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Manager, Source Reg Compliance (NA)

$102k - $177.1k
Full-time

Johnson & Johnson Innovative Medicine

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality & Compliance Audit Job Category: Professional All Job Posting Locations: Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America Job Description: DePuy Synthes is recruiting for a Manager, Source Regulatory Compliance (NA), located in Palm Beach Gardens FL or Raynham MA or West Chester PA. Job Overview The Manager, Source Regulatory Compliance (NA) is responsible for leading regulatory compliance activities related to sourcing and supplier operations across North America. This role ensures that external manufacturing partners, suppliers, and sourcing processes comply with applicable regulatory requirements, quality system standards, and internal policies. The position plays a critical role in safeguarding product quality, supporting audit readiness, and enabling compliant supply continuity by partnering closely with Quality, Supply Chain, Regulatory Affairs, and Procurement teams. Key Responsibilities Lead and manage source regulatory compliance activities across North America, ensuring adherence to regulatory and quality system requirements. Provide regulatory and compliance oversight for suppliers, contract manufacturers, and sourced components. Partner with Supply Chain, Procurement, and Quality teams to ensure compliant supplier qualification, monitoring, and lifecycle management. Interpret regulatory requirements and translate them into sourcing and supplier compliance expectations. Support internal audits, external audits, and health authority inspections related to sourcing and supplier compliance. Monitor compliance risks, trends, and performance metrics; drive corrective and preventive actions. Ensure consistent application of global and regional compliance policies, procedures, and controls. Drive continuous improvement initiatives to strengthen supplier compliance and sourcing governance. Qualifications Education: Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or a related discipline (required). Advanced degree in a scientific, regulatory, or business field (preferred). Experience and Skills Required: Typically 6-8 years of progressive experience in Regulatory Compliance, Quality, Supply Chain, or related roles within a regulated industry. Strong working knowledge of regulatory and quality requirements impacting sourcing and supplier operations. Experience supporting supplier audits, inspections, and compliance assessments. Ability to manage complex compliance topics across cross‑functional stakeholder groups. Preferred: Experience in medical devices, healthcare, or other highly regulated industries. Familiarity with North America regulatory and sourcing compliance requirements. Experience working in a global or matrixed organization. Exposure to regulatory inspections involving supplier or contract manufacturing oversight. Quality or Regulatory certifications (e.g., RAC, ASQ). Strong analytical, risk‑management, and problem‑solving skills. Effective communication and collaboration skills. Other: Language: English required. Travel: Moderate domestic travel across North America. Certifications: Quality or Regulatory certifications preferred but not required. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource. #LI-Hybrid #DePuySynthesCareers Required Skills: Preferred Skills: Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Compliance Frameworks, Compliance Management, Compliance Policies, Compliance Risk, Critical Thinking, Process Improvements, Quality Auditing, Quality Control (QC), Quality Standards, Regulatory Compliance, Risk Management, Technical Credibility, Third-Party Auditing The anticipated base pay range for this position is : $102,000.00 - $177,100.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: • Vacation –120 hours per calendar year • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year • Holiday pay, including Floating Holidays –13 days per calendar year • Work, Personal and Family Time - up to 40 hours per calendar year • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year • Caregiver Leave – 80 hours in a 52-week rolling period10 days • Volunteer Leave – 32 hours per calendar year • Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Do Not Sell or Share My Personal Information Limit the Use of My Personal Information

Vacancy posted 2 days ago
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