Director, Analytical Product Quality

Job Description General/Position Summary The Director of Analytical Product Quality is responsible for the quality oversight of analytical development activities throughout the product development lifecycle for Cell & Genetic therapy programs. This role includes Quality Assurance support to cross-functional partners for the method validation of applicable analytical methods and support on analytical transfer activities to contract manufacturers, test labs and internal laboratories as applicable. The role will closely partner with operational stakeholders to participate in Cell & Genetic therapies projects to meet business, regulatory and operational requirements. Key Duties & Responsibilities Proactively maintain Quality Assurance oversight of the method development, and qualification activities for the applicable methods/program. Responsible for the QA oversight of the stability program to assure compliance with internal Vertex procedures and EU/US regulatory standards. Ensure compliance with cGMPs. Lead quality review for analytical development activities, analytical method qualification/validation protocols and reports including associated approval. Supports development of the program analytical strategy with cross-functional stakeholders. Drive investigations for out of specifications, root cause analysis and effective corrective and preventive actions implementation. Primary quality oversight of the reference standard program for the applicable methods. Lead/participate in the development of Vertex global Quality system standards and SOPs. Review and approve relevant documentation including deviation investigations and change control. Support review of relevant sections of regulatory submissions including IND's as assigned; Assist in responses to regulatory questions where applicable. Responsible for identifying compliance risks and gaps, and associated execution for the implementation of mitigating controls. Support contract test labs management process including the creation and review of Quality Agreements. Lead/participate in Cell & Genetic Program Quality & technical projects and drive continuous improvement activities as assigned by Management. Ensure activities and deliverables are in compliance with FDA, EMA, SOPs and industry best practices. Required Education Level Bachelor's degree, Master's degree, or PhD in an engineering/Lifesciences field or relevant comparable background Required Experience Typically requires 10+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment. Required Knowledge/Skills In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics, broad knowledge of ICG Guidelines, EU/FDA regulations. Experience in method development for cellular programs, clinical product development and analytical method development Broad understanding of regulatory environment including quality systems, compliance and strategy for Cell & gene technology Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma. Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence. Ability to apply risk management principles to decision making and operational priorities. Critical Thinker and Problem Solver Strong influencing skills and an innate ability to collaborate and build relationships Other Requirements Up to 5% travel Pay Range $180,800 - $271,200 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 On-Site Designated Flex Eligibility Status In this On-Site designated role, you will 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 Information Vertex is a global biotechnology company that invests in scientific innovation. Equal Opportunity Statement 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 View email address on click.appcast.io. #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated