Posted:
Tuesday, 01 April 2025
Valid Thru:
Thursday, 01 May 2025
Index Requested on:
04/01/2025 13:45:36
Indexed on:
04/01/2025 13:45:36
Location: Schaffhausen, SH, , CH
Industry:
Advertising and Public Relations
Occupational Category:
11-9000.00 - Management
Type of Employment: FULL_TIME
Johnson and Johnson is hiring!
Description:
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 & ComplianceJob Sub Function:
Enterprise ComplianceJob Category:
ProfessionalAll Job Posting Locations:
Schaffhausen, SwitzerlandJob 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
Experience performing 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.
Responsibilities:
Please review the job description.
Educational requirements:
Desired Skills:
Please see the job description for required or recommended skills.
Benefits:
Please see the job description for benefits.