Sr. Manager, CQ EOV

Sr. Manager, Commercial Quality – Economic Operator Verification (EOV)

Location:

Zuchwil, Switzerland or Hamburg, Germany.

Job Function:
Quality. Job Category:
People Leader.

• Provide strategic leadership and governance for Commercial Quality EOV activities, ensuring alignment with internal quality systems and global regulatory requirements.
• Lead, develop, and inspire a high‑performing Commercial Quality EOV team, including talent development, succession planning, and performance management.
• Oversee and ensure effective execution of quality events, including nonconformances, investigations, risk assessments, and corrective and preventive actions (CAPA), driving timely and sustainable outcomes.
• Act as a senior quality partner to Manufacturing, Supply Chain, Regulatory Affairs, and Commercial leaders to support product changes, transfers, launches, and lifecycle management activities.
• Lead readiness, execution, and follow‑up for internal audits, health authority inspections, notified body audits, and external assessments.
• Drive continuous improvement initiatives to enhance compliance, quality performance, and operational efficiency using risk‑based and data‑driven approaches.
• Represent Commercial Quality EOV in regional and global governance forums, contributing to enterprise quality strategy, policy development, and best‑practice sharing.
• Serve as a change leader, supporting organizational transformation initiatives and reinforcing a strong culture of quality and accountability.

• Education:
  
  Bachelor’s degree required in Engineering, Life Sciences, or a related scientific discipline. Master’s degree preferred.
• Experience:
  
  Minimum 10–12 years of progressive experience in Quality Assurance, Commercial Quality, or a regulated medical device environment, with increasing leadership responsibility.
• Leadership:
  Demonstrated experience leading and developing teams and/or managing complex, cross‑functional quality programs at a global or regional level.
• Technical:
  Strong working knowledge of quality management systems, risk management, post‑market surveillance, and commercial distribution quality processes.
• CAPA:
  Proven track record of leading investigations, nonconformances, and CAPA to effective and compliant closure.
• Stakeholder Influence:
  Ability to influence senior stakeholders and drive alignment across matrixed global organizations.
• Analytical:
  Strong analytical, problem‑solving, and decision‑making skills, with the ability to operate effectively in a dynamic environment.
• Preferred:
  Experience supporting Economic Operator Verification (EOV), product changes, or manufacturing‑to‑market quality interfaces.
• Regulatory:
  Familiarity with EU MDR, MDSAP, and other global regulatory requirements.
• Industry: Experience in orthopedic or implantable medical device products.
• Inspections:
  Experience leading or supporting regulatory inspections, health authority interactions, and notified body audits.
• Continuous Improvement:
  Knowledge of Lean, Six Sigma, and risk‑based quality approaches.
• Language:
  Fluent in English.
• Travel:
  Moderate international travel.
• Certifications:
  
  Quality‑related certifications (e.g., ASQ, ISO) preferred.

• Travel:
  Moderate international travel.
• Certifications:
  
  Quality‑related certifications preferred.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact the appropriate accommodation resource.