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Quality assurance
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Specialist
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance
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Quality assurance specialist
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Quality Assurance Manager
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Quality Assurance Project Assistant
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Quality Assurance Compliance Manager
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Quality Assurance Team Lead
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Quality Assurance Data Processor
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Vortex Companies Freehold, United StatesThe Vortex Companies, LLC deliver cutting edge trenchless technologies and turnkey services to make the worlds water cleaner. We cost effectively renew water, sewer, and industrial infrastructures. We provide a suite of services and products, including bypass pumping, lining and ...
Director, Quality Assurance - Raritan, United States - Legend Biotech
Description
Legend Biotech is seeking Director, Quality Assuranceas part of the Quality
team based in Raritan, NJ.
Role Overview
The
Director of Quality Operations
, CAR-T
is responsible for
Quality
oversight
and
support of
c
ell therapy manufacturing
operations
, in full complianc
e with established cGMP
requirements. Functions and activities include
Disposition
activities
, including
incoming
materials
and final
drug
product,
QA shop floor oversight of manufacturing operations,
Quality Assurance review and approval
functions,
and
QC laboratory oversight,
among others
.
The role develops and
implements long-term
and execution of Quality programs
. This role will also
be responsible for
trending of quality operations metrics and developing continuous improvement initiatives for the team and processes.
The Director also
manages a team of people leaders and technica
l professionals within the QA
department based on assigned work, direction, coaching and developing capabilities.
Key Responsibilities
Manage the daily quality activities for the quality operations team to ensure facility, process, and materials are in compliance with cGMP requirements.
Responsible for all aspects of incoming and final product disposition for the site.
Responsible for batch record review activities for the site.
Oversees quality shop floor program to ensure compliance of the manufacturing operations.
Responsible for providing quality oversight of the QC laboratory.
Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility.
Manages team of senior managers and professionals within Quality. Hires and develops employees within the department.
Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes.
Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Other duties will be assigned, as necessary.
Requirements
A minimum of a
Bachelor's Degree in Science
, Information Science or equivalent technical discipline is
required
.
A minimum of 14
years
relevant work experience is required.
It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Proven people management and leadership experience is required.
Experience working with quality systems is required.
Extensive knowledge of chemical, biochemical and microbiological concepts is required.
Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.
Ability to quickly process complex information and often make critical decisions with limited information.
Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
Proficient in applying process excellence tools and methodologies.
The candidate must be highly organized and capable of working in a team environment with a positive attitude.
Good written and verbal communication skills are required.
Ability to summarize and present results, and experience with team-based collaborations is a requirement.
Experience developing and setting long-term objectives.
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.
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
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