GCP Operational Quality Associate Director

Vertex Inc.•Boston, MA

1d•$156,600 - $234,800•Hybrid

About The Position

The Biomarker Operational Quality Associate Director provides Biomarker quality leadership and oversight across GxP areas related to research and development, implementation into clinical trials, and potential commercialization of clinical biomarkers into IVDs. The role collaborates with business partners and GCP Operational Quality to support operational management oversight and drive quality outcomes and operational excellence. It ensures quality oversight activities maximize value, impact, and delivery while supporting compliance, quality excellence, and readiness for future needs. The Associate Director works with Biomarker Operations to develop meaningful quality indicators and metrics for evaluating process and quality-system health and identifying risks. The role reports directly to the Director, GCP Biomarker Operational Quality and works closely with other Quality members to support appropriate GxP compliance and consistent, fit-for-purpose quality oversight across programs and products. It also supports non-regulated Research staff through training, quality reviews of non-GxP materials intended for regulatory submissions, communication and escalation of assessment outcomes, and assistance with presentations, training, and complex projects.

Requirements

Bachelor’s degree in a scientific or allied health field.
Typically 10 years of experience or an equivalent combination of education and experience.
Strong knowledge of data integrity principles and ALCOA.
Broad knowledge of CLIA regulations (42 CFR Part 493), international equivalents, and applicable guidance such as ISO 15189:2022 and CLSI.
Knowledge of in-vivo and/or in-vitro experimental design, planning, conduct, and reporting.
Demonstrated experience interpreting and applying relevant GxP requirements, such as GLP and Medical Device requirements, across products to drive phase-appropriate quality.
Ability to collaborate effectively at all levels to drive delivery in a dynamic, fast-paced environment.
Knowledge of quality metrics, dashboards, analysis, and improvement programs.
Excellent communication skills and a track record of influencing, building, and promoting a culture of quality and excellence.
Strong problem-solving and critical-thinking skills 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 and collaboratively.
Detail-oriented and goal-oriented, with the ability to exercise good judgment.

Responsibilities

Provide appropriate quality and compliance oversight of preclinical and clinical biomarker activities, including fit-for-purpose validations and associated processes, in collaboration with Clinical Biomarkers and internal stakeholders.
Contribute to reviews of regulatory documents, including BBs, INDs, IDEs, and TMFs, and identify potential risks or gaps.
Provide input into requested and for-cause GCLP and GCP Biomarker vendor audit scope and focus.
Support business initiatives involving processes, procedures, regulations, and tools intended to support non-clinical activities.
Participate in cross-functional initiatives to improve compliance with regulatory requirements, standards, and internal Vertex policies.
Identify potential compliance issues that may affect business goals and develop and implement practical improvements and resolutions.
Contribute to proactive reporting of significant quality issues related to Vertex Preclinical product development and represent an aligned Quality perspective.
Contribute to inspection readiness activities for product-development processes, including quality assessments of GLP/GCP Biomarker studies when requested.
Advise on audit strategy for GLP/GCP Biomarker vendors, processes, and systems.
Engage with R&D vendor quality to provide input on vendor performance and risks.
Contribute to governance meetings, including agenda topics and meaningful metrics.
Collaborate with Clinical and Preclinical stakeholders and Quality partners to design appropriate quality metrics for Biomarker activities.
Communicate summary trending and insights about quality delivery in preclinical and clinical studies to relevant stakeholders and forums, including Integrated Risk Teams.
Participate in due diligence and integration activities as appropriate.
Train Research staff on applicable Vertex policies, guidance, and procedures, particularly for functions generating non-GxP research intended for regulatory filings.
Conduct Research QA reviews of non-GxP protocols and reports intended for regulatory submissions to assess clarity, consistency, and alignment with Vertex and regulator expectations.
Communicate and, when necessary, escalate quality-assessment outcomes, trends, and action items to meet Vertex Research needs.
Assist with developing presentations and training.
Assist with oversight and management of complex projects to ensure milestones are met.
Collaborate with business stakeholders and Quality partners to develop meaningful quality metrics.

Benefits

Annual bonus eligibility.
Annual equity awards.
Medical insurance.
Dental insurance.
Vision insurance.
Generous paid time off, including a week-long company shutdown in the summer and winter.
Educational assistance programs, including student loan repayment.
Commuting subsidy.
Matching charitable donations.
401(k).
Other benefits and resources supporting employees’ career, financial, family, and wellbeing needs.