Senior Compliance Specialist

Vor 2 Tagen

Schaffhausen, Schweiz Johnson & Johnson Vollzeit

Job Description - Senior Compliance Specialist (2406220322W)

Senior Compliance Specialist (m/f/d)

Johnson & Johnson is currently seeking a Sr. Compliance Specialist to join our team located in Schaffhausen, Switzerland.

This is a phenomenal opportunity to be part of the team driving the site to compliance through proactive identification of gaps and risks.

Key Responsibilities:

  • Implement and execute internal audits program at the site (schedule, agenda, prepare and conduct audit, report writing, review of internal audits investigation responses).
  • Responsible for training and qualifying auditors.
  • Facilitate and support external GMP audits and inspections (Health Authority, Customer), including the coordination of inspection back room.
  • Inspection Readiness: lead compliance walk-throughs, audit preparation, coaching the SMEs.
  • Provide compliance subject matter expertise to the manufacturing site, including identifying changes in regulations that impact procedures and current practices.
  • Implement compliance initiatives and projects at the site, in alignment with Global Innovative Medicine Regulatory Compliance (IMRC).

Qualifications:

A minimum of a Bachelor's Degree or equivalent experience in Science or related field.

Experience and Skills:

Required:

  • At least 5 years related experience in a GMP-regulated industry and at least 1 year of regulatory compliance experience.
  • Experience preparing, handling and/or supporting inspections.
  • Strong analytical skills and ability to clearly articulate issues.
  • Excellent interpersonal skills, able to quickly build credibility with the site and within the Quality and Compliance community.
  • A creative, flexible approach to new challenges

Preferred:

  • Expertise on Health Authority and Pharma Quality System regulations, with the ability to relate these to business/quality issues.
  • Experience performing internal audits is strongly preferred (lead auditor certification).
  • German knowledge.

Other:

Domestic / International travel is possible (5%-10%). This is a Flex position that requires 3 days on site, and 2 days remote, with exception of audit and inspection period, where on site presence is needed.

What we offer:

Our employees are just as important to us as our customers. At Johnson & Johnson, we like to think long-term and enable successful careers with interesting career paths within our company.

Working at Johnson & Johnson:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

If you are an individual with a disability, please check our page for information on how to request an accommodation.

If you have sparked your interest, please send us your complete online application (CV, cover letter) in English.

Primary Location

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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