Commissioning and Qualification Project Manager

Job Description

Legend Biotech is seeking a Commissioning and Qualification Project Manager to oversee facility and equipment qualification for cell therapy manufacturing in Raritan, NJ. This role involves managing all aspects of the qualification program, ensuring GxP compliance, and building strong partnerships with various departments. The Commissioning and Qualification Project Manager will drive continuous improvements and efficiencies within Technical Operations.Responsibilities:

• Interface between Engineering and operating departments.
• Drive the establishment of processes ensuring safe, compliant, and efficient operation.
• Support and manage change controls, draft and review SOPs and protocols.
• Maintain assets in a qualified state.
• Develop/improve, implement, and execute the qualification program.
• Lead and direct qualification activities.
• Prepare Requests for Proposal (RFP) documents for 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 or equivalent.
• A minimum of 7 years’ experience in a regulated industry and 3 years’ experience of direct qualification project management.
• Experience working for a cell and gene therapy organization is preferred.
• 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.
• Must be able to manage shifting priorities to meet critical deadlines.
• Excellent teamwork and interpersonal skills.
• Advanced knowledge of facility operations.
• Maintains accurate working knowledge of governmental/regulatory requirements.
• Excellent organizational and communication skills.

Benefits/Offers:

• The anticipated base pay range for this is: $93,463 - $128,512 USD.