General Summary:The Senior Director, Clinical Quality & Development Operations (CQDO) Good Clinical Practice (GCP) Compliance provides enterprise‑level leadership and strategic oversight to ensure Global Clinical Operations (GCO) maintains a sustained state of GCP compliance. The role is accountable for embedding a proactive GCP compliance capability, provides strategic oversight and governance for GCO owned Risk Management Plans (RMPs), clinical site holds and closures, Quality Risks, and Serious Breach assessments, ensuring proactive risk identification, regulatory compliance, and effective quality risk mitigation across the clinical development portfolio. Through leadership of a high‑performing CQDO team, this role ensures quality and compliance are consistently aligned with GCO objectives and broader corporate strategy.Key Duties And ResponsibilitiesLead Quality Event Management activities related to the investigation, root cause analysis and development of corrective action/ preventive action plans for GCO assigned events, including unplanned deviations, corrective/ preventive actions and effectiveness checks ensuring timelines for closure are metParticipate in GCP Event Action Committees (EAC’s) as neededLeads the development and oversight of GCO owned Risk Management Plans (RMPs), site hold and closure activities, Quality Risks, and Serious Breach assessments, driving quality governance, risk-based decision making, and inspection readiness throughout the clinical trial lifecycle.Ensure consistency develop method for continuous process improvementAnalyze the risks for readiness and manage the implementation of readiness program, and develop lessons learned after each inspection.Develop strategy with Global Clinical Operations in the development of CAPA plans and investigations in response to audits and inspections. Ensure inspections findings are remediated and processes are implemented within GCO.Oversee the development and implementation of quality frameworks, operational standards, and risk mitigation strategies across clinical programs, with a focus on harmonizing global processes and ensuring compliance with regulatory requirementsAdvanced leadership and execution of business strategyAdvanced ability to leverage knowledge of the potential future stakeholder landscape and to support the pipeline and identify those who will be the most influential, internal and external, to VertexChampions well-founded perspectives with authority and strategic insight, inspiring stakeholder confidence and securing buy-in-even when navigating complex, unfamiliar, or contentious subject matter.Demonstrates exceptional leadership by fostering open dialogue, addressing divergent opinions constructively, and driving consensus to advance organizational objectivesLeads the conception and implementation of transformative solutions that proactively address dynamic business challenges, ensuring alignment with industry standards and regulatory requirementsDemonstrates a forward-thinking approach by fostering innovation, driving cross-functional collaboration, and embedding quality and compliance into every stage of solution developmentIdentifies and resolves technical and operational problems, understands broader impact on the departmentProvides strategic input to solve complex problems while exercising judgment using multiple sources of information.As a people manager with have financial accountabilities and human resource responsibilities for assigned staffKnowledge And SkillsExpert ability to leverage knowledge of organizational goals and interdependencies with other functional areas to drive successExpert understanding of GCP, CFR and ICH guidelines and Health Authority regulationsLead cross-functional projects of high complexity with cross-functional team members and represent Clinical Quality & Development Operations on other large-scale projects/initiativesDevelops strategy for their domain in alignment with Clinical Quality & Development Operations (CQDO), Global Clinical Operations, and Global Medicines Development & Medical Affairs program strategy and goalsLeads major projects in support of GCO infrastructure and makes department-wide decisionsExtensive Global Clinical Operations/Clinical Development experience in multiple therapeutic areasExceptional strategic vision and leadership capabilitiesExpert knowledge in system/technical tools and processesDemonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment.Results orientedExcellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary teamExcellent verbal and written communication and presentation skillsExcellent analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision makingExpertise rations and resource/budget planning across global geographiesKnowledge of emerging technologies and trends.Ability to drive innovation and excellence.Proven strong business acumenExcellent project management, critical thinking and problem-solving skillsDemonstrated adaptability, flexibility, independence and resourcefulness to thrive in a mid-sized company environmentEducation And ExperienceBachelor of Science degree in a life sciences disciplineTypically requires 15 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry5 years of supervisor/management experiencePay Range$222,200 - $333,200Disclosure StatementThe 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 ancial, 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 Eligibility Statuscan choose to be designated as:Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or selectHybrid: work remotely up to two days per week; or selectOn-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.Company InformationVertex 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
about 2 months ago