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 Med Tech, 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 https://www.jnj.com/.

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 Johnson & Johnson strategic launch and growth site.

This is a phenomenal opportunity to be part of the team driving the site to compliance through proactive identification of gaps and risks.
Are you interested in joining a diverse team and actively shape the compliance of the site? Apply now for this exciting opportunity!

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

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. Other arrangements may be considered on a case-by-case basis and if approved by the Company.

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. We do everything we can to enable you to develop your full potential with us.

Working at Johnson & Johnson:
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
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.
We are offering you a diversified position with a variety of responsibilities in a dynamic and complex international environment. If you we have sparked your interest then please send us your complete online application (CV, cover letter) in English.