General Position Summary:The Associate Director, Biomarker Operational Quality, provides leadership and oversight across GxP-regulated activities related to the research, development, and potential commercialization of clinical biomarkers, including their integration into clinical trials and transformation into in vitro diagnostics (IVDs). This individual works closely with internal stakeholders to ensure quality outcomes and operational excellence, driving proactive oversight and supporting continuous improvement initiatives.

This role collaborates with Biomarker Operations and Quality teams to develop and monitor quality indicators and metrics that assess process performance, quality system health, and emerging risks. The position also contributes to inspection readiness, audit strategy, and vendor quality oversight to support high standards of compliance and effectiveness.

Key Responsibilities:Responsibilities may include, but are not limited to:

• Partnering on quality oversight of preclinical and clinical activities (e.g., fit-for-purpose validations and associated processes) across therapeutic modalities.

• Contributing to regulatory document reviews (e.g., Briefing Books, INDs, IDEs, Trial Master Files), identifying potential compliance risks or gaps.

• Supporting the development of GCLP and GCP Biomarker vendor audit scopes and focus areas.

• Engaging in business initiatives related to procedures, systems, and regulatory tools that support non-clinical and clinical activities.

• Participating in cross-functional initiatives to improve compliance with applicable regulations, standards, and internal policies.

• Identifying potential compliance risks that could impact business objectives and implementing pragmatic solutions.

• Supporting proactive reporting and communication of significant quality issues in biomarker-related development activities.

• Contributing to inspection readiness activities, including quality assessments of GLP/GCP biomarker studies.

• Advising on audit strategy for biomarker vendors, systems, and processes.

• Collaborating with R&D vendor quality groups to assess vendor performance and risk.

• Participating in governance forums to provide input on quality metrics and risk-based insights.

• Designing and monitoring quality metrics specific to biomarker-related activities in collaboration with clinical, preclinical, and quality stakeholders.

• Communicating trends and key insights related to preclinical and clinical study quality to relevant stakeholders.

• Participating in due diligence and integration activities when needed.

Knowledge and Skills:

• Strong knowledge of applicable regulations and standards (e.g., CLIA [42 CFR Part 493], ISO15189:2022, CLSI).

• Proven ability to collaborate across departments and levels in a fast-paced, dynamic environment.

• Experience with quality metrics, dashboards, and continuous improvement initiatives.

• Excellent communication skills with a track record of promoting a culture of quality and compliance.

• Strong analytical and problem-solving skills to support sound decision-making.

Minimum Qualifications:

• Bachelor's degree in a scientific or allied health discipline.

• Typically requires at least 6 years of relevant experience, or an equivalent combination of education and experience.