Executive Director, GCP Quality Assurance & Compliance

SystImmune, Inc.; Princeton (NJ); Hybrid; USD 240,000 - 300,000; Full time

Benefits offered by this job

100% paid employee premiums for health

STD & LTD

401(k) with 50% match up to 3%

5-year vesting schedule

15 PTO days per year

11 paid holidays

Job summary

SystImmune, Inc. seeks a meticulous Quality Assurance professional with deep GCP expertise to ensure our clinical trials and research activities meet regulatory standards. The role focuses on maintaining the integrity and ethical conduct of our studies across sites.

Ideal candidates have extensive QA in pharma/biotech, with ICH-GCP and FDA knowledge, and a track record in audits, CAPA, and training. Hybrid work welcomes strong collaboration and ongoing professional development.

Qualifications

• Bachelor's degree in life sciences or related field.
• 10+ years in quality assurance in pharma/biotech with GCP focus.
• SME in GCP, ICH-GCP, FDA regulations; audits/inspections experience.

Responsibilities

• Ensure clinical trial activities comply with GCP and ICH-GCP.
• Review protocols, investigator brochures, informed consent forms, and CSRs for GCP compliance.
• Plan, conduct, and participate in internal audits and external inspections.
• Develop and deliver internal training on GCP principles and regulations.
• Identify risks to GCP compliance and implement mitigation strategies.
• Maintain and improve the QMS and CAPA processes.
• Evaluate vendor performance to ensure GCP compliance.

Skills

GCP knowledge

Quality assurance

Audits & inspections

Cross-functional collaboration

Training & education

Education

Bachelor's degree in life sciences or related field

Job description

SystImmune, Inc. seeks a meticulous Quality Assurance professional with deep GCP expertise to ensure our clinical trials and research activities meet regulatory standards. The role focuses on maintaining the integrity and ethical conduct of our studies across sites.

Ideal candidates have extensive QA in pharma/biotech, with ICH-GCP and FDA knowledge, and a track record in audits, CAPA, and training. Hybrid work welcomes strong collaboration and ongoing professional development.