Director, Quality Assurance Systems

Responsibilities
- Establish, lead, and continuously improve quality oversight for GxP digital systems supporting gene therapy manufacturing, pharmaceutical development, and analytical laboratories.
- Ensure computerized systems, data integrity controls, and digital workflows meet global regulatory and internal standards throughout lifecycle management.
- Oversee QA support for optimizing, troubleshooting, and maintaining global/site GxP systems (gene therapy manufacturing, QC, warehouse, and clinical programs), including NJ as needed.
- Serve as QA lead for Computer Software Validation (CSV) lifecycle documentation; facilitate site IT Change Control; QA review of CSV documents.
- Lead implementation, validation, and lifecycle management of GxP digital systems in an FDA-regulated (or equivalent) environment.
- Ensure alignment with business needs and Data Integrity requirements; guide risk-based, SDLC/computer validation approaches.
- Provide regulatory/audit support; write and support SOPs/quality documentation.

Qualifications & Preferred Skills
- Minimum 10 years QA experience (MS + 5 years relevant experience considered).
- BS degree required/preferred.
- QA reviewer experience for GMP records/processes (CSV validation protocols, deviations, CAPA, SOPs).
- Preferred: Data Integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile/Waterfall), CSA.
- Preferred: Veeva; Labware/Waters/Thermo Fisher software.
- Excellent verbal/written communication; strong organization and attention to detail; manage projects/variable workloads.

Travel: up to 30%.

Application (internal): Current Insmed employees apply via the Jobs Hub in Workday.