Senior Compliance Specialist / Senior Compliance Specialist

Johnson & Johnson is currently seeking a

Sr. Compliance Specialist (m/f/d)

to join our team located in Schaffhausen, Switzerland.

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, profoundly impacting health for humanity. Learn more at Johnson & Johnson.

Today, Johnson & Johnson Innovative Medicine Schaffhausen is one of the largest pharmaceutical manufacturers in Switzerland, supplying all the major global markets. The Schaffhausen facility is a strategic launch and growth site for Johnson & Johnson.

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

Are you interested in joining a diverse team and actively shaping the compliance of the site? Apply online using the form below for this exciting opportunity!

Key Responsibilities:

• Implement and execute the internal audit program at the site (schedule, agenda, prepare and conduct audits, report writing, review of internal audit investigation responses).
• Responsible for training and qualifying auditors.
• Facilitate and support external GMP audits and inspections (Health Authority, Customer), including the coordination of the inspection back room.
• Inspection Readiness: lead compliance walk-throughs, audit preparations, coaching 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:

• Education: A minimum of a Bachelor's Degree or equivalent experience in Science or a related field.
• Experience and Skills:
  • Required:
    • At least 5 years of related experience in a GMP-regulated industry and at least 1 year of regulatory compliance experience. Candidates with manufacturing, technical experience, and hands-on shop floor knowledge will also be considered.
    • 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).
    • Proficiency in German.
• Other: Domestic/International travel is possible (5%-10%). This is a Flex position that requires 3 days on site and 2 days remote, with exceptions during audit and inspection periods where on-site presence is needed. Other arrangements may be considered on a case-by-case basis with company approval.

What we offer:

Our employees are just as important to us as our customers. At Johnson & Johnson, we focus on long-term growth and enable successful careers with diverse pathways within our company. We strive to support you in reaching your full potential with us.

Working at Johnson & Johnson:

For over 130 years, diversity, equity, and inclusion (DEI) have been integral to our culture and business practices at Johnson & Johnson. Our commitment to respecting the dignity and diversity of all is embedded in our Credo.

We understand that our business's success relies on attracting top talent from a workforce that mirrors the diverse markets we serve globally, fostering an inclusive culture that values different perspectives and life experiences.

That is why we are committed to creating an inclusive environment where diverse backgrounds, perspectives, and experiences are valued. We aim for every individual to feel they belong and can reach their potential, regardless of their background.

Johnson & Johnson Family of Companies is an equal opportunity employer, 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.

We are offering a diverse position with a variety of responsibilities in a dynamic and complex international environment. If you are interested, please apply online using the form below.