1100 Mylan Pharmaceuticals Inc.
Head of Quality Assurance page is loaded## Head of Quality Assurancelocations:
Zug, Zug, Switzerlandtime type:
Temps pleinposted on:
Offre publiée aujourd'huijob requisition id:
R5665439Viatris Pharma GmbHChez 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**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 with Swissmedic 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 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.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 **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 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.Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer. En intégrant les atouts de ces deux entreprises, y compris notre main-d’œuvre mondiale d’environ 45 000 personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances.
Nous croyons aux services de santé comme ils devraient l’être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie. Et parce que nous croyons fermement qu’un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d’excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin. #J-18808-Ljbffr
Zug, Zug, Switzerlandtime type:
Temps pleinposted on:
Offre publiée aujourd'huijob requisition id:
R5665439Viatris Pharma GmbHChez 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**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 with Swissmedic 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 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.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 **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 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.Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer. En intégrant les atouts de ces deux entreprises, y compris notre main-d’œuvre mondiale d’environ 45 000 personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances.
Nous croyons aux services de santé comme ils devraient l’être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie. Et parce que nous croyons fermement qu’un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d’excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin. #J-18808-Ljbffr