Counsel, GxP Compliance

Viatris; United States; Remote; USD 151,000 - 314,000; Full time

Job summary

An established industry player seeks a Counsel for GxP Compliance to provide expert legal advice on quality processes in the pharmaceutical sector. This role involves counseling clients on regulatory compliance, developing corrective action plans, and engaging with cross-functional teams to enhance quality systems. With a focus on collaboration, the position offers the opportunity to make a significant impact in a dynamic environment. If you are a skilled legal professional with a passion for healthcare and compliance, this is the perfect chance to contribute to meaningful change.

Qualifications

• 7 years of experience in the pharmaceutical or biotechnology industry.
• Licensed to practice law in one or more jurisdictions.

Responsibilities

• Counsel clients on GxP and Quality processes for drug development.
• Assist with regulatory compliance and corrective action plans.

Skills

Legal Counseling

GxP Compliance

Regulatory Knowledge

Communication Skills

Interpersonal Skills

Conflict Resolution

Team Collaboration

Education

Juris Doctorate

Background in Science

Job description

Mylan Inc.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

• Access - Providing high quality trusted medicines regardless of geography or circumstance;

• Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

• Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here's how the Counsel, GxP Compliance role will make an impact:

Key responsibilities for this role include:

• 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.

The minimum qualifications for this role are:

• Juris Doctorate is required and 7 years of experience in Pharmaceutical or biotechnology industry as inside or outside counsel. Three to five years of technical expertise in manufacturing and GxP auditing preferred. Related experience/education may also be considered.

• Seven 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.

• This role may have remote flexibility.

• Proficiency in speaking, comprehending, reading and writing English is required.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $151,000 - $314,000.

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.

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. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

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