Senior Quality Assurance Manager (m/f/d)

Reposted 16 Days Ago
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Office, Machaze, Manica
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
The Senior Quality Assurance Manager ensures compliance and product quality, manages the Quality Management System, and liaises with regulatory authorities.
Summary Generated by Built In
Viatris Pharma GmbH

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via: 
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
Partnership – Leveraging our collective expertise to connect people to products and 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

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. 

Viatris is an Equal Opportunity Employer.

Top Skills

Gdp
Gmp
Quality Management System
Regulatory Requirements
Swiss Medical Devices Ordinance
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The Company
HQ: Canonsburg, PA
16,557 Employees

What We Do

Viatris is a global pharmaceutical company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer.

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