GCP Biomarker Quality Associate Director

Boston, MA, United States

GCP Biomarker Quality Associate Director page is loaded GCP Biomarker Quality Associate Director Apply locations Boston, MA time type Full time posted on Posted 5 Days Ago job requisition id REQ-21957 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

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].

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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com  or follow us on Facebook , Twitter/X ,  LinkedIn ,  YouTube  and  Instagram .

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.

Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

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