Associate Director, GMP Operational Quality (Biologics and Device Quality) at Vertex Pharmaceuticals

Job DescriptionGeneral Summary:The Associate Director GMP Operational Quality will provide leadership and quality oversight for contract testing laboratories (CTLs) supporting Vertexs biologics and combination product portfolio across development PPQ launch and commercial lifecycle management. This role ensures that analytical testing method execution and data generated by external laboratories meet Vertex global regulatory and data integrity standards.Key Duties and Responsibilities:Serve as the primary QA lead for CTLs supporting release stability characterization and device-related testing for Vertexs biologics and combination products.Provide quality oversight for analytical method qualification/validation method transfer and lifecycle management activities executed by CTLs.Review and approve analytical protocols reports testing plans stability protocols and Quality Agreements.Ensure investigations (OOS/OOT/OOE) deviations CAPAs and change controls originating from CTLs meet Vertex standards and are compliant with global GMP expectations.Lead quality reviews performance assessments and risk management activities for the external testing network.Conduct or oversee QA review of analytical data packages COAs stability trending device analytical outputs and raw data from CTLs.Ensure compliance with ALCOA principles and global data integrity guidelines.Partner with Analytical Development and QC to evaluate method performance assay robustness and analytical control strategies.Provide QA input into specification setting control strategy development and analytical comparability assessments.Support analytical method development activities by ensuring appropriate QA oversight during method lifecycle progression.Provide QA support during method transfers PPQ readiness and commercial launch activities.Ensure CTLs are prepared to support global commercial supply including alignment with international regulatory expectations.Contribute QA expertise to device-related analytical programs including testing strategies for drug-device combination products.Support CTL audits and regulatory inspections involving analytical methods testing or device-related analytics.Maintain and update Quality Agreements ensuring alignment with evolving program and regulatory needs.Drive continuous improvement in Vertexs external testing oversight model including procedures metrics and governance.Serve as a QA subject matter expert for analytical and device-related testing across biologics and combination product programs.Collaborate with CMC Analytical Development QC MS&T Device Engineering QA Device and Regulatory Affairs to ensure robust analytical control strategies.Represent QA in analytical lifecycle teams technical forums and program governance meetings.Knowledge and Skills:Demonstrated experience overseeing contract testing laboratories supporting biologics sterile products or combination products.Strong understanding of analytical method development validation transfer and lifecycle management.Knowledge of biologics analytical control strategies immunoassays cell-based assays potency assays and device analytical requirements.Familiarity with combination product regulations (21 CFR Part 4) global GMPs and data integrity expectations.Experience supporting clinical development through commercial supply including PPQ launch readiness and post-approval changes.Excellent leadership communication and influencing skills in a highly matrixed environment.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 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