QA Manufacturing Excellence Manager

2 weeks ago


Raritan, United States Legend Biotech Full time

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

#LI-NP

#J-18808-Ljbffr



  • Raritan, United States Legend Biotech Full time

    Legend Biotech is seeking QA Investigations Supervisor (2nd shift) as part of the Quality team based in Raritan, NJ. Role Overview The QA Investigations Supervisor has the responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This...


  • Raritan, United States Legend Biotech USA, Inc. Full time

    The QA Shop Floor Supervisor is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This ro QA, Floor Supervisor, Shop, Supervisor, 2nd Shift, Manufacturing, Technology


  • Raritan, United States Johnson & Johnson Full time

    Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Manufacturing Operator located in Raritan, NJ. #CART : This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the...


  • Raritan, United States Delta Community Supports Full time

    **Join us at Delta Community Supports, Inc. (“Delta”), where every day brings the opportunity to make a difference in the lives of others! As a leading provider of support services for individuals with intellectual and developmental disabilities, we're on a mission to empower and enrich the lives of those we serve. Are you passionate about fostering...


  • Raritan, United States CareerBuilder Full time

    Legend Biotech is seeking Sr. Associate OpEx Engineer as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for providing operational excellence continuous improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous improvement...


  • Raritan, New Jersey, United States Johnson & Johnson Full time

    Janssen Research & Development, LLC, is recruiting for a Site Manager, Global Clinical Operations - Oncology to be remote in the Western Region ( AZ, CA, CO, ID, MT, NE, ND, NM, NV, OR, SD, UT, WA, WY, HI, AK) of the United States. A Site Manager I (SM I) serves as the primary contact point between the Sponsor and the Investigational Site. A SM I is...


  • Raritan, United States Piper Companies Full time

    Piper Companies is currently looking for an experienced Sr. Financial Analyst to in Raritan, NJ ( Hybrid Remote Schedule ) to work for an innovative and growing pharmaceutical organization. This role will be responsible for key planning, monitoring, reporting, and controlling of budget and investments. Responsibilities for the Sr. Financial Analyst include:...


  • Raritan, New Jersey, United States Johnson & Johnson Full time

    Johnson & Johnson is recruiting for a Manager of Engineering in Quality, Compliance, and Labs (QCL) headquartered in Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company. Applicants must be willing to work on Eastern Time zone schedule. At Johnson & Johnson, we believe health is everything. Our...

  • Training Supervisor

    4 weeks ago


    Raritan, United States Legend Biotech Full time

    Legend Biotech is seeking Training Supervisor - Operations as part of the Training team based in Raritan, NJ. Role Overview The position will be responsible for supervising the training team who lead training activities for the overall plant team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will oversee the...


  • Raritan, New Jersey, United States Proclinical Full time

    QC Investigation Specialist (Level 1, 2, 3, & Senior) - Contract - OnsiteProclinical Staffing is seeking a QC Investigation Specialist (Level 1, 2, 3, & Senior) to join a global biotech company. This is a contract role located in Raritan, NJ.Primary ResponsibilitiesThe QC Investigations Specialist, CAR-T Manufacturing is an exempt level position with...


  • Raritan, United States ilb Consulting Services Full time

    00749 Global Brand Protection Group - Services Manager Consultant CONTEXT One of the largest Global Healthcare Companies needs a Consultant in a role similar to an IT Service Manager to work with the Global Brand Protection Group (GBP). Background/Responsibilities/Requirements GBP works across the organization to disrupt the fraudulant supply chain of...

  • MBR Engineer

    1 day ago


    Raritan, United States Ztek Consulting Full time

    Job Title: MBR EngineerLocation: Raritan, NJJob Description:Position Overview: As a Senior MES PAS-X MBR Modeler you will play a critical role in the design, implementation, and maintenance of our MBR using Werum PAS-X V2/V3. You will ensure compliance with industry standards and regulations while optimizing production processes.Key Responsibilities:·...

  • MBR Engineer

    1 day ago


    Raritan, United States Ztek Consulting Full time

    Job Title: MBR EngineerLocation: Raritan, NJJob Description:Position Overview: As a Senior MES PAS-X MBR Modeler you will play a critical role in the design, implementation, and maintenance of our MBR using Werum PAS-X V2/V3. You will ensure compliance with industry standards and regulations while optimizing production processes.Key Responsibilities:·...

  • MBR Engineer

    1 day ago


    Raritan, United States Ztek Consulting Full time

    Job Title: MBR EngineerLocation: Raritan, NJJob Description:Position Overview: As a Senior MES PAS-X MBR Modeler you will play a critical role in the design, implementation, and maintenance of our MBR using Werum PAS-X V2/V3. You will ensure compliance with industry standards and regulations while optimizing production processes.Key Responsibilities:·...


  • Raritan, United States ILB Consulting Services Full time

    Job DescriptionJob Description00749 Global Brand Protection Group - Services Manager Consultant CONTEXT One of the largest Global Healthcare Companies needs a Consultant in a role similar to an IT Service Manager to work with the Global Brand Protection Group (GBP). Background/Responsibilities/Requirements GBP works across the organization to disrupt the...


  • Raritan, United States Source One Technical Solutions Full time

    Job DescriptionJob DescriptionSource One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global pharmaceutical company in Raritan, NJ.Title: Information Security and Compliance Consultant (Contract)Pay Rate: $81/hr (W-2)Initial Duration: 1 yearSchedule, M-F, 40...


  • Raritan, United States PetVet Care Centers Full time

    **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 operation by driving revenue and managing costs while creating a hospital culture...

  • Document Specialist

    1 month ago


    Raritan, United States Proempire LLC Vitamatic Full time

    **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, file, and issue-controlled documents after a full review of analytical raw lab data...

  • Project Manager

    2 days ago


    Raritan, United States Sthree Full time

    Exciting 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 (1-3 days onsite/week depending on project need) Structure: Longterm contract...

  • SAP Project Manager

    2 weeks ago


    Raritan, United States Diverse Lynx Full time

    SAP Project Manager Raritan, NJ (Day 1 onsite) Job Description § A minimum of a Bachelor's degree § Expertise on managing SAP Migration projects as a Project manager § Sound knowledge on organizational IT Infrastructure and its architecture § Experience in IT Project/Program management for minimum 5 year § Strong knowledge on managing project finances....