Head of Quality Assurance

Location: Indiana

Head of Quality Assurance page is loaded## Head of Quality Assurance locations:
Zug, Zug, Switzerland time type:
Praca na pełny etatposted on:
Opublikowano wczorajjob requisition :
R5665439

Viatris Pharma GmbHW Viatris postrzegamy opiekę zdrowotną taką, jaką być powinna, a nie taką jaka jest. Działamy odważnie i mamy wyjątkowe uwarunkowania, dzięki czemu stanowimy źródło stabilności w świecie zmieniających się potrzeb zdrowotnych. Viatris umożliwia ludziom na całym świecie zdrowsze życie na każdym jego etapie Osiągamy to poprzez (via):
* Dostęp* – dostarczanie pacjentom wysokiej jakości leków, cieszących się powszechnym zaufaniem, w czasie i miejscu, w jakim ich potrzebują;
* Przywództwo* – podejmowanie zrównoważonych działań i opracowywanie innowacyjnych rozwiązań w celu poprawy zdrowia pacjentów; oraz
* Partnerstwo* – wykorzystanie wspólnej wiedzy w celu dostarczenia naszych produktów i usług.

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
** Every day, we rise to the challenge to make a difference and here’s how 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.
** 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:  
* A Master’s 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…