Head of Quality Assurance

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.

• Access Providing high quality trusted medicines regardless of geography or circumstance;
• Leadership Advancing sustainable operations and innovative solutions to improve patient health;
• 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.

Every day we rise to the challenge to make a difference and here show the Head of Quality Assurance role will make an impact :

• Oversees and manages the quality related activities in Switzerland.
• Functions as contact person for all quality-related issues involving the entities mentioned above in the table.
• Responsible for following important elements as (list not exhaustive) :
• Ensures compliance with all applicable regulatory requirements and internal policies / SOPs across the affiliate and drives continuous improvement initiatives.
• Ensures the site operates in adherence to quality standards and objectives.
• Collaborates with cross-functional teams establishes quality metrics conducts audits and provides strategic direction to maintain and enhance product or service quality.
• Ensures the correct non-conformance handling of deviations complaints including respective CAPA activities and recalls.
• Accountable for the management and usage of all quality-related documents (e.g. SOPs specifications PQR Site Master File Technical Quality Agreements).
• Oversees the supplier qualification of (whereas audit management is delegated to global audit management) locally registered products (non-corporate products) and third-party services.
• Ensures the execution of self-inspection GDP-training management review and change control activities.
• Ensures proper storage and handling of release samples.
• Ensures proper storage and archiving of the quality management documentation as specified in Good Documentation Practice.
• Leading and Management of quality assurance employees by agreeing on specific goals coaching motivation; individual assessment and further development of the employees.
• Budget and cost center control.

For this role we are looking for a candidate who has an effective combination of the following qualifications, skills and experiences :

• A Masters degree or equivalent with a specialization in natural science or pharmaceutical related / equivalent area is required.
• An 8 or more years of experience Experience in Regulatory Affairs quality assurance matters and as a Swiss FvP or deputy FvP is required.
• Extensive experience in regulatory affairs and deep knowledge of Swiss national regulations and regulatory guidance policies and procedures as well as knowledge of EU regulation.
• Broad functional knowledge of pharmaceutical sciences and pharmaceutical industry.
• Experience of managing a team and leading a department is essential.
• Experience of working cross-functionally with other company functions.
• Proven track with Swiss medic interactions including but not limited to Scientific Advice Meetings.
• Fluency in German and advanced proficiency in English are essential requirements.
• Position is located in Switzerland (Viatris offices in Steinhausen).

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.

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 and also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

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 Viatris.

Corporate social responsibility is fundamental to the Viatris…