Counsel - GxP Compliance

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March 1

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Viatris

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Pharmaceuticals • Healthcare Insurance

Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

10,000+ employees

Founded 2020

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Responsible for counseling clients on GxP and Quality processes • Provide timely counsel related to compliance with GxP regulations • Assist with development of corrective action plans and responses following regulatory inspections • Develop materials for regulatory meetings and prepare teams for such meetings • Participate in committee meetings to review internal quality metrics • Provide guidance on product quality incidents • Work cross functionally with Quality, Regulatory, and other stakeholders • Prepare and edit written reports and communications for regulatory compliance • Monitor external environment and advise teams on policy developments • Manage engagements with outside counsel • Perform related duties as assigned

🎯 Requirements

• Juris Doctorate is required • 7 years of experience in Pharmaceutical or biotechnology industry as inside or outside counsel • 3-5 years of technical expertise in manufacturing and GxP auditing preferred • 7 years of Legal experience advising clients directly or under the supervision of lawyers • Licensed to practice law in one or more jurisdictions is required • Exceptional oral and written communication skills, including strong presentation capabilities • Strong interpersonal and conflict resolution skills • Ability to work in a collaborative, team-oriented environment • Background/education in science related discipline is preferred • Proficiency in speaking, comprehending, reading and writing English is required

🏖️ Benefits

• Competitive salaries • Benefits • Inclusive environment