Senior Director - GLP, Biomarkers and Research Quality

Vertex Inc.•Boston, MA

19h•$215,000 - $322,400•Hybrid

About The Position

This role has overall accountability for strategic leadership and oversight of the end-to-end quality assurance strategy for proactive, risk-informed, and sustainable quality oversight and compliance with regulatory expectations across Vertex processes for clinical evidence generation and product vigilance.

Requirements

M.S. (or equivalent degree) and 10 +years of relevant work experience
B.S. in a scientific or allied health field (or equivalent degree) and 15+ years of relevant work experience
relevant comparable background

Nice To Haves

Embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.
Seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Responsibilities

Serves as a strategic partner to functional leaders across product modalities responsible for Research (including both non-regulated and GLP work), Biomarker Development, and Diagnostics in assuring appropriate quality/compliance oversight of processes and systems supporting effective delivery of these programs and the rigor and integrity of associated data.
Defines strategy for and oversees tactical execution strategic plan by direct reports to provide effective oversight of research, assay development in support of pre-clinical and clinical research, GLP animal studies, in vitro diagnostic development, and all R&D vendors. Assures operational quality activities are informed by risk and assure the integrity of data submitted to regulatory authorities and in external forums.
Responsible for assuring that key research & pre-clinical studies (internal and external) are performed in accordance with good scientific practices, good laboratory practices, Vertex policies and procedures and relevant local, regional, and international requirements.
Leads an operational quality team responsible for identifying and anticipating potential compliance issues that may impact the ability to meet business goals, developing and implementing methods of improvement and resolution in a pragmatic and effective manner.
Oversees effective, timely, and appropriate identification, remediation, and escalation of quality issues in key Research, GLP, Biomarker, IVD and vendor governance-related activities across Vertex.
Provides periodic updates on the overall health of Research, GLP, Biomarker, and IVD development-related processes and systems to functional leaders across Research, Biomarker Development, and Diagnostics.
Oversees and assures timely and effective communication of summary trending and other insights on the quality of delivery in research, preclinical, biomarker, IVD work, and vendor performance to relevant business and quality leaders and in relevant forums.
Oversees Inspection Readiness activities in collaboration with business and Quality Assurance partners related to research, GLP, biomarkers, IVD development activities.
Chairs relevant operational governance meetings (e.g. QLT).
Serves as the R&D Quality lead and oversees and guides staff participating in strategic cross-functional initiatives (e.g. Research Ethics, TPRM) to improve quality, data integrity, and compliance to regulatory requirements and standards, ensuring a aligned Quality point-of-view is represented.
Maintains an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Research, GLP, Biomarker, and IVD activities.
Drives and oversees implementation of new and evolving regulatory requirements related to areas of responsibility.
Leads and/or participates in industry forums and external initiatives related to areas of responsibility to influence policy development related to oversight of these activities, as aligned with functional leadership and Vertex interests.
Provides strategic direction, oversight, coaching and mentoring to direct reports.