Associate Director - GCP Operational Quality, Biomarkers

Job Description

General position summary: 

Biomarker Operational Quality Associate director 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 Associate Director 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.

Key Responsibilities:

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

Biomarkers

·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.

Non-regulated Research

• 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.

Knowledge and Skills:

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

• Knowledge of in-vivo and/or in-vitro experimental design, planning, conduct and reporting"

•  Contribute to cross-functional team discussions and effectively represent the viewpoint of the Research QA group.

· Demonstrated experience interpreting and applying relevant GxP (e.g., GLP, Medical Device) 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.

·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

• Ability to work in a fast-paced environment and manage competing priorities.
• Very good oral and written communication skills.
• Ability to work independently, as well as with others.
• Detail and goal oriented and able to exercise good judgment.

  Minimum qualifications:

·  Bachelor’s Degree in a scientific or allied health field

·  Typically requires 10 years’ experience or the equivalent combination of education and experience

·  Strong knowledge of data integrity principles and ALCOA

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We 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.

Pay Range:

$156,600 - $234,800

Disclosure Statement:

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid
 

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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]