; Palm Beach Gardens, Florida
Requisition ID: 1995180129
DePuy Synthes Companies of Johnson & Johnson is seeking a Compliance Manager to be located in one of the listed DePuy Synthes locations.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies 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 two 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.
The Compliance Manager will be a key leader in the analysis and development of Global Orthopedic field action metrics and operational reports (example – monthly executive decks, analysis for QSMR, analysis for QPR, competitor analysis, raw data summaries, One MD, ad hoc reporting). You will work with groups within Quality and Compliance and collaborate with key partners within One MD.
You will be the main point of contact for field action metrics and will maintain an in-depth business relationship with the key partners and will facilitate, govern, and lead report creation.
Additionally, the Compliance Manager will support the development and execution of a harmonized One MD program for external standard and regulations management that includes monitoring, assessing impact, tracking, governance and metrics.
- Interface and collaborate with key stakeholders and business partners in the analysis, design and development of ad-hoc reports, metrics and dashboards for field actions
- Develop and distribute a monthly analysis of field actions, including executive decks and competitor analysis according to stakeholder timelines.
- Support Regulatory Inspection readiness initiatives and activities across GxP disciplines, as required
- Research emerging regulatory trends and changes in regulations and external standards to communicate to the business to ensure ongoing compliance to these requirements.
- Monitors through metrics the performance of the assigned assessment of new or changes to regulations and external standards
- Conduct internal audits.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer
- Bachelor degree in science, engineering, quality or other technical field
- Minimum of 8 years quality and/or compliance experience in the medical device and/or pharmaceutical industry
- A minimum of 3 years’ experience directly performing audits in the medical device industry and/or pharmaceutical industry
- Advanced expertise with Microsoft Excel
- Proven ability to synthesize data, interpret data, and process observations into actionable recommendations.
- Ability to manage multiple tasks, prioritize with minimal direction and call out to management when appropriate.
- Analytical skills and experience leading risk-based oversight programs
- Ability to manage complexity and ambiguity
- Project management experience
- Technical skills in Spotfire, Tableau or similar software
- Direct contact/interaction experience with the FDA, ISO registrars and other health authorities.
- Familiar with the Medical Device Single Audit Program
- Auditor Certification, such as ASQ CQA
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.Johnson & Johnson Family of Companies areequal opportunity employers, and all qualifiedapplicants will receive consideration for employmentwithout regard to race, color, religion,sex, sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law.
United States-Pennsylvania-Cranberry Township
North America-United States-Indiana-Warsaw, North America-United States-Colorado-Monument, North America-United States-Pennsylvania-West Chester, North America-United States-California-Irvine, North America-United States-Massachusetts-Raynham, North America-United States-New Jersey-Somerville, North America-United States-New Jersey-Bridgewater, North America-United States-Florida-Palm Beach Gardens, North America-United States-Ohio-Cincinnati
Depuy Orthopaedics. Inc. (6029)