Quality Manager

vor 4 Wochen

Cham, Schweiz Catalent Vollzeit

We are currently looking for a** Quality Manager (Responsible Person) **to maintain oversight and RP duties at our Cham facility. This is a dual role which will report into the VP Execution Excellence.

Part of this role will be to maintain the RP duties at the Cham facility and the other part of the role as a member of the Execution Excellence team.

The position also requires the applicant to perform the required activities as Responsible Person for the authorization of Catalent for the import, export and foreign trade of medicinal products.
The position will perform Execution Excellence initiatives, continuous improvement across the business and the quality and regulatory compliance at the Cham facility.

**The Role**
- Responsible Person for import, export and foreign trade pursuant to section 2, Art. 9-10 and section 3, Art.13-14 of the Medicinal Products Licensing Ordinance (_Arzneimittel-Bewilligungsverordnung_ “AMBV”; _Classified Compilation of Federal Legislation_ “SR” 812.212.1).
- Manage inspections by Regulatory Agencies, e.g. Swiss Medic.
- 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.
- Collaborate and foster cross-functional business relationships with other functional groups such as Procurement and Supply Chain.
- Manage quality initiatives, generate routine performance metrics and assessments using risk-based methodologies.
- Monitor and facilitate activities required to assure qualified status of existing and prospective suppliers in compliance with Global procedures and Regulatory requirements.
- Perform supplier qualification activities and audits as required to maintain the approved supplier list for Cham.
- Manage follow-up activities to external audits including identification of root cause, risk assessment, and providing feedback on potential resolution.
- Knowledge and understanding of the following principles and guidelines: EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices.
- Experience with quality system audits within the Pharmaceutical/Medical Device industry.
- Experience working in a role relating to external supply in the pharmaceutical or medical device industry.
- Proven ability to identify, collaborate, and resolve compliance issues
- Strong process improvement mindset, Strong strategic business perspective and critical thinking capability
- Ability to influence and make recommendations to various departments and collaborate with the Operational Supply team (customer services and Operations)
- Strong interpersonal and communication skills and the ability to work across all levels of the organisation in accordance with the company's core values.
- Ability to travel both domestic and abroad to Catalent sites and supplier locations; Up to 20% travel.
- Fluency in English is required
- Eligibility to act as Responsible Person and within travelling distance of the site

**Position benefits**
- What we offer is an exciting role, a chance to grow and learn new skills in a global company
- Defined career path and annual performance review and feedback process
- Competitive salary, bonus and various company benefits

**Catalent’s standard leadership competencies that are used to interview and for Performance & Development**:

- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops

**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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and v

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