Job Description
General Summary:
The Associate Director of GCP Operational QA performs advanced GCP Quality Assurance oversight and management activities of clinical trial operations and applicable vendors, to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and Vertex policies and procedures and quality standards as set forth in the Quality Management System. These activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, monitoring and trending of quality risks, issues and compliance metrics, investigation and CAPA management and proactive inspection readiness activities.
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 Risk Governance Team responsible for assessing GCP compliance risk areas (internal and external) and develop and implement risk mitigation measures.
- 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
- Conduct Performance Management (goals, monitoring, reviews)
- Participate in 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 analyse Key Performance Indicator data and trends
- Analyse 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 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 may lead) 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
- Current knowledge of industry trends and best practices - for progressive quality risk management in a regulated environment
- Significant technical depth in Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks.
- Ability to understand and translate customer needs and develop dynamic or novel solutions to quality management
- Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
- 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.
- Proficient in using Microsoft Office applications (MS Word, MS Excel, MS PowerPoint, Visio).
- Willing and able to travel up to 15% of working time
Education and Experience:
- B.S. in a scientific or allied health field
- Typically requires at least 8 years of experience in GCP/GxP Quality Assurance or the required combination of education and experience
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