Associate Director, GVP Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Driving the implementation of the Global Quality vision, policies, processes, and decisions.

• Collaborate with stakeholders to pinpoint, convey, and address compliance risks.

• Continuously improve relationships with key stakeholders and leaders throughout the organization.

• Support and propel the execution of quality and compliance projects and goals.

• Remain informed about regulations and suggest proactive compliance adjustments when necessary.

• Implement GVP Compliance processes and best practices.

• Conduct GVP audits and aid in the successful execution of the Global GVP Audit Program.

• Serve as a core team member for GVP compliance on regulatory inspection teams and assist in mock readiness initiatives.

• Offer insights to consistently enhance the GVP Compliance Audit Program.

• Assist in updates to the Pharmacovigilance System Master File (PSMF).

• Contribute to the Risk Evaluation and Mitigation Strategies (REMS) compliance program.

• Help build a team committed to GVP compliance while fostering a culture of collaboration and respect.

• Mentor and assist in the development of junior staff to help them realize their full potential.

⛳️ Requirements

• Over 8 years of experience in a regulated healthcare industry, including a role focused on quality and compliance.

• Proficient understanding of FDA, EMA, and global PV regulations, including the application of Good Pharmacovigilance Practices (GVP), ICH, and GCP regulations.

• Experience in Pharmacovigilance (PV) within Quality and Compliance.

• Experience in executing or managing Health Authority Inspections.

• Experience in executing or managing R&D Audits and the GVP Audit Program.

• Proven ability to identify optimal strategies for implementing a GVP audit program in collaboration with internal auditors and external consultants.

• Familiarity with navigating and comprehending a quality management system.

• Core competencies in strategic thinking, agility, prioritization, communication, and decision-making.

• Excellent verbal, written, and oral communication skills, with the ability to present to Senior Leadership.

• Strong computer proficiency, including experience with the MS Suite of tools and interaction with Quality Management Systems.

🏝️ Benefits

• Equal Opportunity Employer/Veterans/Disabled