Director, QA for QC
Intellia Therapeutics, Inc.
August 26, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities:
- Provide strategic and operational quality oversight of Quality Control (QC) activities supporting development, manufacture, testing, release, and lifecycle management of gene editing products.
- Provide technical leadership for analytical control strategies, method performance, reference standards, specifications, and laboratory investigations.
- Ensure QC activities are executed in compliance with global GMP regulations and internal Quality Systems; govern QC compliance, analytical control strategy, investigation oversight, stability programs, reference standards, and test method governance.
- Provide quality oversight of outsourced testing operations; act as primary QC quality escalation for critical issues using risk-based judgment.
- Establish and lead data-driven trending using stability, release, and routine testing data; integrate trend outputs into QRM pathways.
- Oversee External Laboratory Investigations (OOS/OOT/atypical/deviations/data integrity) to ensure sound, risk-based investigations with effective CAPAs.
- Lead lifecycle management for reference standards and critical reagents; support stability program lifecycle management (protocol input/approval, oversight, review, reporting).
- Oversee specification management and analytical method validation/verification/lifecycle management/method transfers.
- Partner with Regulatory Affairs; lead/support QA audits and regulatory inspections of QC labs as a QC analytical control strategy SME.
- Mentor and coach QC/QA personnel; drive continuous improvement and QC metrics contributions to QMR.
Supervisory Responsibilities:
- Recruit, interview, hire, train, evaluate, and manage QC QA staff; oversee daily workflow and mentor team.
Qualifications:
- Prior direct/indirect experience overseeing employees.
- Knowledge of FDA/ICH guidance and USP/NF, EP, JP; experience with EDMS/LIMS.
- Stability program experience; generation of in-house reference standards.
- Data analysis tools (e.g., JMP, MINITAB, GraphPad Prism, PLA).
- Detail oriented; strong communication, delegation, organization, and analytical/problem-solving skills.
- Technical understanding of analytical techniques (HPLC/UPLC, CE, compendial, UV, bioassay, gel electrophoresis).
- Advanced degree (MS/PhD preferred) in relevant scientific field; 10–12 years relevant industry experience.
- Experience with phase-appropriate GMP testing and lab operations for cell/gene therapies or biologics.
- Expertise in qualification/validation/transfer and analytical method lifecycle management.
- Experience with health authority inspections and CAPA implementation.
- Experience filing IND/BLA for ATMP/biologic products; commercial QC activities.
Application:
- Applications accepted on a rolling basis until the position is filled.
- Provide strategic and operational quality oversight of Quality Control (QC) activities supporting development, manufacture, testing, release, and lifecycle management of gene editing products.
- Provide technical leadership for analytical control strategies, method performance, reference standards, specifications, and laboratory investigations.
- Ensure QC activities are executed in compliance with global GMP regulations and internal Quality Systems; govern QC compliance, analytical control strategy, investigation oversight, stability programs, reference standards, and test method governance.
- Provide quality oversight of outsourced testing operations; act as primary QC quality escalation for critical issues using risk-based judgment.
- Establish and lead data-driven trending using stability, release, and routine testing data; integrate trend outputs into QRM pathways.
- Oversee External Laboratory Investigations (OOS/OOT/atypical/deviations/data integrity) to ensure sound, risk-based investigations with effective CAPAs.
- Lead lifecycle management for reference standards and critical reagents; support stability program lifecycle management (protocol input/approval, oversight, review, reporting).
- Oversee specification management and analytical method validation/verification/lifecycle management/method transfers.
- Partner with Regulatory Affairs; lead/support QA audits and regulatory inspections of QC labs as a QC analytical control strategy SME.
- Mentor and coach QC/QA personnel; drive continuous improvement and QC metrics contributions to QMR.
Supervisory Responsibilities:
- Recruit, interview, hire, train, evaluate, and manage QC QA staff; oversee daily workflow and mentor team.
Qualifications:
- Prior direct/indirect experience overseeing employees.
- Knowledge of FDA/ICH guidance and USP/NF, EP, JP; experience with EDMS/LIMS.
- Stability program experience; generation of in-house reference standards.
- Data analysis tools (e.g., JMP, MINITAB, GraphPad Prism, PLA).
- Detail oriented; strong communication, delegation, organization, and analytical/problem-solving skills.
- Technical understanding of analytical techniques (HPLC/UPLC, CE, compendial, UV, bioassay, gel electrophoresis).
- Advanced degree (MS/PhD preferred) in relevant scientific field; 10–12 years relevant industry experience.
- Experience with phase-appropriate GMP testing and lab operations for cell/gene therapies or biologics.
- Expertise in qualification/validation/transfer and analytical method lifecycle management.
- Experience with health authority inspections and CAPA implementation.
- Experience filing IND/BLA for ATMP/biologic products; commercial QC activities.
Application:
- Applications accepted on a rolling basis until the position is filled.