Associate Director, GCP & CQA Auditing

About the role

SystImmune Inc. is a dynamic clinical-stage bio-pharmaceutical company headquartered in Redmond, WA, with a mission to revolutionize cancer treatment by developing breakthrough therapeutic multi-specific antibodies and ADCs. The company has eight assets in ongoing clinical trials and a robust preclinical pipeline, committed to advancing innovative therapies from discovery through IND-enabling stages. The Associate Director, Clinical Quality Assurance (GCP/GVP) provides 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 role partners closely with Clinical Operations, Drug Safety/Pharmacovigilance, Regulatory Affairs, Biometrics, and external vendors to ensure effective implementation of quality systems, proactive risk management, inspection readiness, and continuous improvement initiatives, serving as a key quality advisor across development programs.

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

Qualifications

• 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

SystImmune is a stable, well-funded biotech company with a bright future, offering opportunities to learn and grow while making significant contributions to the company’s success.

• 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
• Short-term disability (STD) and long-term disability (LTD)
• 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only