Description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, 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 discover and 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.

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.

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).

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

Associate Director, Clinical QA

Description

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