Lead Investigator – GMP Compliance (Remote / Yardley, PA)

Industry: Pharmaceutical / CDMO / Regulatory Compliance

About the Role

A global pharmaceutical and contract development organization is looking for a Lead Investigator to drive and maintain Good Manufacturing Practice (GMP) compliance across its U.S.-based manufacturing and distribution sites. This role is crucial to ensuring internal procedures and practices meet regulatory expectations across multiple regulatory bodies and standards (including FDA, EMA, and Health Canada).

The Lead Investigator will take ownership of the internal audit program, collaborate with site-level quality teams, provide GMP-related training, and support third-party and regulatory inspections. This role reports to the Senior Director of Quality and Corporate Compliance.

Key Responsibilities

• Audit Oversight: Design and manage a robust internal and vendor audit program that aligns with federal and international GMP regulations.
• Inspection Support: Act as a lead during internal and external inspections, including regulatory agency audits; support preparation, execution, and post-inspection responses.
• Training & Development: Train site-based auditors and Subject Matter Experts (SMEs) on compliance expectations and audit readiness.
• Risk Management: Identify gaps in compliance and develop mitigation strategies in collaboration with site leadership.
• Continuous Monitoring: Track and incorporate updates in global regulatory guidance into internal procedures.
• Reporting: Deliver clear, structured compliance reports to senior leadership, highlighting audit outcomes, trends, and improvement areas.

Ideal Candidate Profile

Education & Credentials:

• Bachelor’s degree in a scientific discipline (Master’s or relevant certifications in compliance or auditing is a plus).

Experience & Skills:

• 10–15 years of experience in GMP auditing and compliance within pharmaceutical or life science sectors.
• Prior experience as a regulatory investigator (FDA, EMA, Health Canada) highly preferred.
• Strong knowledge of U.S. and international GMP standards, compendia requirements, and procedural controls.
• Demonstrated ability to lead audit teams, conduct complex investigations, and develop strategic compliance initiatives.
• Excellent communication, analytical, and decision-making skills with a clear understanding of ethical business practices.
• This opportunity offers the chance to shape compliance frameworks across a diverse portfolio of operations, supporting innovation and quality within a globally regulated environment.

This opportunity offers the chance to shape compliance frameworks across a diverse portfolio of operations, supporting innovation and quality within a globally regulated environment.