GMP Operational Quality Manager (QA Ops for QC)

Vertex Inc.•Boston, MA

3d•Onsite

About The Position

General Summary: The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. The role will also have responsibilities associated with QC data review for both non-routine and routine cGMP process testing and in support of stability testing of Cell & Genetic Therapy products. This role requires collaborative interaction with cross-functional partners such as analytical and process development, clinical and commercial QC, and manufacturing operations to ensure the on-time closure of deviations, CA/PA, and change controls. This QA position will work with internal and external QA teams and QC labs ensuring adherence to compliance while supporting both clinical and commercial release and stability testing of a genetically edited cell therapy product. The position will provide compliance support to both clinical and commercial data review and data management. This person will support QA activities related to GMP release and stability as well as lifecycle improvement for methods related to raw material, in-process, and drug product samples. The GMP-facing nature of this work requires keen attention to detail and understanding of analytical compliance expectations.

Requirements

Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting
Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines.
Ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint
Ability manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes
Formal project management experience
Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences.
Able to integrates activities with other groups, departments and project teams as needed.
Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions
Excellent team player and collaborator
Highly proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
Bachelor's degree in scientific or allied health field (or equivalent degree)
Typically requires 4+ years of experience, or the equivalent combination of education and experience

Responsibilities

Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions
Lead root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
Perform change control assessments and closure approvals
Establish and revise Quality Agreements between CMOs/Suppliers and Vertex, as needed
Collect data and report on metrics
Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills.
Lead continuous improvement projects
Authors and reviews data, SOPs, COAs, analytical methods, protocols, and reports.
Assist with regulatory agency inspections
Identify and facilitate continuous improvement efforts
Support the lead point of contact for QA activities occurring at multiple contract manufacturing and test organizations, including release & stability testing, method equipment/software validation, and adherence to project timelines.
Support QA operations for a gene edited hemoglobinopathy cell therapy product and helps troubleshoot technical aspects of analytical methods related to the release of biologics and cell therapy products.
Ensures all external laboratory records adhere to cGMP/GDP expectations.
Supports compliance related teams working towards the goal of continuous improvement.
Assists with OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence