Job Description

General Summary:

The Associate Director, Biomarker Operational Quality will provide biomarker quality leadership and oversight across GxPs-related to research and development, implementation into clinical trials and potential commercialization of clinical biomarkers into IVDs. This leader will collaborate with business partners and GCP Operational Quality to drive quality outcomes and operational excellence.

The Associate Director will ensure that quality oversight activities maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs. This individual will also collaborate with the Biomarker Operations team to review and support the development of meaningful quality indicators and metrics to permit ongoing evaluation of process and quality system health and identification of risks.

This position reports directly to the Director, GCP Biomarker Operational Quality and works closely with other Quality team members to ensure appropriate GxP compliance and consistency in execution of fit-for-purpose Quality oversight across programs and products.

Key Duties and Responsibilities:

• Liaise with clinical functions and external parties including CROs, Vendors, and investigator sties to promote high level of quality and consistency across and within programs.

• Serve as a key technical resource for the GCP clinical execution function with responsibility of assuring quality risk management/ mitigation and adequacy and compliance with GCP regulatory requirements and guidance to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated

• 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.

• To drive process improvement, provide specialized knowledge and consultative guidance on GXP business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities.

• Participate in the evaluation and selection of GxP service providers.

• Develops risk-based audit plans for assigned programs, ensures audits are conducted in accordance with the plan, reviews audit reports, evaluates responses and CAPA plans in accordance with company standards and policies; assess impact of audit finding and other identified compliance risks to subject safety, data integrity and business operations and escalates significant compliance risks

• Manages and/or leads domestic and international audits for Clinical Investigators, to ensure compliance to ICH GCP, applicable regulations, and company standards.

Knowledge and Skills:

• In depth, specialized knowledge of ICH GCP E6 R2 and applicable global regulations and guidance for clinical development (e.g., FDA, EMA, MHRA, etc.)

• Significant experience with all phases of clinical trial development involving drugs, biologics, devices and drug/ device combinations (CLIA, CLSI, etc.)

• *Broad knowledge of CLIA regulations (42 CFR Part 493), and international equivalents, and other applicable guidance(s) ISO15189:2022, CLSI, etc.

• Demonstrated experience interpreting and applying GVP, GMP, GCP and GLP requirements across products to drive phase appropriate quality

• Demonstrated ability to collaborate effectively at all levels to drive delivery in a dynamic, fast paced environment.

• Excellent communication skills and a proven track record of influencing/building/promoting a culture of quality and excellence

• Strong problem solving and critical thinking skills required to make sound decisions

• Ability to work independently with minimal guidance, organizing and prioritizing work effectively for timeliness, accuracy and quality

• Possess a depth of scientific education and specialized knowledge to manage quality oversight for clinical trials; understands medical terminology, standards of care and disease states to assure the ethical treatment of subjects.

• Highly proficient in managing complex projects, achieving goals and deadlines

• Significant background in risk management principles and tools to manage risk and risk mitigation activities.

Education and Experience:

• B.S. in a scientific or allied health field

• Typically requires 8 years of experience or the required combination of education and experience

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid

Company Information