Senior Quality Assurance Manager (m/f/d)
Senior Quality Assurance Manager (m/f/d)
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1 Vacancy
Job Description
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 were 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 youre excited about this role but your past experience doesnt 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 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 Viatris we offercompetitivesalaries benefitsandan 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.
Required Experience:
Manager
Employment Type
Full-Time
