Regulatory Compliance Manager

vor 2 Wochen

Schaffhausen, Schweiz Johnson & Johnson Vollzeit

Johnson & Johnson is currently seeking an

Regulatory Compliance Manager (M/F/d)

to join our team 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

**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**:
Minimum Qualification

**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 years focused on quality, manufacturing or regulatory compliance.
- In-depth understanding of compliance requirements related to medicinal products
- 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
- Knowledge of small molecule manufacturing
- Experience performing internal audits (lead auditor certification is a plus)

Other:

- Very good communication in English, German skills are a plus.
- Occasional domestic/international travel (5%-10%).

This Flex position requires a minimum of 3 days on-site and 2 days remote, with on-site presence needed during audit and inspection periods. Other arrangements can be discussed on a case-by-case basis.

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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