Vertex Pharmaceuticals
Associate Director, QA Technical GMP Drug Substance (Hybrid)
Vertex Pharmaceuticals, Seattle, Washington, us, 98127
Associate Director, QA Technical GMP Drug Substance (Hybrid)Job Description
General Summary:
The Associate Director Quality Technical GMP Drug Substance will be a hands-on QA Technical Subject Matter Expert and will collaborate with external CDMO’s, 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 the 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 comply with applicable design control regulations (21 CFR 820) and company policies and procedures.
Review and approve design documentation including verification and validation methods, test plans, protocols and reports, test and inspection documents, design engineering drawings, statistical analysis methods, and risk documents.
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 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 Root Cause Analysis, CAPA, Nonconforming Material Investigations and Reporting, Deviations, Change Control, Supplier Qualifications, and Audit support functions.
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, CAPA’s.
Create and implement GMP process, facilities, equipment continuous plans.
Review and release executed DS batch records for both clinical and commercial biologics products.
Implement and use 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 a relevant field is required.
Typically requires 8 years of experience or the equivalent combination of education and experience.
Pay Range:
$129,600 - $194,400
Company Information
Vertex 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.
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General Summary:
The Associate Director Quality Technical GMP Drug Substance will be a hands-on QA Technical Subject Matter Expert and will collaborate with external CDMO’s, 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 the 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 comply with applicable design control regulations (21 CFR 820) and company policies and procedures.
Review and approve design documentation including verification and validation methods, test plans, protocols and reports, test and inspection documents, design engineering drawings, statistical analysis methods, and risk documents.
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 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 Root Cause Analysis, CAPA, Nonconforming Material Investigations and Reporting, Deviations, Change Control, Supplier Qualifications, and Audit support functions.
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, CAPA’s.
Create and implement GMP process, facilities, equipment continuous plans.
Review and release executed DS batch records for both clinical and commercial biologics products.
Implement and use 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 a relevant field is required.
Typically requires 8 years of experience or the equivalent combination of education and experience.
Pay Range:
$129,600 - $194,400
Company Information
Vertex 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.
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