Senior Source Regulatory Compliance Specialist, Supplier Auditor (m/f/d)

Stellenbeschreibung:

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

Umkirch, Germany

Job Description

Job Overview

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.

Key Responsibilities

Plan, execute, and document Supplier Audits and related Source Regulatory Compliance activities, including investigation approval and objective evidence review, to verify adherence to applicable regulatory and quality system requirements.
Partner with Supply Chain, Procurement, Quality, and Regulatory Affairs to execute compliant supplier qualification, lifecycle management, and audit readiness.
Interpret regulatory requirements and support translation into supplier compliance expectations.
Support internal audits, external audits, and health authority inspections related to supplier compliance.
Monitor compliance risks, supplier performance metrics, and audit trends; support corrective and preventive actions to address identified gaps.
Ensure accurate maintenance of supplier audit documentation, compliance records, and reports.
Contribute to continuous improvement initiatives to strengthen supplier compliance, governance and effectiveness.

Qualifications

Education

Bachelor's degree in Engineering, Life Sciences 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, Supplier Auditing, or related roles within the medical device regulated industry.
Working knowledge of global medical device quality and regulatory requirements impacting supplier operations, including quality system expectations for supplier controls.
Experience planning, supporting, or executing supplier audits, inspections, or compliance assessments in a regulated environment.
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.