• Provides QA review of the GMP data in support of stability of commercial and clinical products.
• Supports quality oversite of root-cause analysis and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. Approves investigations/CAPAs.

• Represents QA Analytical on cross-functional teams as an experienced Quality technical resource.
• Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.
• Supports change control assessment, implementation, and closure. Assesses and approves change controls.
• Supports analytical method validation and transfer activities for commercial and clinical products.
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports.

• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed
• Support continuous improvement projects. May facilitate or leads improvement efforts.
• Supports generations and maintenance of Quality Metrics to support process improvement activities as necessary.
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Supports internal audit or external audit programs as necessary

• Assists in preparation of audit responses as necessary

• Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing and testing.
• Strong knowledge of basic analytical techniques in a QC/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)
• Expirience with supporting/managing stability related activities in QC/QA settings.
• Experience working with CMO/CTO’s.
• Experience in leading and Event Investigations, Root Cause Analysis (RCA), and monitor CAPA implementation.

• Experience supporting multiple projects/teams, ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives

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  Good communication skills (written and verbal) and the ability to communicate cross-functionally to a wide variety of audiences.

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  Demonstrated ability to work independently to provide QA advice for large, multifaceted projects

• Demonstrated ability to evaluate quality matters and make decisions leveraging technical experience and judgement.
• Experience in assessing Change Controls
• Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva).

• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically requires 2-4 years of experience, or the equivalent combination of education and experience
• Advance knowledge of GMP regulations and applicability to duties.
• Operational QA experience in analytical or manufacturing setting, interpretation, and application of GMPs and applicable guidelines/guidance’s ex. ICH, USP, etc.
• RCA tools/methodology/ technical writing

• Facilitation/ problem solving /organizational, planning, etc

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. 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 ApplicationAssistance@vrtx.com.