QA Manufacturing Excellence Manager
2 weeks ago
Legend Biotech is seeking
QA Manufacturing Excellence Manager
as part of the
Quality
team based in
Raritan, NJ.
Role Overview
The
QA Manufacturing Excellence Manager
role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process, equipment, and associated deviations and investigations within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide front line support to address and resolve manufacturing issues.
Key Responsibilities
Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of manufacturing operations and technical activities
Provide expertise and solutions to issues related to investigations and deviations occurring during routine manufacturing and protocol driven activities such as tech transfer and process validation
Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations
Assist in the development of process, operational, and quality improvements for manufacturing
Support manufacturing and technical operations teams in trouble shooting and resolving complex scientific / technical problems
Develops and evaluates quality processes and system standards to ensure compliance with applicable Janssen standards, industry standards, and global regulations.
Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions.
Point of contact for technical and manufacturing operations for quality oversight
Ability to work independently and successfully prioritize multiple tasks simultaneously
Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
Drive continuous improvement
Other duties may be assigned, as necessary.
Requirements
A minimum of a Bachelor’s Degree in Science or equivalent technical discipline is required
A minimum of 9 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A portion of the 9 years must include quality assurance experience.
Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in supporting cell-based products is a plus
Strong knowledge of cell therapy process preferred
Experience in cGMP regulatory body audits
Strong interpersonal and written/oral communication skills
Ability to quickly process complex information and make critical decisions with limited information
Ability to work independently and be responsible for a portfolio of ongoing projects
Ability to pay attention to details and follow procedures closely
Ability to identify and assess possible gaps and work collaboratively to address such issues
Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision
Experience reviewing/auditing GMP documentation
Strong proficiency with using Microsoft Office applications
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