Senior Manager, GCP Quality Assurance

Senior Manager, GCP Quality Assurance

Location: Greater New Jersey Area | Hybrid

A growing biopharmaceutical organization is seeking a Senior Manager, GCP Quality Assurance to support global clinical development programs. This individual will play a key role in ensuring clinical research activities are conducted in compliance with applicable regulations, industry standards, and quality expectations.

Key Responsibilities

• Partner with clinical development teams to provide GCP quality and compliance support across clinical programs.
• Support quality oversight activities for CROs, vendors, and external partners.
• Identify compliance risks and collaborate with stakeholders to implement appropriate mitigation strategies.
• Participate in audit activities, including vendor, site, and process audits.
• Assist with inspection readiness efforts and the management of quality findings and corrective actions.
• Provide guidance on GCP regulations, industry expectations, and quality best practices.
• Contribute to the ongoing improvement of quality systems, processes, and compliance programs.

Qualifications

• Bachelor's degree in Life Sciences or a related scientific discipline.
• 5+ years of experience within GCP Quality Assurance, Clinical Quality, or Clinical Compliance.
• Working knowledge of global GCP regulations and industry standards.
• Experience supporting audits, inspections, and quality oversight activities within clinical development.
• Strong communication, collaboration, and problem-solving skills.
• Ability to work effectively in a cross-functional and fast-paced environment.

Preferred Experience

• Background supporting clinical trials within the pharmaceutical, biotechnology, or life sciences industry.
• Experience partnering with external vendors and contract research organizations (CROs).
• Familiarity with risk-based quality management and clinical quality systems.

This is an excellent opportunity to join a growing organization and have a meaningful impact on the quality and compliance of innovative clinical development programs.