Sr. Source Reg Compliance Specialist

Johnson & Johnson Johnson & Johnson · Pharma · Leeds, West Yorkshire, United Kingdom

This role is responsible for executing and supporting regulatory compliance activities related to sourcing, suppliers, and externally provided processes within a regulated healthcare industry. It ensures suppliers comply with regulatory requirements, quality system standards, and internal policies, impacting product quality and audit readiness.

What you'd actually do

  1. Execute source regulatory compliance activities including supplier audit execution, investigation approval, and objective evidence review, to ensure adherence to regulatory and quality system requirements
  2. Support compliance oversight for suppliers, contract manufacturers, and externally provided services.
  3. Partner with Supply Chain, Procurement, Quality, and Regulatory Affairs teams to support compliant supplier qualification and lifecycle management.
  4. Interpret regulatory requirements and support translation 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
  • 4-6 years of experience in Regulatory Compliance, Quality, Supply Chain, or related roles within a regulated industry
  • Working knowledge of regulatory and quality requirements impacting sourcing and supplier operations
  • Experience leading supplier audits, inspections, or compliance assessments
  • Ability to manage complex compliance topics and documentation with strong attention to detail
  • Strong analytical, organizational, and problem‑solving skills
  • Effective written and verbal communication skills

Nice to have

  • Advanced degree in a scientific or regulatory field
  • Experience in medical devices, healthcare, or other highly regulated industries
  • Familiarity with global regulatory and supplier compliance expectations
  • 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)
  • Additional European language
  • Agile Internal Audit
  • Analytical Reasoning
  • Audit and Compliance Trends
  • Communication
  • Compliance Management
  • Compliance Policies
  • Compliance Risk
  • Controls Compliance
  • Critical Thinking
  • Problem Solving
  • Quality Auditing
  • Quality Control (QC)
  • Quality Standards
  • Regulatory Environment
  • Standard Operating Procedure (SOP)

What the JD emphasized

  • regulatory requirements
  • quality system standards
  • supplier compliance