Senior Manager, QA Technical GMP Drug Substance (Hybrid)

Job DescriptionGeneral Summary:The Senior Manager Quality Technical GMP Drug Substance will be a hands-on QA Technical Subject Matter Expert in collaboration with external CDMOs, Contract Laboratories, and internal cross-functional teams within Vertex.Key Duties and Responsibilities:Lead/ facilitate all kinds of Drug Substance Product Events such as Lab OOS, Deviations, CAPA, Change Control Product Release.Be present at CDMO site as Person-In-Plant to review and approve product-specific protocols, reports, and Product Release and Distribution.Be part of the Pre-Approval Inspection Team, assisting CDMO site to be ready for successful global agency inspections.Provide quality assurance management in design and development activities of medical device products and facilitate the application of design controls and risk management.Support Design History File establishment, creation, approval, and maintenance.Perform Design History File audits at Phase Gates to ensure product development projects are in compliance with applicable design control regulations (21 CFR 820) and company policies and procedures.Review and approve design documentation including, but not limited to verification and validation methods, test plans, protocols and reports, test and inspection documents, design engineering drawings, statistical analysis methods, and risk documents (design and process).Support risk management activities including planning, design and clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting.Manage risk management file throughout the product development cycle.Review new and modified product designs for quality characteristics, including manufacturability, testability, reliability, biocompatibility, sterility, and conformance to product requirements.Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.Provide leadership in all areas of the Quality System, including, but not limited to Root Cause Analysis, CAPA, Nonconforming Material Investigations and Reporting, Deviations, Change Control, Supplier Qualifications, and Audit support functions (internal and external).Provide leadership in the understanding and communication of medical device regulations to other disciplines.Know and follow applicable FDA regulations and policies that apply to one's job, and maintain the highest level of professionalism, ethics, and compliance at all times.Knowledge and Skills:Direct hands-on experience in BIOLOGICS Drug Substance Manufacturing as Technical Quality Subject Matter Expert.Act as QA Technical Subject Matter Expert in global Regulatory Inspections.Create, author, and successfully close DS Product Deviations, Laboratory out of specifications, CAPAs.Created and implemented GMP process, facilities, equipment continuous plans.Review and release executed DS batch records for both clinical and commercial biologics products.Act as Person-In-Plant for DS Manufacturer.In-depth knowledge and experience in QC Analytical and/or Microbiology Testing.Implemented and used E-Quality Management Systems, Document Management System, Learning Management System.Possess excellent problem-solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations.Highly detail-oriented with strong organization and prioritization skills.Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint, etc.).Practical knowledge and experience with statistical methods, including sampling size justification using Minitab or other statistical software.Development and/or manufacturing experience.Familiarity with molding and assembly methodologies.ASQ certifications (Certified Quality Engineer, Certified Quality Auditor, Six Sigma).Working knowledge of ISO 13485, ISO 14971 and combination product standards.Blueprint literacy including GD&T.Education and Experience:Bachelor's degree in relevant field is required.Typically requires 6 years of experience or the equivalent combination of education and experience.Hybrid-Eligible RolesIn this Hybrid-Eligible role, you can choose to be designated as:Hybrid:

work remotely up to two days per week;

or select

On-Site:

work five days per week on-site with ad hoc flexibility.Pay Range:$0 - $0Disclosure 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.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.

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