GMP Operational Quality Manager

Key Responsibilities

• Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to analytical testing at contracted suppliers.
• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed.
• Assists Change Control owners with ensuring compliance to change procedure requirements, assesses and approves change controls.
• Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
• Ensures appropriate CAPA actions are identified and addressed. Approves investigations/CAPAs.
• Identify, facilitate, and/or lead continuous improvement efforts.
• Maintains Quality Metrics to support process improvement activities.
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports.
• Performs disposition activities in support of Commercial products.
• Responsible for coordinating, facilitating and follow up on any QLT action items assigned.
• Identify and communicate risks and assist with risk mitigation plans as necessary.
• Supports internal audit or external audit programs. Assists in preparation of audit responses.
• Manages audit CAPAs & metrics. Provides technical advice for partner and regulatory agency audits.

Minimum Qualifications

• In-depth 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 analytical lab testing.
• Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives.
• Experience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks.
• Ability to independently lead cross-functional teams and represent the Quality unit.
• Ability to mentor and guide staff, skilled at transferring technical knowledge and teaching quality management skills.
• Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information and is able to influence others to understand a point of view and gain alignment around a proposed action.
• Demonstrated ability to work independently to provide QA advice for large, multifaceted projects.
• Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience, advanced judgement and the analysis/synthesis of a variety of information; able to work outside of precedent and takes a new perspective on existing solutions.
• Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
• Strong experience with electronic document management systems (e.g., Veeva).