Compliance Manager

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 https://www.jnj.com

Job Function:
Legal & Compliance

Job Sub Function:
Enterprise Compliance

Job Category:
Professional

All Job Posting Locations:
Schaffhausen, Switzerland

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Regulatory Compliance Manager, to be located in Schaffhausen, Switzerland. 
Today, IM 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.
If you’re passionate about compliance and eager to make a difference in a collaborative environment, we want to hear from you! Join us and help us uphold our commitment to excellence!

Your key responsibilities


* Maintain the site’s inspection readiness by providing guidance in routine readiness activities, self-assessments, improvement initiatives, and projects related to Quality Systems.


* Assist in Front Office/Back Office activities during external audits, offering guidance and support in response to observations.


* Assess compliance in failure investigations, root cause identification, action plan development, and effectiveness monitoring.


* Drive compliance initiatives by implementing proactive projects.


* Champion Johnson & Johnson Standards and applicable pharmaceutical regulations, ensuring the site’s adherence while fostering collaboration across teams.


* Develop, coordinate, and execute the site’s internal audit program.


* Represent Regulatory Compliance in various forums and promote a culture of continuous improvement through performance metrics and best practices.


* Collaborate on independent audits and special assessments while refining compliance strategies.

Qualifications
Education:


* A minimum of a bachelor’s degree or equivalent experience in Science or related field.

Experience and Skills

Required: 


* Minimum of 7 years in a GMP-regulated environment, with at least 2 year focused on quality, manufacturing or regulatory compliance.


* In-depth understanding of compliance requirements related to medicinal products 


* Proven experience in performing GMP audits.


* Proven experience in preparing and supporting inspections.


* Strong analytical and interpersonal skills with a solution-oriented mindset.

Preferred:


* In-depth knowledge of aseptic technique and large molecule manufacturing


* Experien...