Sr. Source Reg Compliance Specialist in Leeds

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.

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.

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.

The Sr. Source Regulatory Compliance Specialist is responsible for executing and supporting regulatory compliance activities related to sourcing, suppliers, and externally provided processes. This role ensures that suppliers, contract manufacturers, and sourced materials comply with applicable regulatory requirements, quality system standards, and internal policies. The position has a direct impact on product quality, audit readiness, and supply continuity by partnering closely with Quality, Regulatory Affairs, Supply Chain, and Procurement teams across the region.

Key Responsibilities

• Execute source regulatory compliance activities including supplier audit execution, investigation approval, and objective evidence review, to ensure adherence to regulatory and quality system requirements.
• Support compliance oversight for suppliers, contract manufacturers, and externally provided services.
• Partner with Supply Chain, Procurement, Quality, and Regulatory Affairs teams to support compliant supplier qualification and lifecycle management.
• Interpret regulatory requirements and support translation 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 supplier performance metrics; support corrective and preventive actions.
• Ensure accurate maintenance of compliance documentation, records, and reports.
• Contribute to continuous improvement initiatives to strengthen supplier compliance governance and effectiveness.

Qualifications

Education: Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or a related discipline (required). Advanced degree in a scientific or regulatory field (preferred).

Experience and Skills:

Required: Typically 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.

Preferred: 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).

Other:

Language: English, additional European language preferred. Travel: moderate regional; limited international travel. Certifications: Quality or Regulatory certifications preferred.

Required Skills: 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).