Manager- Clinical Quality Assurance

Location: Princeton, NJ (Hybrid, 3 days on-site 2 days remote)
Contract Length: 6-12 Months

Position Summary:

This position will be responsible for all QA oversight of GCP activities. The primary responsibilities will be to ensure quality and compliance of:

• Sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific, and current industry standards and practices)

• Non-clinical team on ensuring GLP studies are conducted in a compliant manner.

Responsibilities:

• Schedule, oversee and perform routine and non-routine quality assurance audits to include:

o Clinical investigator sites

o Animal testing sites

o Vendors

o Process, system, study project

o Document reviews to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines

• Provide GCP and GLP QA oversight and support internal staff.

• Assist Clinical Ops in the development of SOPs and other quality documents.

• Develop and implement detailed audit plans and yearly audit schedules.

• Ensure the timely and effective follow up of all identified or assigned quality issues

• Assist in preparing investigational sites for regulatory inspections.

• Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents.

• Conduct QA review of GLP reports.

• Schedule and/or execute yearly GCP training for staff.

• Assists with GCP training of study site personnel as needed.

Minimum Qualifications:

• Bachelor’s Degree in a scientific discipline. Alternatively, relevant education and job experience may be considered in absence of a Bachelor’s Degree.

• Minimum of 5 years in the Pharmaceutical industry with 2 years in GCP QA.

• Solid understanding of GCP, GLP and ICH clinical requirements.

• Experience with both domestic and international clinical studies.

• Able to travel domestically and internationally approximately 25% of the time .