About this role
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications.
Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. 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.
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.