Manager, Source Reg Compliance (NA)

Johnson & Johnson Innovative Medicine • West Chester, PA

4d • $102,000 - $177,100 • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or a related discipline (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.
• English required.

Nice To Haves

• Advanced degree in a scientific, regulatory, or business field (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.
• Quality or Regulatory certifications preferred but not required.

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.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager