Full-Time

Risk Assessment Specialist

Posted on 4/27/2024

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops cell therapies for cancer treatment

Biotechnology

Mid

Bridgewater Township, NJ, USA

Requirements
  • BS/BA required in technical discipline: Engineering, science or similar field.
  • Pharmaceutical/Life Sciences project management professional plus a minimum of 1 year of project management experience in the pharmaceutical industry with Project Management Professional (PMP) certification or equivalent is desirable.
  • Understanding of manufacturing processes and quality risks, and experience in pharmaceutical GMP Manufacturing Operations is a plus.
  • Proficiency in MS Office, MS Project and other project management tools.
  • Strong analytical skills and business acumen.
  • Cross functional collaboration skills with the ability to network with different functional areas and integrate cross functional deliverables.
  • Strong oral interpersonal and written communications skills.
  • Must have experience in risk assessment tools (e.g. FMEA, FTA, Pareto analysis, HAZOP, HACCP).
  • Project Management or quality or manufacturing background.
  • Ability to engage all levels of the organization, from site leadership to the shop floor.
  • Proven experience working and leading in a matrix environment.
  • Ability to lead with influence.
  • Able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment, while providing clear direction to team members.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Change management.
  • Excellent organizational and communication skills.
Responsibilities
  • Follow QRM (Quality Risk Management) process per ICH Q9, identify the risk, analyze the risk, evaluate the risks and work resources to control the risks based on failure analysis results.
  • Plan and implement Risk Assessment, support define Risk Assessment scope, goals, deliverables; and define tasks and required resources.
  • Serve as leader and prime advocate for your Risk Assessment, design, manage, support and direct risk assessment team.
  • Manage stakeholders, create schedule and risk assessment timelines, track deliverables and monitor and report on risk assessment progress.
  • Present to leaders reports on progress as well as problems and solutions, and implement and manage change when necessary to meet risk assessment outputs.
  • Lead issue-oriented Risk Assessment meetings; mediate and resolve conflicts; and drive teams to success.
  • Follow-up on action items between team meetings and ensure accountability of team members.
  • Interface with all levels of management and ensure alignment throughout the organization.
  • Be a model of superb organization, excellent timeliness and tireless follow-up.

Legend Biotech specializes in developing and manufacturing novel cell therapies for hematologic malignancies and solid tumors, leveraging cutting-edge technologies to deliver advanced treatment options for patients worldwide. The company's pipeline of cell therapies includes agents targeting diseases considered intractable and incurable, with a focus on transforming the world of oncology and medicine.

Company Stage

IPO

Total Funding

$750.5M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

21%

1 year growth

50%

2 year growth

132%