Clinical Study Quality Lead, Associate Director

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:

• 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
• 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.
• Partner with QA and business leadership for coordination and alignment in ensuring overall quality and compliance of internal operations and applicable vendors.
• Participate on Integrated Risk Governance Team responsible for assessing GCP compliance risk areas (internal and external) and develop and implement risk mitigation measures; Lead Stage Gate Reviews for advancing trials thorough clinical phases for assigned programs.
• Provide guidance, interpretation and information on regulations, standards and quality systems to GCP functional areas responsible for clinical trial execution.
• Develop and measure quality metrics to drive consistent quality standards relating to GCP activities to drive proactive and predictive quality improvements.
• Develop and lead inspection readiness activities for assigned programs.
• 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 GCP service providers.
• May provide functional area leadership and management
• Performance Management (goals, monitoring, reviews)
• Employee Learning and Development (Identification of training needs and support of aspirational goals via IDP)
• Talent Acquisition/ Recruiting/Interviewing/ selection
• Onboarding/ Transition/Succession Planning
• Oversight of day to day execution
• May serve as GCP Quality Management System representative
• Participate in collaborative review of impacted SOP/WI
• Review and analyzes key Performance Indicator data and trends
• Analyze risk and proposes remedial, corrective and /or preventive actions
• May participate on process improvement initiatives
• Develop and maintain relationships with GCP Vendors to conform to quality agreements, and participates on applicable Vendor Joint Operating Committees, as needed.
• Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborates with study team in development of risk mitigation strategies.
• 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.
• 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

Knowledge and Skills:

• 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

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

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:

Disclosure Statement:

Flex Designation:

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