GMP Operational Quality Senior Specialist (Stability)

General Summary:

The GMP Operational Quality Senior Specialist is recognized as a subject matter expert in the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives. The role works with a high degree of independence and coordinates GMP activities to provide QA Analytical support for commercial product stability programs and executes routine tasks and activities in support of QA Analytical function.

Key Duties and Responsibilities:

• Provides QA review of the GMP data in support of commercial product stability as required.
• Has a good understanding of stability requirements per ICH and experience in stability protocol management.
• Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.
• Represents QA Analytical on cross-functional teams as an experienced Quality technical resource as needed.
• Supports quality oversight of Root Cause Analysis (RCA) and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. May approve investigations/CAPAs.
• Manages stability impacting change control activities such as assessment, implementation, and closure.
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reports.
• Supports external stability program activities for commercial products such as internal/external protocol review/approval, data review/approval and study initiation.
• Enforces Quality Agreements between CMOs/Suppliers and Vertex as applicable to stability study pulls, test initiation, data reporting and OOS/OOT management.
• Identifies and facilitates continuous improvement efforts.
• Identifies and communicates risks and assists with risk mitigation plans, where applicable.

Knowledge and Skills:

• Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting including knowledge of global GMP requirements in regard to GMP manufacturing and testing.
• Knowledge of basic analytical techniques in a Quality/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)
• Experience in supporting Quality Event Investigations, RCA and CAPA implementation.
• Experience in assessing and managing Change Controls
• Experience working with Contract Manufacturing Organizations (CMOs)/Contract Testing Organization (CTOs).
• Experience supporting multiple projects/teams, ability to work in a fast-paced environment and meet quality, accuracy and timelines.
• Demonstrated ability to evaluate quality matters and make decisions leveraging technical experience and judgement.
• Good communication skills (written and verbal) and the ability to communicate cross-functionally to a variety of audiences.
• Demonstrated ability to work independently to provide QA advice for large, multifaceted projects
• Experience in supporting Quality Event Investigations, RCA and CAPA implementation.
• Experience in assessing Change Controls
• Experience with electronic document management systems (e.g., LIMS, Veeva).

Education and Experience:

• Bachelor's degree in a scientific discipline (or equivalent degree) and 3-4 years of experience, or the equivalent combination of education and experience.
• Advance knowledge of GMP regulations and applicability.
• Operational QA experience in analytical or manufacturing setting, interpretation, and application of GMPs and applicable guidelines/guidance’s ex. ICH, USP, etc.
• Experience in Root Cause Analysis tools/methodology and technical writing.
• Facilitation/problem solving/organizational planning skills in a regulated environment.