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Viatris · 7 hours ago

Counsel, GxP Compliance

United States

Full-time

Remote

Senior Level

$151K/yr - $314K/yr

7+ years exp

Viatris is a healthcare company that aims to provide high quality trusted medicines worldwide. The Counsel, GxP Compliance role involves counseling clients on GxP and Quality processes, ensuring compliance with regulations, and supporting process improvements across various teams.

BiotechnologyHealth CareLife SciencePharmaceutical

Responsibilities

Responsible for counseling clients on a wide range of issues with focus on GxP and Quality processes for the development, manufacture, and distribution of drugs, biologics, medical devices, supplements, and cosmetics

Provide timely and effective counsel related to compliance with GxP regulations from various health authorities (e.g., FDA, EMA, TGA, Health Canada, WHO)

Assist with development of corrective action plans and responses following regulatory inspections and inquiries

Assist in developing materials for regulatory meetings and preparing teams participating in such meetings

Participate in committee meetings to review internal quality metrics and participate in site or project governance committees, as needed

Provide guidance on product quality incidents and post-marketing reporting obligations and actions

Work cross functionally with Quality, Regulatory, and other stakeholders to advise on and support process and systems improvements, including development of global quality policies and training materials

Prepare and edit written reports and communications for internal and external use related to regulatory and GxP compliance requirements and obligations

Monitor the external environment and advise teams on policy and regulatory developments related to GxP and related activities

Manage engagements with outside counsel to ensure effective and efficient use

Perform related duties as assigned

Qualification

Juris DoctorateGxP CompliancePharmaceutical Industry ExperienceLegal ExperienceGxP AuditingEnglish ProficiencyOral CommunicationWritten CommunicationInterpersonal SkillsConflict ResolutionTeam Collaboration