GCP Operational Quality Associate Director

·Partners with appropriate quality/compliance oversight of preclinical and clinical activities (fit-for-purpose validations and associated processes) across modalities in collaboration with Clinical Biomarkers and with other internal stakeholders in the business and Quality

·Contributes in Regulatory Document reviews, including BBs, INDs, IDEs, and TMFs, identifying any potential risks or gaps.

·Provides input in development of requested and for-cause GCLP and GCP Biomarker audit scope/focus for vendor audits.

·Supports business initiatives involving processes, procedures, regulations and tools intended to support non-clinical activities.

·Participates in strategic cross-functional initiatives to improve compliance to regulatory requirements, standards and internal Vertex policies.

·Identifies and anticipates potential compliance issues that may impact the ability to meet business goals; develops and implements methods of improvement and resolution in a pragmatic and effective manner.

·Contributes to proactive reporting of significant quality issues related to Vertex Preclinical product development, ensuring an aligned Quality point-of-view is represented.

·Contributes to proactive inspection readiness activities for processes that impact product development, including conducting inspection readiness quality assessments of GLP/GCP Biomarker studies, as requested.

·Serves in an advisory/consultative role in the development of audit strategy for GLP/GCP Biomarker vendors, processes and systems.

·Participates in engagement with R&D vendor quality to provide input for vendor performance and vendor risks.

·Serves as a key contributor to governance meetings, collaborating with business and quality stakeholders to contribute to agenda topics and provide meaningful metrics.

·Collaborates with Clinical and Preclinical stakeholders and quality partners to design appropriate quality metrics related to Biomarker activities.

·Ensures timely and effective communication of summary trending and other insights on the quality of delivery in preclinical/clinical studies to relevant business and quality partners and in relevant forums (e.g. Integrated Risk Teams)

·May participate in Due Diligence and integration activities as appropriate.

• Support Research staff by providing training on applicable Vertex policies/guidance and procedures with emphasis on functions generating non-GxP research intended for use in regulatory filings.
• Conduct Research QA (RQA) review of non-GxP protocols/reports intended to be used in regulatory submissions, to ensure clarity, consistency and alignment with Vertex and regulators expectations.
• Ensures appropriate communication, and where necessary escalation, of the outcomes of quality assessments including the identification of trends and action items to meet Vertex Research needs.
• Assist in development of presentations and training.
• Assist with oversight and management of complex projects to ensure milestones are met.
• Collaborates with business stakeholders and quality partners to develop meaningful quality metrics.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]