Director Global Regulatory Compliance (Process Excellence)

Director, Regulatory Compliance

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.

Key responsibilities include:

• Compliance 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 GRA 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.

Qualifications & 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

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Viatris is an Equal Opportunity Employer.