QA Project Manager, PQA

Position Overview

The QA Project Manager, Program Quality Assurance (PQA) is responsible for providing the PQA team with assistance and oversight of QA projects. As projects evolve and startup activities develop, this position adapts its responsibilities to meet changing needs. The QA Project Manager, PQA focuses on establishing, facilitating, and delivering key performance indicators (KPI), continuous improvement and risk management activities in support of site readiness for operations, start-up and ongoing operations. This role is responsible for administering policies, and effectively addressing and mitigating any issues encountered during assigned activities. 

Job Description

What You'll Do

• Assists Head of Project QA with development and maintenance of Key Performance Indicators for QA Project Delivery to optimize project outcomes• Develops a comprehensive project management workflow, and ensures regular updates are communicated to internal and external stakeholders on project schedules, change proposals, and other activities• Serves as Subject Matter Expert (SME) within the QA team, developing and maintaining metrics, look-aheads, reporting processes, andproject deliverable tracking tools to enhance forecasting and project schedules for QA Project Delivery• Establishes and facilitates QA readiness processes and plans for site cGMP go live across the business functions and site buildings• Establishes KPI, continuous improvement processes and risk management processes in support of project delivery and site readiness• Serves as Subject Matter Expert (SME) within the QA team for developing, maintaining and reporting forecasting models, metrics and KPIs• Supports QA team with oversight and support of project deliverablesin accordance with governing processes• Ensures project and operational quality objectives are met within desired timelines, contributing to team success• Collaborates with other FUJIFILM Diosynth Biotechnologiessitesto streamline processes and enhance operational efficiency, while actively leverages best practices and maintains alignment with our sister site in Denmark• Participates in and drives optimization and improvement initiatives• Creates projectschedules and timelines, and assists with budget tracking• Monitors project progress, identifies and addresses any issues or challengesthat arise• Maintains comprehensive and accurate project documentation, including reports, forecasts, logs, and records• Performs other duties, as assigned

Minimum Requirements:

• BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR• MS in Life Sciences or Engineering and 3+ years of applicable experience OR• PhD in Life Sciences or Engineering with 1+ years of applicable experience

• Proven experience in project management, preferably in GMP Quality Assurance and/or similar role, required• 3+ years of experience in GMP operationsin an FDA regulated facility

Preferred Requirements:

• Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, Veeva, SAP, and/or Kneatvalidation software• Previous biopharmaceuticals experience:     o cell culture, upstream processes, large scale recovery

     o Experience with startup projects or initiatives     o Training and/orfamiliarity with Quality Risk Management principles     o Validation, cGMP manufacturing operations and/or Quality oversight

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to stand for prolonged periods of time up to 30 minutes.

Ability to sit for prolonged periods of time up to 120 minutes.

Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.