C&Q Supervisor

Contenido de trabajo

Position Overview

This position will be part of the CAR-T Asset Management team within the Technical Operations group and will be responsible for performing and coordinating Commissioning and Qualification activities within the cGMP Clinical and Commercial Cell Therapy Manufacturing plants in Ghent (Belgium).This individual will be responsible for leading and overseeing day-to-day C&Q activities inclusive of protocol management & execution, management and periodic review of user access and audit trail, periodic system quality review for CAR-T process and lab equipment in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require people management skills, engineering and C&Q experience, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Major Responsibilities

• Responsible for leading and overseeing day-to-day C&Q activities inclusive of protocol management & execution, management and periodic review of user access and audit trail, periodic system quality review for CAR-T process and lab equipment in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements.
• Manages multiple and complex C&Q projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
• Prioritize the use of internal and external resources to most effectively achieve business goals and within budget.
• Develop, lead & coach a team of C&Q Engineers to ensure that all critical production process and lab equipment and systems (assets) in all areas of responsibility comply with all company and/or site Quality & EHS policies and procedures, user requirements, local and federal regulations (e.g., FDA/EU cGMP) and industry standards, guidance and expectations.
• Maintain knowledge of and compliance to all applicable codes and regulations as required.
• Responsible for the planning, execution, tracking and reporting of status and risks/issues associated with C&Q activities for CAR-T production process and lab equipment.
• Coordinates with other departments and/or outside contractors/vendors (if applicable) in case of issues
• Supports in authoring CARA documents (Critical Aspects Risk Assessments), T&TM’s (Test & Traceability Matrices), Periodic Qualifications, Project Plans, Master Plans, and PSQR’s (Periodic System Quality Reviews).
• Supports in execution of commissioning, qualification, requalification and any associated engineering activities within the plants.
• Supports and/or owns technical investigations detected during C&Q activities.
  
  

Qualifications:

Education

• A minimum of a Master’s Degree in Science, Engineering, Bioengineering or equivalent technical discipline is required.
  
  

Experience

• A minimum of 3 years relevant C&Q and people oriented work experience within a cGMP environment. It is preferable that the candidate has experience working in an Aseptic manufacturing facility.
  
  

Capabilities, Knowledge, And Skills

• Proven people management skills.
• Detailed knowledge and understanding of cGMP, FDA/EU and Industry regulations, standards, guidance and expectations.
• A thorough understanding of Good Engineering Practices (GEP), technical installations, equipment, facilities and (computerized) systems within the Life Science Industry.
• Ability to work independently and successfully, prioritize and manage multiple projects and tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Ability to pay attention to details and follow procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Strong interpersonal and written/oral communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Proficient in applying process excellence and QRM tools and methodologies.
• Build strong partnerships with Operations, Manufacturing Excellence and Quality to ensure seamless implementation of Engineering and Maintenance projects and/or process improvements.
• Ability to identify/remediate gaps in processes, equipment, facilities and systems.
• Experience in authoring and executing documentation including, but not limited to: (electronic) Batch Records, SOPs, Work Instructions, C&Q documents.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
• Experience with SAP, Change Control system and DMS is preferred.
  
  

Language(s)

• Dutch/English
  
  

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.