Associate Director, GCP Operational Quality Biomarkers (Hybrid)

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:

Bachelors 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:

$156600 - $234800

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other job-related factors permitted by law.

At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.

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 Vertexs 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 persons 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

Required Experience:

Director