Global Clinical Quality (GCQ) Associate Director
Vertex Pharmaceuticals
9 hours ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
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 trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols, and Vertex policies/procedures and quality standards in the Quality Management System. Activities include development/execution of study-level audit plans; identifying and communicating compliance risks and overseeing mitigation action plans; monitoring and trending quality risks, issues, and compliance metrics; investigation and CAPA management; and proactive inspection readiness.
Key Duties and Responsibilities:
- Serve as a key technical resource for GCP clinical execution; assure quality risk management/mitigation and compliance to protect subjects’ safety, rights, well-being, and data integrity
- Liaise with clinical functions and external parties (CROs, vendors, investigator sites) to promote quality and consistency
- Partner with QA and business leadership to ensure quality and compliance of internal operations and applicable vendors
- Participate on the Risk Governance Team to assess GCP compliance risks (internal/external) and implement mitigation measures
- Provide guidance/interpretation on regulations, standards, and quality systems to GCP functional areas
- Develop and measure quality metrics to drive proactive/predictive quality improvements
- Develop and lead inspection readiness activities for assigned programs
- Provide specialized consultative guidance on GXP business initiatives (systems, processes, procedures, regulations, tools) for regulated clinical trial conduct
- Participate in evaluation/selection of GCP service providers
- May provide functional area leadership and management; conduct performance management (goals, monitoring, reviews)
- Participate in learning and development (identify training needs/support 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/analyze KPI data and trends; analyze risk and propose remedial/corrective/preventive actions
- Develop and maintain relationships with GCP vendors to conform to quality agreements; participate in vendor joint operating committees as needed
- Provide QA review of protocols to identify operational risks and support risk mitigation strategy development
- Develop risk-based audit plans; ensure audits are conducted per plan; review audit reports; evaluate responses and CAPA plans; assess impact to subject safety, data integrity, and business operations; escalate significant compliance risks
- Manage (and may lead) domestic and international audits for clinical investigators to ensure ICH GCP and applicable regulatory/company compliance
Knowledge and Skills:
- In-depth knowledge of ICH GCP E6 R2 and applicable global regulations/guidance (e.g., FDA, EMA, MHRA)
- Significant experience across all phases of clinical trial development (drugs, biologics, devices, and combinations)
- Knowledge of industry trends/best practices for progressive quality risk management
- Technical depth in event management: investigation, root cause analysis, CAPA development, and effectiveness checks
- Ability to translate customer needs into quality management solutions
- Clear professional communication (verbal and written) to internal/external customers
- Ability to work independently with minimal guidance; organize/prioritize to ensure timely, accurate, high-quality execution
- Scientific knowledge to manage quality oversight for clinical trials (medical terminology, standards of care, disease states)
- Proficiency managing complex projects and meeting goals/deadlines
- Background in risk management principles/tools
- Proficient with Microsoft Office (Word, Excel, PowerPoint, Visio)
- Ability/willingness to travel up to 15%
Education and Experience:
- B.S. in a scientific or allied health field
- Typically at least 8 years of experience in GCP/GxP Quality Assurance (or equivalent education/experience)
Benefits (as stated):
- Annual bonus and annual equity awards
- Eligible for overtime pay in accordance with federal and state requirements (where applicable)
- Total Rewards include medical, dental, vision; paid time off (including week-long company shutdown in Summer and Winter); educational assistance (student loan repayment); commuting subsidy; matching charitable donations; 401(k)
Work Location Flex:
- Hybrid-eligible (remote up to two days/week) or On-site (five days/week on-site with ad hoc flexibility)
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 trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols, and Vertex policies/procedures and quality standards in the Quality Management System. Activities include development/execution of study-level audit plans; identifying and communicating compliance risks and overseeing mitigation action plans; monitoring and trending quality risks, issues, and compliance metrics; investigation and CAPA management; and proactive inspection readiness.
Key Duties and Responsibilities:
- Serve as a key technical resource for GCP clinical execution; assure quality risk management/mitigation and compliance to protect subjects’ safety, rights, well-being, and data integrity
- Liaise with clinical functions and external parties (CROs, vendors, investigator sites) to promote quality and consistency
- Partner with QA and business leadership to ensure quality and compliance of internal operations and applicable vendors
- Participate on the Risk Governance Team to assess GCP compliance risks (internal/external) and implement mitigation measures
- Provide guidance/interpretation on regulations, standards, and quality systems to GCP functional areas
- Develop and measure quality metrics to drive proactive/predictive quality improvements
- Develop and lead inspection readiness activities for assigned programs
- Provide specialized consultative guidance on GXP business initiatives (systems, processes, procedures, regulations, tools) for regulated clinical trial conduct
- Participate in evaluation/selection of GCP service providers
- May provide functional area leadership and management; conduct performance management (goals, monitoring, reviews)
- Participate in learning and development (identify training needs/support 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/analyze KPI data and trends; analyze risk and propose remedial/corrective/preventive actions
- Develop and maintain relationships with GCP vendors to conform to quality agreements; participate in vendor joint operating committees as needed
- Provide QA review of protocols to identify operational risks and support risk mitigation strategy development
- Develop risk-based audit plans; ensure audits are conducted per plan; review audit reports; evaluate responses and CAPA plans; assess impact to subject safety, data integrity, and business operations; escalate significant compliance risks
- Manage (and may lead) domestic and international audits for clinical investigators to ensure ICH GCP and applicable regulatory/company compliance
Knowledge and Skills:
- In-depth knowledge of ICH GCP E6 R2 and applicable global regulations/guidance (e.g., FDA, EMA, MHRA)
- Significant experience across all phases of clinical trial development (drugs, biologics, devices, and combinations)
- Knowledge of industry trends/best practices for progressive quality risk management
- Technical depth in event management: investigation, root cause analysis, CAPA development, and effectiveness checks
- Ability to translate customer needs into quality management solutions
- Clear professional communication (verbal and written) to internal/external customers
- Ability to work independently with minimal guidance; organize/prioritize to ensure timely, accurate, high-quality execution
- Scientific knowledge to manage quality oversight for clinical trials (medical terminology, standards of care, disease states)
- Proficiency managing complex projects and meeting goals/deadlines
- Background in risk management principles/tools
- Proficient with Microsoft Office (Word, Excel, PowerPoint, Visio)
- Ability/willingness to travel up to 15%
Education and Experience:
- B.S. in a scientific or allied health field
- Typically at least 8 years of experience in GCP/GxP Quality Assurance (or equivalent education/experience)
Benefits (as stated):
- Annual bonus and annual equity awards
- Eligible for overtime pay in accordance with federal and state requirements (where applicable)
- Total Rewards include medical, dental, vision; paid time off (including week-long company shutdown in Summer and Winter); educational assistance (student loan repayment); commuting subsidy; matching charitable donations; 401(k)
Work Location Flex:
- Hybrid-eligible (remote up to two days/week) or On-site (five days/week on-site with ad hoc flexibility)