GMP Operational Quality Manager

General Summary:

The GMP Operational Quality Manageris an advanced technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Quality Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

This hybrid position is based onsite at our Boston Seaport HQ (3 days onsite and 2 days flexible).

Key Duties and Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to manufacturing operations 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.

Knowledge and Skills:

• 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.

• 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).

Education and Experience:

• Bachelor’s degree in a scientific or allied health field with 5+ years of relevant work experience, or the equivalent combination of education and experience.

• Experience providing Quality support and oversight of GMP manufacturing operation including batch disposition.

• Experience with drug substance, spray dried dispersion (SDD) and drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting.

• Knowledge of cGMP requirements governing oral drug products manufacturing practices.

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