Senior Manager, QC

Key Responsibilities

• Oversee GMP testing at CMOs/ third party testing sites as it applies to Quality Control testing of raw materials, components, in-process, and drug substance.
• Verify/review analytical source data to ensure data integrity, traceability, and compliance during review of all analytical documentation required for the release of product.
• Ensure adequate phase-specific qualification and validation of analytical QC test methods in collaboration with Analytical Development, through oversight and collaboration, and data/document review of associated protocols/reports.
• Manage technology transfers and method improvements needed to ensure reliable, robust, fit for purpose, and cGMP compliant methods are implemented at the testing laboratories.
• Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory requirements.
• Provide analytical oversight, facilitation, 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 Quality Control procedures.
• Drive product quality through effective virtual QC systems, provide supplier oversight with adequate surveillance.
• Assure all applicable laboratory quality processes are deployed within IMVT and maintained in accordance with GMP, policies, and procedures.
• Monitor and assess emerging Quality and Regulatory requirements/issues and determine impact to Immunovant and work to remediate any identified gaps.
• Ensure contracted third-party testing laboratories follow appropriate quality and regulatory practices and participate in regulatory inspections and third-party audits, as needed.
• Encourage an environment for 'Quality Right First Time' by building in efficiencies as necessary from a systematic and compliance perspective.

Requirements

• Bachelor (B.S.) or advanced degree in Biology, Chemistry, or related fields and 6 years (or MS with 5 years, PhD with 4 years) of experience in biopharmaceutical analytical and/or QC operations.
• Experience working with monoclonal antibody products is desirable.
• Demonstrated experience effectively managing third party laboratories.
• Strong understanding of analytical GMP regulations governed by global health authority markets including FDA, EMA, and ROW.
• Knowledge of proteins and/or mAbs separations such as multiple modes for HPLC and capillary electrophoresis (e.g., SEC, RP-HPLC/UPLC, IEX, icIEF, CE-SDS).
• Protein Simple Maurice iCIEF and CE-SDS systems is desired.
• Knowledge of other analytical methodologies such ELISAs and other binding assays, impurity assays such as detection of host cell proteins, residual impurities, and peptide-mapping based on project needs, is preferred.
• Experience in qualification of analytical / microbiology method transfer and validation following ICH guidelines is desired.
• Experience with reference standard management is a plus.
• Ability to independently resolve technical issues; effectively lead teams with internal and external SMEs to solve issues with broad scope and/or high complexity.
• Strong knowledge, understanding and experience working in GMP-regulated quality environments and systems (e.g., document control, deviations/complaints, change control, DS/DP product release, CAPAs) with CMO partners.
• Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment.
• Ability to take initiative, prioritize and execute tasks with minimal direction or supervision, maintaining a high-level of integrity.
• Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants).
• Strong analytical and organizational skills, with attention to detail.
• Excellent written, verbal, listening and interpersonal communication skills.
• Knowledge of statistics including the use of JMP software.
• MS Office applications, Veeva Quality Docs, Empower, LIMS, is Work Environment