Meda Pharma GmbH & Co KG
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
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 Director, Regulatory Compliance role will make an impact.
Key responsibilities for this role include:
The Director, Regulatory Compliance will build and lead a newly established Global Regulatory Affairs (GRA) Compliance function, with responsibility for defining, embedding and continuously improving compliance across GRA. The role will partner closely with cross-functional stakeholders to monitor adherence to regulatory processes, lead audit and inspection readiness and learning, and own the development and evolution of the GRA Quality Management System (QMS).
Compliance
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Leadership and oversight on GRA compliance related topics, inspection & audit outcomes and trending.
Provision and as needed escalation of GRA compliance related topics to Senior Leaders
Oversight of authorities’ inspections and internal audits of GRA, incl. outcome & findings monitoring; tracking and monitoring of QE/CAPA related activities for GRA
Strong support in compiling and collecting information being presented to auditors
Close connection to and collaboration with cross-functional teams related to compliance in and outside GRA
Quality Management System (QMS)
Develop and Evolve the GRA Quality Management Systems (QMS), incl. GRA process hierarchy, procedure design, review and approval process, regular risk assessments, maintenance of a GRA Quality Plan, oversight on Management review of systems and a high-level definition of GRA roles and responsibilities
Regulatory Process Adherence Oversight
Oversight of GRA controlled Documents, review and sometimes approval of new GRA procedures
Monitoring process adherence in GRA incl. cross-functional involvement and strategic partnership on all aspects related to regulatory process adherence oversight
Oversight on procedures owned outside GRA but where regulatory is listed in the responsibility section and/or being trained on.
Close collaboration with the extended leadership team on all compliance and process adherence related topics, review and input into curricula and support for evaluation of training needs throughout GRA.
About Your Skills & Experience
Engaged leader with demonstrable experience of effective delivery in a complex matrix and multi-national environment and experienced in audit and inspection conduct in a European Market
Knowledgeable and engaged in all matters related to compliance in the pharmaceutical industry
Collaborative team player with excellent interpersonal and strategic influencing and cross-functional working skills.
Proven ability to partner successfully with other Regulatory functions, Quality, Safety, Medical and other internal stakeholders to achieve objectives.
Benefits at 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. Some of our benefits include the following on top of a competitive salary:
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.
