Operational Area Quality Associate Director at Vertex Pharmaceuticals

Job DescriptionGeneral Summary:The Associate Director GMP Operational Quality is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for primary QA oversight of commercial drug substance manufacturing performed at Vertexs external vendors as well as secondary quality support of commercial drug product manufacturing vendors. This position ensures robust sterile manufacturing controls commercial supply continuity support for global jurisdictional expansion and highlevel combination product quality alignment. The incumbent will mentor team members to provide individual development in addition to efficient and valuable service to project teams.Key Duties and Responsibilities:Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutionsOversee CMO/Vendor performance establishment of Quality Agreements and adherence of Quality Agreement termsEnable team to achieve team goals/objectives and enable their individual career developmentDevelop and maintain compliant quality processes to support GMP activitiesOversee the QA support of Change Controls GMP investigations and associated CAPAs.Performs review and approval of master and executed batch records to support drug substance (DS) drug product (DP) device (Autoinjector) and finished goods (FG) disposition activitiesTrack performance metrics and report to Sr Management; develops tactics to improve performance outcomesParticipate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections.Support review of regulatory submissions as applicableLead continuous improvements of department processes realizing efficiency gains and ensuring team continues to meet expanding business needs with lean resources.Lead and follow up on any QLT action items assigned.Identify and communicate risks and assist with risk mitigation plans as necessarySupports internal audit or external audit programs; assists in preparation of audit responsesProvide comprehensive knowledge support for partner and regulatory agency auditsAssist management team in budgeting and schedulingResponsible for the following activities related to people management responsibilities:Talent Acquisition/ Recruiting/Interviewing/ Selection/OnboardingAccountable to provide oversight of day to day team operationsKnowledge and Skills:In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturingDemonstrated success in building high-performing teams and skilled at managing team and individual developmentStrong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality accuracy and timelinessSubstantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings assist with project planning and facilitate attainment of project objectivesAbility to independently lead cross-functional teams and represent the interests strategies and objectives of Quality unitStrong skills in mentoring staff and transferring technical knowledge to enable their capabilities and developmentAbility to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders customers or vendors to adopt of a new point of view and/or to take actionDemonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutionsSubstantial experience successfully leading event investigations Root Cause Analysis (RCA) and CAPAExtensive exposure with multiple regulatory agencies across applicable GxPs during inspectionsSupstantial experience with electronic document management systems (e.g. Veeva)Education and Experience:Bachelors degree in a scientific or allied health field (or equivalent degree)Typically requires 8 years of work experience and 2 years of management experience or the equivalent combination of education and experience#LI-hybridPay Range:$154100 - $231200Disclosure 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 EligibleFlex 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 select2. On-Site: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.#LI-HybridCompany 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 persons 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 Required Experience:Director Key Skills Distribution,IT,Access Control System,B2C,Courier Delivery,Broadcast Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 154100 - 231200