Associate Director, Clinical Study Quality Lead (Hybrid)

Job Description General Summary: The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality assurance oversight of clinical trial operations and applicable vendors, across a range of study phases within assigned disease area(s).

The SQL will ensure clinical trials are conducted in accordance with GCP requirements, applicable protocols, Vertex policies and procedures and quality standards as set forth in the Quality Management System.

Overall, the SQL is responsible for the development and execution of audit/quality plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, real-time study inspection readiness oversight, and collaboratively identifying and driving inspection preparedness strategies and activities.

This position may evolve to include line management responsibilities. Key Duties and

Responsibilities: Serves as key technical resource and GCP subject matter expert, to clinical study execution functions.

Provides strategic, risk-based GCP quality compliance oversight of studies within assigned disease areas to drive compliance with regulatory requirements to ensure the protection of participants' safety, rights, and well-being as well as the integrity and credibility of study data generated.

Provides consultation, interpretation and information on regulations, standards, and quality systems to clinical study execution functions Partners with clinical and other study functional teams to engage proactive quality management approaches in support of risk mitigation and quality outcomes Proactively supports and/or identifies study/program quality risks ensuring that risks are communicated and mitigated in a timely manner.

Participates in risk management forums with responsibility for assessing GCP compliance risk areas; Develops and implements quality risk management plans and measures.

Partners with operational teams to develop risk-based quality and/or audit plans for assigned programs, ensuring audits are conducted in accordance with the plan.

Reviews audit reports and may evaluate responses and CAPA plans. Develops and executes inspection preparedness strategy for assigned studies/programs in collaboration with Functional Area and Quality partners.

Participates in inspection activities from preparation to response execution. Conducts directed or for cause audits and site inspection preparation visits as needed Oversees investigation and approves quality event investigations and CAPA(s) May provide regular updates on study and program status to the R&D Quality Leadership Team and senior stakeholders in GCP Quality.

May provide direction and expertise at management review meetings on GCP-related activities/risks/issues. Represents Quality in study management and quality/compliance forums, teams, governance, etc. as well as on interdepartmental process improvement and business initiatives involving GCP systems, processes, procedures, regulations, and tools.

May provide subject matter expertise and participate in the development and review of procedural documents related to the Quality Management System (e.g., CAPA, Quality Issue Management, regulatory inspections, quality risk management).

Maintains an in-depth understanding of business principles, current industry trends, standards, and methodologies and regulatory environment as relates to clinical development, quality management and Good Clinical Practice.

Participates in the evaluation and selection of GCP service providers Monitors key quality indicators and departmental metrics for and identifies opportunities to optimize processes and procedures (SOPs, Work Instructions).

May act on behalf of overseeing Clinical Quality Program Lead Mentor and train junior SQLs, as needed Role may progress to include people management responsibilities including hiring, oversight of day-to-day execution, employee goal setting, performance management, and career development activities Education and Experience: Bachelor's degree in a scientific or allied health field (or equivalent degree) and 8+ years of relevant work experience, or relevant comparable background Required Experience: In depth knowledge and awareness of ICH-GCP guidelines and applicable global regulations and guidance for clinical development (e.g., FDA, EMA, MHRA, etc.) Experience across phases of clinical trial development involving drugs, and biologics In depth understanding of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks Ability to understand and translate business partner needs for innovation and creative, risk-based approaches to quality management Communicates professionally, clearly, and concisely both verbally and in writing to internal and external customers Excellent organizational skills, problem solving and conflict resolution skills Must be able to organize and prioritize work effectively to meet timelines with quality deliverables Must possess the necessary scientific education and knowledge to manage quality oversight for clinical trials, understand medical terminology, standards of care and disease states to assure the ethical treatment of participants Must be able to work independently and in a collaborative team setting Proficient in using Microsoft Office applications (MS Word, MS Excel, MS PowerPoint, Smartsheet, Visio) Strong experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics Other Requirements Prior experience with medical device manufacture and transition to clinical studies or Cell and Gene Therapy is advantageous.

Professional clinical trial certification (e.g., CCRP, RQAP-GCP, etc.) is preferred Travel up to 10% is required to Vertex sites, vendors, investigator sites, etc. #LI-Hybrid Pay Range: $160,600 - $240,800 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. #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 ApplicationAssistance@vrtx.com 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.

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.