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Senior Manager, QC

5 days, 14 hours ago
United States
Full-time
Senior
QA Engineer
Quality Assurance and Testing
Statistics
Apply Now
Immunovant

Immunovant

Pharmaceuticals
51-250
Founded 2018
$725M raised
View All Jobs 2

Description

  • Oversee GMP testing at CMOs and third-party testing sites for raw materials, components, in-process materials, and drug substance.
  • Review analytical source data and quality documentation to ensure data integrity, traceability, and product release compliance.
  • Ensure phase-appropriate qualification and validation of QC analytical methods in collaboration with Analytical Development.
  • Manage technology transfers and method improvements to support reliable, fit-for-purpose, cGMP-compliant methods at testing laboratories.
  • Provide oversight and leadership for OOS investigations, change controls, deviations, CAPAs, risk assessments, and continuous improvement initiatives.
  • Review and approve sampling instructions, test methods, specifications, stability protocols, and other QC procedures.
  • Drive product quality through virtual QC systems and supplier oversight.
  • Maintain laboratory quality processes in compliance with GMP, company policies, and procedures.
  • Monitor emerging quality and regulatory requirements and work to remediate identified gaps.
  • Support regulatory inspections and third-party audits for contracted testing laboratories.

Requirements

  • Bachelor’s degree in Biology, Chemistry, or a related field with 6 years of experience in biopharmaceutical analytical and/or QC operations, or a master’s degree with 5 years, or a PhD with 4 years.
  • Experience working with monoclonal antibody products is desirable.
  • Demonstrated experience managing third-party laboratories.
  • Strong understanding of global analytical GMP regulations, including FDA, EMA, and ROW requirements.
  • Knowledge of proteins and/or mAbs separations and multiple HPLC/capillary electrophoresis modes such as SEC, RP-HPLC/UPLC, IEX, icIEF, and CE-SDS.
  • Experience with ProteinSimple Maurice iCIEF and CE-SDS systems is desired.
  • Knowledge of ELISAs, binding assays, impurity assays, host cell protein detection, residual impurity testing, and peptide mapping is preferred.
  • Experience in analytical and/or microbiology method transfer and validation following ICH guidelines is desired.
  • Experience with reference standard management is required.
  • Strong GMP quality systems experience, including document control, deviations/complaints, change control, DS/DP product release, and CAPAs with CMO partners.
  • Ability to independently resolve technical issues and lead internal and external SMEs on complex problems.
  • Ability to manage multiple competing priorities in a fast-paced environment.
  • Strong analytical, organizational, written, verbal, listening, and interpersonal communication skills.
  • Knowledge of statistics, including JMP software, is desirable.
  • Experience with MS Office, Veeva Quality Docs, Empower, and LIMS is required.

Benefits

  • Salary range of $165,000 to $185,000 USD.
  • Equity and other forms of compensation may be provided as part of the total package.
  • Full medical, dental, and vision coverage.
  • 401(k) benefits.
  • Unlimited paid time off.
  • Parental leave.
  • Remote-based work with access to Immunovant’s NYC and NC locations.
  • Domestic travel up to 15%.

Interested in this position?

Apply directly on the company website

Apply Now

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