Senior Manager Biomarker Operational Quality (contract) 26295

Job Description

Biomarker Operational Quality Senior Manager provides Biomarker quality leadership and oversight across GxPs-related to research and development, implementation into clinical trials and potential commercialization of clinical biomarkers into IVDs. The incumbent will collaborate with business partners and GCP Operational Quality to drive quality outcomes and operational excellence, through supporting operational management oversight for these areas.

 

The Senior Manager will ensure that quality oversight activities maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs. The Associate director, Biomarkers Operational Quality 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 work closely with other Quality members to ensure appropriate GxP compliance and consistency in execution of fit-for-purpose Quality oversight across programs and products.

 

The ideal candidate will have extensive experience in a matrixed environment and in a larger organization as well as be a subject matter expert in a diverse array of clinical labs.  They should have companion diagnostic (CDx) GMP & QA experience.

 

A strong QA background with an understanding of Biomarkers and Medical Devices

 

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• 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.

 

Knowledge and Skills:

 

• Broad knowledge of CLIA regulations (42 CFR Part 493), and international equivalents, and other applicable guidance(s) ISO15189:2022, CLSI, etc.
• Demonstrated ability to collaborate effectively at all levels to drive delivery in a dynamic, fast paced environment.
• Quality metrics, dashboards, analysis and improvement programs
• 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

 

Minimum qualifications:

 

• Bachelors Degree in a scientific