Legend Biotech is seeking a Quality Assurance Operations Manager as part of the Quality team based in Somerset, NJ.

Role Overview

The Quality Assurance Operations Manager is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy to support clinical requirements in a sterile GMP environment. This role includes supervision of the Quality Assurance Shop Floor personnel as well as working with manufacturing to troubleshoot issues.

Key Responsibilities

Read, interpret, and revise documents such as SOPs and Work Instructions.
Develop a positive relationship with Quality Assurance, Quality Control, Information Technology, Engineering and Facilities, Technical Development, Regulatory, Human Resources, Site Leadership team members, and peers.
Harmonize with Environmental, Health, and Safety personnel, Technical Development, and Quality personnel.
Independently makes appropriate and compliant GMP decisions.
Independently resolves problems using Quality systems.
Develop improvement ideas and independently implements associated solutions.
Support QPIP team development.
Possess the ability to positively influence peers, key stakeholders, and management.
Generates shifts schedules to ensure efficient coverage for all operational needs.
Maintain individual training completion in a compliant state.
Supports the completion of corrective and preventative actions, as necessary.
Supports internal and external audits.
Review and approve documents as a Quality on the Floor Subject Matter Expert (SME).
Remain current skills and industry trends.

Requirements

Minimum of a Bachelor's Degree in Science, Information Science, or equivalent technical discipline is required.
Minimum of 6 years of relevant work experience is required.
Experience working in an aseptic manufacturing facility, preferably in Quality Assurance, Manufacturing Compliance, Clinical Quality, or Cell Therapy is preferred.
A minimum of 2 years of experience with quality support in clinical manufacture is preferred.
A minimum of 1 year of leadership experience is also required.
Knowledge of cGMP and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Ability to quickly process complex information and often make critical decisions with limited information.
Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities.
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 procedures.
Must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
Excellent written and verbal communication skills.
Ability to summarize and present results, and experience with team-based collaborations is a requirement.
Experience directly supervising employees is preferred.
Ability to work with and lead others in a team environment.
Demonstrated ability to develop and set long-term objectives.
Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
Ability to identify / remediate gaps in processes or systems.
Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
Experience reviewing/auditing documentation including but not limited to: Batch Records, SOPs, Work Instructions, Validation protocols.
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
Must have flexibility to work on weekends.

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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.