GMP Operational Quality Manager; QA Ops QC

Position: GMP Operational Quality Manager (QA Ops for QC)
Job Description

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.

Key

Duties and 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

Knowledge and

Skills:

* 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)

Education and Experience:

* 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

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Pay Range:

$118,400 - $177,600

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey…