Senior Manager, GCP Quality Assurance
Job in
Trenton, Mercer County, New Jersey, 08628, USA
Listed on 2026-07-23
Listing for:
EPM Scientific
Full Time
position Listed on 2026-07-23
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
Job Description & How to Apply Below
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.
- 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.
- 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.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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