About this opportunity
SystImmune lists this Associate Director, GCP & CQA Auditing opportunity in princeton, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
This position requires a hybrid working model, with expectations of being in office 2-3 days a week at an office in Princeton, New Jersey (preferred location).
Company Overview:
SystImmune Inc. is a dynamic clinical-stage bio-pharmaceutical company headquartered in Redmond, WA. Our mission is to revolutionize cancer treatment by developing breakthrough-therapeutic multi-specific antibodies and ADCs. With eight assets in ongoing clinical trials and a robust preclinical pipeline, we are committed to advancing innovative therapies from discovery through IND-enabling stages.
Job Summary:
The Associate Director, Clinical Quality Assurance (GCP/GVP) is responsible for providing strategic leadership and oversight of Clinical Quality programs to ensure compliance with global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations, guidelines, and company standards.
This position partners closely with Clinical Operations, Drug Safety/Pharmacovigilance, Regulatory Affairs, Biometrics, and external vendors to ensure the effective implementation of quality systems, proactive risk management, inspection readiness, and continuous improvement initiatives. The Associate Director serves as a key quality advisor across development programs and contributes to the advancement of a culture of quality and compliance throughout the organization.
Quality Systems & Compliance
Provide oversight and guidance to ensure compliance with global GCP and GVP regulations, including FDA, EMA, MHRA, PMDA, NMPA, and ICH requirements
Support the development, implementation, and continuous improvement of the Clinical Quality Management System (QMS)
Lead quality risk management activities, including quality risk assessments and mitigation planning
Ensure quality processes remain aligned with evolving regulatory expectations and industry best practices
Audit Program Management
Develop and execute risk-based annual GCP/GVP audit programs
Lead and/or oversee internal, external, investigator site, vendor, CRO, and pharmacovigilance audits
Review audit findings, assess systemic impact, and ensure appropriate remediation activities are implemented
Identify compliance trends and recommend strategic quality improvements
Inspection Readiness
Lead inspection readiness activities across clinical development and pharmacovigilance functions
Support regulatory agency inspections and sponsor audits
Coordinate inspection preparation activities, including mock inspections and readiness assessments
Provide strategic guidance during regulatory inspections and ensure effective management of inspection responses
CAPA & Quality Event Management
Oversee investigations involving deviations, non-compliance events, inspection observations, and audit findings
Facilitate root cause analysis and ensure CAPAs are appropriately developed, implemented, and verified for effectiveness
Monitor quality events and CAPA metrics to identify trends and opportunities for improvement. Vendor Quality Oversight
Lead quality oversight activities for CROs, pharmacovigilance vendors, laboratories, technology providers, and other GCP/GVP service providers
Support vendor qualification, risk assessments, audits, and ongoing performance monitoring
Provide quality input during vendor selection and governance activities
Ensure outsourced activities maintain appropriate regulatory compliance and quality standards
Quality Metrics & Risk-Based Quality Management
Establish and monitor key quality metrics and compliance indicators
Analyze quality data to identify emerging risks, compliance trends, and systemic improvement opportunities
Support implementation of Risk-Based Quality Management (RBQM) strategies and Quality Tolerance Limits (QTLs)
Present quality metrics and compliance status to senior leadership
SOP Development & Training
Lead development, review, and lifecycle management of GCP, GVP, and Clinical Quality SOPs and associated procedures
Develop and deliver quality training programs
Provide quality consultation and mentoring to cross-functional teams
Promote a culture of quality, inspection readiness, and continuous improvement
Leadership & Strategic Partnership
Serve as a trusted quality advisor to clinical development teams
Lead cross-functional quality initiatives supporting organizational objectives
Mentor junior quality professionals and support development of departmental capabilities
Contribute to long-term Clinical Quality strategy, resource planning, and operational excellence initiatives
Qualifications/Requirements:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field required
8+ years of experience in Clinical Quality Assurance, Clinical Research, Pharmacovigilance, or related pharmaceutical/biotechnology functions
Minimum 5 years of direct GCP Quality Assurance experience
Demonstrated experience leading GCP audits, vendor audits, and inspection readiness programs
Experience supporting regulatory authority inspections (FDA, EMA, MHRA, PMDA, NMPA, or equivalent)
Experience within oncology clinical development strongly preferred
Experience working in global clinical development environments and managing outsourced service providers
Benefits:
Competitive salary and benefits package
Opportunities for professional development and career advancement
Work in a dynamic and collaborative environment at the forefront of clinical research
Contribute to meaningful projects that have the potential to improve patient outcomes and advance medical science
The hiring pay range for this position is $150,000 - $190,000 per year based on skills, education, and experience relevant to the role.
SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
Worksite address
princeton, NJ, 08543, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.