CQV Supervisor

The role

This person will provide Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. They will handle day-to-day activities including execution, protocol management, vendor management, and remediation efforts for facility, equipment, systems and processes.

What you will do

• Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
• Manages multiple and complex CQV projects.
• Supports and/or owns technical and quality investigations, CAPAs and corrections.
• Develops and performs any required remediation efforts and associated CAPA plans.
• Authors, owns and executes master and completed CQV protocols, summary reports and associated data.
• Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.
• Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.
• Train and support the junior team members on different CQV activities.
• Present CQV work to regulatory and internal audit teams.
• Making decision on corrective action in deviation events.

Required qualifications

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline
• Minimum of 7 years relevant work experience
• Ability to use Microsoft suite
• Ability to use ERP systems: Maximo, Siemens EMS, Comet, Kneat
• Ability to use Testing system: Kaye AVS, Kaye Valprobe
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products
• Knowledge of Good Tissue Practices
• Strong interpersonal and written/oral communication skills
• Ability to quickly process complex information and make critical decisions with limited information
• Proficient in applying process excellence tools and methodologies
• Ability to independently be responsible for a portfolio of ongoing projects
• Ability to pay attention to details and follow the procedures

Nice to have

• Experience working in an aseptic manufacturing facility
• Experience in cell therapy, testing facility, quality assurance, or manufacturing compliance
• Experience with 21 CFR 600, 601, and 610

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight (8) weeks of paid parental leave after three (3) months of employment
• Vacation time
• Personal time
• Sick time
• Floating holidays
• Eleven (11) company holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance

Before you apply

• Applicants must be authorized to work in the United States
• Employment eligibility will be verified through E-Verify

About the company

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, they are advancing the next generation of cell therapy through a portfolio of innovative technologies.