Senior Quality Manager (Responsible Person) (f / m / d) - Part Time

As a member of the Cham and Global Quality Team, the Senior Quality Manager, Corporate Quality Excellence and Responsible Person (RP).

The position is a dual role which performs the required activities as Responsible Person for the authorization of Catalent for the import, export and foreign trade of medicinal products including routine QMS maintenance for the Cham facility.

The role will also support Global Quality & Compliance for the Corporate EU area. As part of the Corporate Quality Team, you will be required to work with and across multiple EU / US sites supporting Quality initiatives and process improvements.

Senior Quality Manager (Responsible Person) (f / m / d) - Part Time

Specific Duties, Activities, and Responsibilities :

• Responsible Person for import, export, and foreign trade pursuant to section 2, and section 3, of the Medicinal Products Licensing Ordinance ( “AMBV”; “SR” 812.212.1).
• Responsible to act as a Responsible Person on the Cham GDP licence in accordance with the Swiss Medic Requirements and Medicinal Products Licensing Ordinance (SR 812.212.1), , article 17, article 18, and article 23
• Responsible for the Cham Quality Management System, its compliance and continued effectiveness.
• Manage inspections by Regulatory Agencies, e.g., Swiss Medic
• Direct Supervision of Catalent Cham site and quality system
• The Responsible Person is authorized to decide independently from the management in his area of responsibility
• Responsible for the quality of the Cham facility in interaction with other Catalent sites and ensure the proper handling of medicinal products.
• Ensure that the medicinal products are distributed in accordance with the requirements under the Good Distribution Practice (GDP)
• Maintain internal audit process to ensure self-inspections are performed as per schedule for the site.
• Support EU sites on regulatory inspection readiness and inspection management including regulatory responses. Lead and manage with sites the regulatory response timeline and action implementation adherence.
• Work at Catalent sites to lead and support remediation activities within the Catalent network with a focus on continuous improvement and enhancement to the QMS.
• Experience to act as a subject matter expert on QMS and Quality Execution Excellence across the EU network (e.g., enhancement of systems / processes, quality standards etc)
• Coordinate with stakeholders in the development of process improvements within the network.
• Collaborate and foster cross-functional business relationships with other functional groups.
• Participate in Global Quality projects that enhance global compliance and support business objectives.
• Monitor and facilitate activities required to assure qualified status of existing and prospective suppliers in compliance with Global procedures and Regulatory requirements.

Qualification :

Why Join Us?

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

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Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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