Investigations Supervisor

Legend Biotech US•Raritan, NJ

12d•$110,706 - $145,303•Onsite

About The Position

Legend Biotech is seeking an Investigations Supervisor as part of the Manufacturing & Supply team based in Raritan, NJ. The CAR -T Investigation Supervisor will work with the investigation team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and resolution of deviations and atypical events. They will recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained.

Requirements

BS/BA required in technical discipline: Engineering, science or similar field.
A minimum of six (6) years of professional relevant business experience.
Demonstrated experience in completing complex investigations independently.
Knowledge and solid understanding of cGMP regulations and FDA/EU guidance
Ability to learn and operate various enterprise systems including eLIMS, TrackWise, Maximo, EMS, BMS, SAP.
Excellent written and oral communication skills
Ability to respond to sensitive inquiries or complaints from top managers, regulatory agencies, or members of the business community.
Experience with internal and external regulatory audits.
Ability to utilize various standard programs for data entry and word processing.
Language(s): English
Applicants must be authorized to work in the United States.
If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law.

Responsibilities

Support area Manager and work closely with investigators to ensure investigations are completed on time and as per guidelines.
Assign investigations to team members and track them to completion
Follow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.
Perform investigations and train new investigators.
Collaborate with team to determine if corrective actions adequately addressed root cause of NC event.
Support tracking of deviations, events and key process parameters and provides reports to management on trending, and status as requested.
Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
Implement process improvements within the change control system.
Recognize and act on potential compliance issues and opportunities for process changes/improvement.
Partner with all stakeholders to implement process improvements.
Assure regulatory compliance and technical feasibility of proposed changes.
Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.
Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
Maintains various databases of production information.
Support coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).
Review and approve SOP and Batch record revisions.
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals

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 just three (3) months of employment
Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Voluntary commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs