QA Batch Disposition Associate Manager

Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. 

Role Overview

This exempt-level position is responsible for performing a wide range of activities to support the release of drug products for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Key Responsibilities  

• Manage the team responsible for drug product batch record review and drug product release practices.
  
• Develop positive relationships with the QA team, Quality Control, Information Technology, maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.
  
• Independently makes appropriate and compliant GMP decisions.
  
• Lead the establishment and improvement of QA practices to ensure accurate documentation of all review and release activities for drug products, including manual and electronic practices.
  
• Establish and implement cGMP procedures to ensure compliant practices from all employees participating in the release process.
  
• Work in a team based, cross-functional environment to complete tasks required to meet business objectives.
  
• Support Investigations team by providing quality and compliance input for continuous improvement; and remediation's.
  
• Lead continuous improvement projects to reduce turnaround time for batch review / release.
  
• Require minimal direction to complete tasks, know how to attain resources and information from established internal contacts; consult with manager for decisions outside of established procedures.
• Provide direction to the batch review/ release team to meet department and business goals.
• Attend meetings and /or communicates regularly with stakeholders to report batch progress, quality batch review/ release project developments or stakeholder projects. Collaborate with (cross)functional departments to resolve issues related to batch review/release, investigations, and receipt of QC test results to allow for timely release of final product batches according to department and business plan.
  
• Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the batch review/release process.
  
• Manage cross-functional projects with stakeholders to establish best practices that will reassure the target turnaround time of a CAR-T product.
  
• Maintain quality practices in accordance with state and federal regulatory requirements.
  
• Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
  
• Ensure readiness of records for regulatory inspections and internal audits.
  
• Ability to utilize multiple electronic quality systems and SAP.
  
• Knowledge of cGMP regulations 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 oversee multiple priorities on a daily basis 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 the procedures
• Excellent written and verbal communication skills
  
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.

Requirements

• Bachelor’s degree required in Life Sciences or Engineering, with 6+ years.
  
• Biotech/Pharmaceutical experience or equivalent industry experience Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices diligence and ability to follow the procedures.
  
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
  
• Good written and verbal communication skills are required.
  
• Ability to collaborate well with stakeholders, customers, and peers. 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.
  
• 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 PowerPoints).
  
• Must have flexibility to work on weekends.
  
• Possess the ability to positively influence peers, key stakeholders, and management.
  
• Is frequently required to communicate with coworkers.
• Ability to lift 20 lbs.
• Report on working on time and according to the company policy.
  
• Perform other duties as assigned.
  
• Attend departmental and other scheduled meetings.
  
• Practice good interpersonal and communication skills.
  
• Demonstrate positive collaborative approach in the daily execution of procedures.
  
• Promote and work within a team environment.
  
• Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
  
• Strong proficiency utilizing electronic Quality Systems per curriculum.
  
• Utilizes tools within MS Office and other systems to improve business effectiveness.
  
• Support and contribute to projects.
  
• Assist in troubleshooting issues related to manufacturing and batch release.
  
• Interpret a variety of instructions furnished in written, oral, or diagram.
  
• Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process.
  
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Language: English

#Li-JK1