Manager, Source Reg Compliance (na)

Johnson & Johnson Johnson & Johnson · Pharma · Palm Beach Gardens, FL +4

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.

What you'd actually do

  1. Lead and manage source regulatory compliance activities across North America, ensuring adherence to regulatory and quality system requirements.
  2. Provide regulatory and compliance oversight for suppliers, contract manufacturers, and sourced components.
  3. Partner with Supply Chain, Procurement, and Quality teams to ensure compliant supplier qualification, monitoring, and lifecycle management.
  4. Interpret regulatory requirements and translate them into sourcing and supplier compliance expectations.
  5. Support internal audits, external audits, and health authority inspections related to sourcing and supplier compliance.

Skills

Required

  • Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or a related discipline
  • 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 have

  • Advanced degree in a scientific, regulatory, or business field
  • 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

What the JD emphasized

  • regulatory requirements
  • quality system standards
  • internal policies
  • product quality
  • audit readiness
  • compliant supply continuity
  • supplier qualification
  • monitoring
  • lifecycle management
  • compliance risks
  • trends
  • performance metrics
  • corrective and preventive actions
  • global and regional compliance policies
  • procedures
  • controls
  • continuous improvement
  • supplier compliance
  • sourcing governance