4 Quality Compliance Manager Jobs in Raritan, NJ
Legend Biotech is Hiring a Quality Compliance Manager Near Raritan, NJ
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
Key Responsibilities
- Successfully support the implementation, execution, and improvement of the internal audit process.
- Support the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit reports, issue audit observations and follow-through to ensure satisfactory resolution and closure of each internal audit.
- Coordinate front room/ back room activities for health authority audits and independent audits; manage audit responses and observation resolution.
- Drive site compliance to regulatory, enterprise, and global requirements through building positive relationships across functions, to meet unified business objectives.
- As required, run reports and conduct data analysis to support monitoring of key performance indicators; support the preparation of compliance data for the monthly CRB & quarterly QSMR presentations.
- Fulfills the Quality System audit module site key user responsibilities - represent the Raritan site in global forums/ team meetings, mentor site users for audit process, and control access to any systems used to support audits/inspections.
- Provide support to quality systems team, ad hoc, for activities such as annual product review, site risk register, or internal quality agreements.
- Develops and delivers training for specific quality system topics, in both classroom setting and individual interactions
- Support the creation, assessment and closure as needed of corrective actions, change controls, or audit actions related to the site
- Ensures and maintains a state of inspection readiness.
- Perform compliance walkthroughs as part of audit/inspection readiness activities to ensure that the site is an inspection ready state.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required
- A minimum of six (6) years of experience in Quality Assurance/ Quality Systems or Compliance
- Experience conducting internal audits (self-inspection), including writing audit reports, writing observations, and follow-through of observation resolution
- Experience in front room/ back room roles for external audits
- Experience working with quality systems is required
- People leader experience preferred
Legend Biotech maintains a drug-free workplace.
Benefits:
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Matched 401K
- Flexible Spending Account
- Health Savings Account
- AD&D Insurance
- Short-Term Disability
- Long-Term Disability
- Paid Maternity Leave
- Paid Paternity Leave
- Pet Insurance
- Critical Illness Insurance
- Hospital Indemnity Insurance
- Accident Insurance
- Legal Insurance
- Commuter Benefits
- Employee Assistance Program
Job Summary
Full Time
Scientific Services
$130k-168k (estimate)
01/09/2025
03/07/2025
legendbiotech.com
PISCATAWAY, NJ
500 - 1,000
2014
YING HUANG
$50M - $200M
Scientific Services
Related Companies
About Legend Biotech
From the very beginning, weve been focused on the science. We came together as a team of experts, committed to quality, driven by excellence, and dedicated to experimentation. Though we faced many challenges, we remained fearless in our research and rigorous in our thinking, pushing ourselves to work harder. But what impacted us the most was the enormous burden patients bear and the difficulties they face, which drove us to think about whats next. We believe its time to accelerate and expand that transformation. At Legend Biotech, we are excited to bring clinical trials to patients in our purs...uit of a cure. While we are focused on CAR-T in multiple myeloma, we firmly believe the prospects of cellular therapy stretch beyond just one disease or indication. The spark of hope is lit. At Legend Biotech, we're using that hope to ignite the future of CAR-T cell therapy.
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The job skills required for Quality Compliance Manager include Regulatory Compliance, Internal Audit, Collaboration, Quality Assurance, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Compliance Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Compliance Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Compliance Manager positions, which can be used as a reference in future career path planning. As a Quality Compliance Manager, it can be promoted into senior positions as a Compliance Manager, Senior that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Compliance Manager. You can explore the career advancement for a Quality Compliance Manager below and select your interested title to get hiring information.
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