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Associate Director, Quality Systems

Legend Biotech US
Location
Raritan, New Jersey, United States
Posted
25 days ago
Department
Quality Systems & IT
What they actually want (must-haves)
  • Bachelor’s degree in Science, Engineering, Biotechnology, Pharmacy, Information Science, Biology, or a related technical discipline
  • Minimum 10 years of Quality experience within a cGMP-regulated manufacturing facility, biotechnology, biopharmaceutical, or Cell & Gene Therapy manufacturing environment
  • Demonstrated experience leading quality systems, complex investigations, CAPA programs, governance programs, quality improvement initiatives, cross-functional projects, and regulatory inspection or audit readiness activities
Nice to have
  • An advanced degree
What the job really is

The Associate Director, Quality Systems will oversee quality systems within a cell therapy manufacturing plant, ensuring compliance with commercial requirements in a sterile GMP environment. This role involves managing a team responsible for document control, investigations, CAPA, change control, and quality metrics, while also supporting regulatory inspections and site quality compliance. The position requires collaboration across various departments to enhance productivity and compliance through effective risk management and continuous improvement initiatives.

Benefits
  • Medical, dental, and vision insurance
  • 401(k) retirement plan with a company match that vests fully on day one
  • Eight weeks of paid parental leave after three months of employment
  • Paid time off policy including vacation time, personal time, sick time, floating holidays, and eleven company holidays
  • Voluntary benefits including flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans
  • Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs
Things to weigh
  • No specific mention of the technologies or tools used in quality systems management
  • The role requires minimal direction, which may indicate a high level of autonomy and responsibility
  • The position is based in a sterile GMP environment, which may involve strict regulatory compliance challenges
Job score3.2/5
Benefits3/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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