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Senior quality assurance manager (m/f/d)

Bern
Viatris
Inserat online seit: 29 Mai
Beschreibung

Senior Quality Assurance Manager (m/f/d) page is loaded Senior Quality Assurance Manager (m/f/d) Postuler locations Zug-Office time type Temps plein posted on Offre publiée hier job requisition id R5659315 Viatris Pharma GmbH Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs:
Accès : En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.
Leadership : En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.
Partenariat : En valorisant notre expertise collective afin de donner accès à tous à nos produits et services.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
As Senior Manager Quality Assurance and Deputy QP (FvP), you will play a key role in ensuring regulatory compliance and product quality across several Swiss legal entities. Your main responsibilities include:
Acting as Deputy QP (FvP), including batch disposition, recalls, and ensuring GDP-compliant distribution

Leading and maintaining the local Quality Management System (QMS) in line with GMP/GDP standards

Serving as primary quality contact for Swissmedic, cantonal authorities, and external partners

Conducting management reviews, self-inspections, and release of reworked batches/products

Acting as Person Responsible for Regulatory Compliance (PRRC) under the Swiss Medical Devices Ordinance

Managing responsibilities related to narcotics and controlled substances according to Swiss regulations

Handling deviations, complaints, CAPA activities, and product recalls

Approving and maintaining quality-relevant documentation (SOPs, PQRs, Technical Quality Agreements)

Supporting supplier qualification and overseeing training activities

About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
University degree in pharmacy or a scientific discipline (e.g., chemistry, biology)

8+ years of experience in the pharmaceutical industry, including minimum 5 years in Quality Assurance

Proven experience as Swiss QP (FvP) or Deputy QP (minimum 3 years)

In-depth knowledge of regulatory requirements (TPA, MPLO, GDP, GMP, BetmG)

Strong decision-making and communication skills, able to act independently and responsibly

Fluency in English and German (spoken and written); French is a plus

Experience in liaising with Swissmedic and international regulatory authorities is an advantage

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Why Viatris?
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility
Chez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.

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