Manager, R&D Quality Systems

Manager, R&D Quality Systems

6-month contract

Cambridge, MA - Hybrid 3 days/week

$70-80/hr.

About our Client:

Our client is focused on utilizing engineered cells as medicines for patients. The ability to modify genes and use cells as medicines will be one of the most important advances in healthcare over the next several decades. Our client is building differentiated capabilities across the spectrum of cell and gene therapy.

About the Role:

This Contractor’s primary role is to support R&D functions in Quality Systems and reports to the Associate Director of GxP Quality Systems. The scope of work will focus on Document Management, Training Administration, and Deviations/CAPA supporting R&D including laboratory, clinical and development teams.

Duties and Responsibilities:

• Management of GxP Quality Systems with a focus on GCP/GLP requirements, including input into GxP Policies and Procedures covering Deviation and CAPA process, Change Management, Training Administration and Document Management. Contribute to process improvement initiatives within Quality Systems.
• Serve as Training Administrator for R&D teams, support development of training curriculum, assignment of training and maintenance of training requirements in Veeva.
• Serve as Document Control (Veeva) for R&D Quality providing guidance to users, approve document change controls, and oversee document management activities with training impact.
• Monitor and report metrics for R&D Quality System Health Indicators as part of management review.
• Support maintenance and improvement of the client's Risk Management and Data Integrity Programs.
• Demonstrate ability to engage and effectively influence team members across multi-disciplinary groups while prioritizing multiple projects and meeting deadlines.
• Drive curiosity and risk-based decision making, and demonstrate excellent problem solving skills across a fast paced performance-driven environment.

Qualifications:

• BA or BS in Life Science Degree.
• 8 years of experience in the pharmaceutical or biotechnology industry in Quality Assurance or equivalent combination of education and work experience.
• Demonstrated experience in Quality Systems functions within a GMP facility of cell/gene therapy products or biologics in clinical and/or commercial settings.
• Experience in early phase development.
• Previous experience in Quality Management Systems (Document Management, Training Administration, Deviations, CAPA, Change Control, Risk Management, Quality Management Review).
• Ability to effectively prioritize and deliver high-quality results on tight timelines.
• Strong understanding of quality structure and design principles, with experience managing Quality Systems across GxPs, with emphasis on R&D quality.
• Detail-oriented with the ability to multi-task, prioritize, and work effectively in cross-functional team environments.
• Clear and effective communicator, both verbally and in writing.
• Demonstrated expertise with Veeva Vault and in the deployment/validation of GxP systems.
• Proficiency with MS Office (Word, Excel, PowerPoint) and Smartsheet.
• Ability to work effectively in both remote and onsite environments.