Counsel, GxP Compliance

Role Summary

Counsel, GxP Compliance responsible for counseling clients on a wide range of GxP and Quality processes related to the development, manufacture, and distribution of drugs, biologics, medical devices, supplements, and cosmetics. Provide timely legal counsel on GxP regulatory compliance from health authorities. Collaborate with Quality, Regulatory, and other stakeholders to advise on process and system improvements and to prepare regulatory materials and responses.

Responsibilities

• Counsel clients on GxP and Quality processes for development, manufacture, and distribution of pharmaceuticals and related products.
• Provide timely guidance on compliance with GxP regulations from health authorities (FDA, EMA, TGA, Health Canada, WHO, etc.).
• Assist with corrective action plans and responses after regulatory inspections and inquiries.
• Develop materials for regulatory meetings and prepare teams participating in such meetings.
• Participate in committee meetings to review internal quality metrics and governance.
• Provide guidance on product quality incidents and post-marketing reporting obligations.
• Collaborate cross-functionally with Quality, Regulatory, and other stakeholders to support process and system improvements, including global quality policies and training materials.
• Prepare and edit written reports and communications related to regulatory and GxP compliance.
• Monitor the external regulatory environment and advise teams on policy developments related to GxP.
• Manage engagements with outside counsel to ensure effective and efficient use.
• Perform related duties as assigned.

Qualifications

• Required: Juris Doctorate 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 be considered.
• Required: Seven years of legal experience advising clients directly or under the supervision of lawyers.
• Required: Licensed to practice law in one or more jurisdictions.
• Required: Exceptional oral and written communication skills, including strong presentation capabilities.
• Required: Strong interpersonal and conflict resolution skills; ability to work in a collaborative, team-oriented environment.
• Preferred: Background/education in science-related discipline.
• Preferred: Remote work flexibility.
• Required: Proficiency in English (speaking, reading, writing).

Education

• Juris Doctorate
• License to practice law in one or more jurisdictions
• Science-related background encouraged

Additional Requirements

• Remote work flexibility may be possible.