Vertex Pharmaceuticals Incorporated
Director, RDQA, GCP Operational Quality, CGT
Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, us, 02298
Director, RDQA, GCP Operational Quality, CGT
The Director of GCP Operational Quality performs advanced GCP quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies, procedures, and quality standards as set forth in the Quality Management System. These activities include the operational quality oversight of the clinical development programs specifically within our Cell and Gene Therapy (CGT) Disease Areas of the clinical portfolio.The Director of GCP Operational Quality will develop and maintain collaborative relationships with all stakeholders and business partners and be the key point of contact for all Quality related clinical activities in CGT Programs. These may include Program and Study level quality risk assessment and mitigation, inspection readiness activities, quality event identification and mitigation with participation in escalation activities as required.Key capabilities for this position are the ability to lead and influence Program Teams to ensure a high level of capabilities within the CGT space, overall compliance, distill complex risks and issues to meaningful and easily understood updates to senior leadership, strong collaborator with good judgement and business acumen, willing to be a mentor / coach to more junior Quality Associates, partner across Vertex Quality to understand critical touch points across the Program, and have meaningful input to creating metrics and KPIs for Program updates.This individual will support RDQA's initiative to elevate overall capabilities, understanding and expertise within the CGT space by supporting the development of a CGT Center of Excellence that promotes education, awareness and fit-for-purpose tools, templates, libraries and training materials to grow and develop the bench to become experts and specialists in this space in support of optimal onboarding, training, learning and development.This position reports directly to the Head of RDQA.Key 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 key stakeholders and business partners to promote high level of quality and consistency across and within programs in CGT.Partner with QA and business leadership for coordination and alignment in ensuring overall quality and compliance of internal operations and applicable vendors.Lead Quality Program Updates and participate in Operational Quality Leadership / Governance Teams responsible for assessing GCP compliance risk areas (internal and external) and develop and implement risk mitigation measures; Lead Stage Gate Reviews for advancing trials through clinical phases for assigned programs. Responsible for identifying, evaluating, and mitigating risk collaboratively with business partners to understand and communicate quality risks as applicable to Clinical Programs as well as propose appropriate remedial, corrective and/or preventive actions.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 ensure consistent quality standards relating to GCP activities to drive proactive and predictive quality improvements.Ensure inspection readiness 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, which includes Performance Management (goals, monitoring, reviews), Employee Learning and Development (Identification of training needs and support of aspirational goals, Talent Acquisition/Recruiting/Interviewing/selection, Onboarding/Transition/Succession Planning, and Oversight of day-to-day execution).May serve as GCP Quality Management System representative.Participate in collaborative review of impacted controlled documentation related to Vertex Standards, SOPs, and Work Instructions.Review and analyze key Performance Indicator data and trends.May participate on process improvement initiatives.Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborates with Program and Study teams in development of risk mitigation strategies.Collaborates with Audit and Inspection Management teams to develop 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.Minimum Qualifications:Bachelor's degree in a scientific or allied health field (or equivalent degree).At least 10 years of GCP Operational QA experience in addition to 5 years of management experience or the equivalent combination of education and experience.Preference to candidates with GLP and/or GVP experience in addition to the required GCP background.Preference for candidates with a Legal, Privacy or Regulatory background, in addition to Quality, including prior experience working for a Health Authority.Flex Designation:Hybrid-Eligible or On-Site EligibleCompany 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.Helping diverse candidates find great careers is our goal. The information you provide here is secure and confidential.
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The Director of GCP Operational Quality performs advanced GCP quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies, procedures, and quality standards as set forth in the Quality Management System. These activities include the operational quality oversight of the clinical development programs specifically within our Cell and Gene Therapy (CGT) Disease Areas of the clinical portfolio.The Director of GCP Operational Quality will develop and maintain collaborative relationships with all stakeholders and business partners and be the key point of contact for all Quality related clinical activities in CGT Programs. These may include Program and Study level quality risk assessment and mitigation, inspection readiness activities, quality event identification and mitigation with participation in escalation activities as required.Key capabilities for this position are the ability to lead and influence Program Teams to ensure a high level of capabilities within the CGT space, overall compliance, distill complex risks and issues to meaningful and easily understood updates to senior leadership, strong collaborator with good judgement and business acumen, willing to be a mentor / coach to more junior Quality Associates, partner across Vertex Quality to understand critical touch points across the Program, and have meaningful input to creating metrics and KPIs for Program updates.This individual will support RDQA's initiative to elevate overall capabilities, understanding and expertise within the CGT space by supporting the development of a CGT Center of Excellence that promotes education, awareness and fit-for-purpose tools, templates, libraries and training materials to grow and develop the bench to become experts and specialists in this space in support of optimal onboarding, training, learning and development.This position reports directly to the Head of RDQA.Key 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 key stakeholders and business partners to promote high level of quality and consistency across and within programs in CGT.Partner with QA and business leadership for coordination and alignment in ensuring overall quality and compliance of internal operations and applicable vendors.Lead Quality Program Updates and participate in Operational Quality Leadership / Governance Teams responsible for assessing GCP compliance risk areas (internal and external) and develop and implement risk mitigation measures; Lead Stage Gate Reviews for advancing trials through clinical phases for assigned programs. Responsible for identifying, evaluating, and mitigating risk collaboratively with business partners to understand and communicate quality risks as applicable to Clinical Programs as well as propose appropriate remedial, corrective and/or preventive actions.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 ensure consistent quality standards relating to GCP activities to drive proactive and predictive quality improvements.Ensure inspection readiness 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, which includes Performance Management (goals, monitoring, reviews), Employee Learning and Development (Identification of training needs and support of aspirational goals, Talent Acquisition/Recruiting/Interviewing/selection, Onboarding/Transition/Succession Planning, and Oversight of day-to-day execution).May serve as GCP Quality Management System representative.Participate in collaborative review of impacted controlled documentation related to Vertex Standards, SOPs, and Work Instructions.Review and analyze key Performance Indicator data and trends.May participate on process improvement initiatives.Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborates with Program and Study teams in development of risk mitigation strategies.Collaborates with Audit and Inspection Management teams to develop 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.Minimum Qualifications:Bachelor's degree in a scientific or allied health field (or equivalent degree).At least 10 years of GCP Operational QA experience in addition to 5 years of management experience or the equivalent combination of education and experience.Preference to candidates with GLP and/or GVP experience in addition to the required GCP background.Preference for candidates with a Legal, Privacy or Regulatory background, in addition to Quality, including prior experience working for a Health Authority.Flex Designation:Hybrid-Eligible or On-Site EligibleCompany 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.Helping diverse candidates find great careers is our goal. The information you provide here is secure and confidential.
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