Associate Director, Early Development Quality

Overview

The Associate Director, Early Development Quality provides strategic, upstream quality leadership across nonclinical development programs, with a focus on de-risking study design, biomarker strategies, and external laboratory partnerships to protect downstream clinical and regulatory outcomes. The position leads risk-based oversight of external laboratories and vendors in alignment with GLP, OECD, and global regulatory expectations, while proactively identifying and mitigating risks that could impact data integrity, inspection readiness, or agency review during IND and NDA submissions.

This role partners closely with Research, Nonclinical, Biomarker, Bioanalytical, Regulatory, and Clinical Quality stakeholders to embed quality and risk management early in program strategy and execution.

This position will be located within the US and can be hybrid, onsite, or remote.

• Sets the strategic quality oversight direction for internal and outsourced laboratory activities supporting nonclinical development (GLP and non-GLP), including toxicology, bioanalytical, and biomarker data supporting IND, CTA, and NDA submissions.
• Provides upstream scientific and quality risk oversight for nonclinical programs by partnering with Research, Nonclinical Project Teams, Biomarker, Bioanalytical, Regulatory, and Nonclinical Writing functions to evaluate study strategies, contribute to protocol design, and proactively identify risks that could impact data integrity, translational interpretation, or downstream clinical and regulatory outcomes.
• Acts as a strategic quality partner in biomarker development and evaluation, ensuring fitness for purpose, analytical robustness, and data integrity to de-risk nonclinical studies and reduce the likelihood of downstream GCP or regulatory challenges.
• Establishes and maintains quality oversight of external laboratories and vendors (e.g., test facilities, CROs, specialty labs, bioanalytical and biomarker partners, clinical laboratories) through risk-based qualification, governance, ongoing performance monitoring, and surveillance.
• Leads the design and execution of a global, risk-based vendor oversight and audit strategy aligned with GLP, OECD, ICH, and regulatory expectations, ensuring that qualification, surveillance, and audit planning are driven by inherent and emerging risk.
• Develops and maintains structured risk identification frameworks for new and existing vendors, enabling consistent qualification decisions, defensible oversight, and inspection-ready documentation.
• Serves as an upstream risk intelligence partner to R&D Quality and Regulatory functions, translating nonclinical and GLP risks into potential agency questions, inspection vulnerabilities, and mitigation strategies relevant to IND and NDA submissions.
• Leads quality governance and escalation for GLP vendor-related issues, including oversight of quality events, investigations, CAPAs, and executive-level risk visibility as appropriate.
• Provides strategic quality input into CRO and vendor operating models, evaluating process maturity, data governance, systems, and opportunities to strengthen compliance, inspection readiness, and operational effectiveness.
• Advises on continuous improvement of the Quality Management System to better support early development and research activities while maintaining regulatory robustness.
• Partners with Legal and Procurement to ensure contracts and agreements appropriately reflect GLP/OECD obligations, oversight expectations, data integrity requirements, and inspection readiness responsibilities.

• Educated preferably in life sciences (technology, biological science, pharmacy or other health-related discipline preferred) or equivalent qualification or work experience. Master s degree in a science, technology or industry-related discipline, preferred.
• Minimum of 10 years of relevant experience, inclusive of bioanalytical and toxicology subject matter, as it relates to GLPs, GCPs and GCLPs.
• Direct experience in the field of assay development and validation and familiar with biomarker-based assays (e.g., PCR, ELISA, FISH) is preferred.
• Prior experience in…