-
QA Manufacturing Excellence Manager
4 days ago
Legend Biotech US Raritan, United States**Company Information** · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, includ ...
-
Commercial Excellence Manager
1 week ago
Brenntag South Plainfield, United States**COMMERCIAL EXCELLENCE MANAGER - PHARMA**: · Our team in **South Plainfield** currently has an opening for a **Commercial Excellence Manager - Pharma** · **YOUR ROLE & RESPONSIBILITIES**: · **Job Summary**: · Commercial Excellence department at Brenntag Specialties is looking fo ...
-
QA Manufacturing Excellence Manager
2 weeks ago
Legend Biotech US Raritan, United StatesCompany InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including aut ...
-
QA Manufacturing Excellence Manager
2 weeks ago
Legend Biotech US Raritan, United StatesCompany InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including aut ...
-
Manager Operational Excellence
1 week ago
Lupin Somerset, United StatesThe Manager Operational Excellence (Op. Ex) reports directly to the Site Head and Vice President of Operations and will head and control the Op. Ex Department for Lupin's Somerset facility. Will oversee the work of cross functional managers and their Manager, Continuous Improveme ...
-
Manager Operational Excellence
6 days ago
Lupin Pharmaceuticals Somerset, United StatesOverview: · Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus ...
-
Veterinary Hospital Manager
1 week ago
PetVet Care Centers Raritan, United States**Position Overview**: The Hospital Manager works daily to develop an efficient and effective hospital support team by fostering an environment of trust, teamwork, and accountability. The Hospital Manager partners with the Veterinarian to provide an efficient and profitable opera ...
-
Johnson & Johnson Raritan, United StatesJohnson & Johnson is currently seeking a Director of Lenti Virus Operations Optimization and Competitiveness to join our TEAM · Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strate ...
-
Document Specialist
1 week ago
Proempire LLC / Vitamatic Raritan, United States**Job Overview**: · An entry-level position to manage food safety and quality of incoming raw materials and finished goods to assure a high level of product quality within the established company/industry standards. · **Responsibilities**: · - Create, support, review, update, fil ...
-
Operation Coordinator
6 days ago
Proempire LLC / Vitamatic Raritan, United States**Job Overview**: · Manage the backend operations of all channels and ensure the data is up-to-date and functioning. Provide administrative support to the ecommerce operations team as needed. · **Responsibilities**: · - Oversee the day-to-day performance of marketplaces such as A ...
-
Chargeback Analyst
2 weeks ago
Johnson & Johnson Raritan, United StatesJohnson & Johnson Health Care Systems, Inc. is recruiting for a Chargeback Analyst-Enterprise Contract Management (ECM), to be located in Raritan, NJ · Johnson & Johnson Health Care Systems Inc. (JJHCS) provides contracting, supply chain, business services, and strategic solution ...
-
Executive Assistant, Transformation Office
1 week ago
Johnson & Johnson Raritan, United StatesJohnson & Johnson is recruiting for an Executive Assistant, Transformation Office in Raritan, NJ or near a Johnson & Johnson office in India, Switzerland, Belgium, or the United States. · - Per our J&J Flex Policy, the expectation for this position is to work in the nearest Johns ...
-
Executive Administrative Assistant
2 weeks ago
Johnson & Johnson Raritan, United StatesJohnson & Johnson is recruiting for an Executive Administrative Assistant in Raritan, NJ. · - Per our J&J Flex Policy, the expectation for this position is to work in office 3-4 days per week and work from home 1-2 days per week. _ · The Executive Administrative Assistant support ...
-
Johnson & Johnson Raritan, United StatesJ&J Innovative Medicines is recruiting for an Associate Director, Launch and Strategic Operations - Global Oncology, located in Raritan, NJ · The Associate Director - Launch and Strategic Operations will support efficient global launch plans and ensure organizational readiness. T ...
-
Car-t Logistics Specialist
2 weeks ago
Johnson & Johnson Raritan, United StatesJanssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR T Warehouse Logistics Specialist located in Raritan, NJ. #CART · Primary responsibilities include, but are not limited to, managing all international shipping activities in ...
-
Project Manager
1 week ago
Sthree Raritan, United StatesExciting Project Management consultant opportunity with Johnson & Johnson in Raritan, NJ. This opportunity is ideal for PMs with supply chain and pharma/OTC/consumer goods experience. · Title: Project Manager, Life Cycle Management · Industry: Pharma/Med Tech · Work Mode: Hybrid ...
-
Customer Service Support Team Lead
2 weeks ago
Labcorp Raritan, United States**Work Schedule**:Your planned work schedule will be Monday - Friday (9:00am-5:30pm) and alternating Saturdays (7:30am-4:00pm). The hours/location may change/vary based on business need and/or the request(s) of your supervisor or management. · **Work Location**: Raritan, NJ · **R ...
-
Executive Administrative Assistant(Calendar
5 days ago
Infobahn Softworld Inc Raritan, United States**Description**: · - Provide support with calendar management, meeting support, expense reports, org. charts, distribution lists, Totality requests, partnering and working as a team with other admins on team and assisting Executive Admin Asst., as needed with all admin duties. · ...
-
Manager, Technology Operations
1 week ago
Johnson & Johnson Raritan, United StatesPer our J&J Flex Policy, the expectation for this position is to work in the nearest Johnson and Johnson office 3-4 days per week and work from home 1-2 days per week. _ · Enterprise Quality is a comprehensive organization within J&J that focuses on ensuring the highest standards ...
-
Medical Courier/route Driver-part Time
5 days ago
Labcorp Raritan, United States Part timeAt Labcorp we have a passion in helping people live happy and healthy lives. Every day we provide vital information that helps our clients and patients understand their health. If you are passionate about helping people and have a drive for service, then Labcorp could be a great ...
QA Manufacturing Excellence Manager - Raritan, United States - Legend Biotech
Description
Legend Biotech is seekingQA 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 ResponsibilitiesProvide 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.
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
#LI-NP
#J-18808-Ljbffr
