Commissioning and Qualification Project Manager

Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

 This position is responsible for the qualification of facility and equipment for new projects and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program overseeing facilities, utilities, and equipment for Legend Biotech. The position is responsible for ensuring that the qualification activities are performed within an appropriate level of GxP compliance. This individual will need to build strong partnerships with Engineering and Facilities, Manufacturing, Quality Control and Quality Operations to drive continuous improvements and efficiencies within cell therapy Technical Operations.

Key Responsibilities  

• Interface between the Engineering group and the operating departments to address internal stakeholder needs ensuring that all asset qualification activities are properly supporting for manufacturing, quality control, supply operations and for the site’s requirement.
• Drive the establishment of the aforementioned processes, while ensuring a safe, compliant, and efficient operation with the establishment of appropriate controls and traceability according to cGMP requirements.
• Support and manage change controls, draft and review SOPs and protocols, support technical investigations, and implement CAPAs to address compliance requirements.
• Responsible for maintaining assets in a qualified state in accordance with quality standards, Good Manufacturing Practices, and OEM guidelines.
• Develop/improve, implement, and execute the qualification program for Legend Biotech.
• Lead and direct qualification activities to meet company goals, quality, and regulatory objectives. Qualification team will consist of managing external resources and some internal resources.
• Ensure safety, quality, and compliance is the main goal for all new and existing qualification projects.
• Prepare Requests for Proposal (RFP) documents for vendors to bid qualification work. Provide vendor comparisons and award qualified vendors.
• Provide SME support for regulatory inspections and regulatory filings.
• Author/Review/Approve documents for departmental standard operating procedures (SOPs) and programs.
• Generation and execution of qualification documents URS, RA, SAT, FAT, IQ, OQ, PQ, and summary reports to support GxP requirements.
• Review of new qualification project proposals and project prioritization/scheduling efforts to keep activities aligned to corporate objectives.
• Ensures necessary communication within the project engineering team and collaborate with other departments (Manufacturing, Quality, Regulatory, Development, Finance, and IT) on qualification deliverables.
• Provide qualification project updates to stakeholders and management personnel, such as phase gate reviews, meeting minutes, status updates, and identification and tracking of project risks.
• Demonstrate effective project leadership and team collaboration by completing all assigned projects on-time, on budget and successfully achieving qualification expectations in compliance with our safety policies and company regulations.
• Manages / oversees external vendors to ensure qualification activities are maintained to the highest standards.
• Author and execute Change Controls and Impact Assessments for Engineering/Facilities qualification projects.
• Participate and lead in the development of corporate-wide systems, procedures, and tools that facilitate efficient processes throughout the organization.

Requirements

• B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field or equivalent work experience. Trade / Technical School Certification or Certification in Craft. Military equivalent of Trade / Technical School certification.
  
• A minimum of 7 years’ experience in a regulated industry and 3 years’ experience of direct qualification project management. Preferred candidate would have previous experience working for a cell and gene therapy organization.
  
• Must be able to read drawings, schematics, and isometrics. Must have basic computer skills in Microsoft Word, Excel, and PowerPoint. Must be proficient utilizing a computerized maintenance management program and qualification software.
  
• Cell/Gene Therapy experience preferred.
  
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
  
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
  
• A history of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning.
• Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization.
  
• Advanced knowledge of facility operations including best industry practices, application of principles, concepts, practices, standards, validation, and qualification within a cGMP manufacturing environment.
  
• Maintains accurate working knowledge of governmental/regulatory requirements as related to equipment including EPA, OSHA, and the FDA. Monitors and ensures company compliance with regulatory standards.
  
• Excellent organizational and communication skills.

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