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Director regulatory compliance (process excellence)

Dublin
Viatris
Director
Posted: 31 January
Offer description

Meda Pharma GmbH 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 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.
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