Associate Director, Clinical QA

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).

About the Company

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.

Responsibilities

• 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

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
• 100% paid employee premiums for medical, dental, and vision insurance
• Short-term and long-term disability coverage
• 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

Pay

The hiring pay range for this position is $150,000 - $190,000 per year based on skills, education, and experience relevant to the role.