GCP Operational Quality Associate Director

Vertex Pharmaceuticals Inc (US); Boston (MA); Hybrid; USD 157,000 - 235,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Paid time off

Tuition assistance

Commuting subsidy

401(k)

Job summary

Vertex Pharmaceuticals Incorporated seeks an Associate Director, Biomarkers Operational Quality to provide leadership and oversight across GxP activities from research through development, including potential commercialization of clinical biomarkers. You will drive quality outcomes, collaborate with Biomarker Operations and Quality partners, and use meaningful metrics to monitor process health and risk.

The role integrates with R&D, regulatory reviews, and vendor quality management to ensure

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.

Responsibilities

• Partner with quality/compliance oversight of preclinical and clinical activities across modalities in collaboration with Clinical Biomarkers and Quality.
• Contributes to regulatory document reviews, including BBs, INDs, IDEs, and TMFs, identifying potential risks or gaps.
• Provides input in development of GCLP and GCP Biomarker audit scope/focus for vendor audits.
• Supports processes, procedures, regulations and tools to support non-clinical activities.
• Designs quality metrics and participates in governance meetings to improve regulatory compliance across programs.

Skills

CLIA regulations

Data integrity

GxP awareness

Quality metrics

Communication skills

Education

Bachelor’s Degree in science or allied health

Job description

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:

• 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

Pay Range:

Pay Range: $156,600 - $234,800 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 Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

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 [e-mail] Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. 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 IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters 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 16 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 LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.