Insmed is looking for a Sr. Quality Engineer, Digital Systems Quality Assurance (QA) to provide quality oversight of GxP computerized systems throughout their lifecycle, ensuring compliance with regulatory requirements and supporting the implementation and management of digital systems in GxP areas.
Requirements
- Strong understanding of GxP regulations (FDA, EMA, ICH) and applicable guidelines for computerized systems (21 CFR Part 11, Annex 11, GAMP 5).
- Hands-on experience with computer system validation (CSV) and lifecycle management in clinical and/or laboratory environments.
- Knowledge of clinical systems (e.g., EDC, IRT, eTMF, CTMS) and/or QC laboratory systems (e.g., LIMS, CDS, ELN, Empower) strongly preferred.
- Experience with On-premise/SaaS/cloud-hosted systems and supplier management, including supplier audits and qualification
- Understanding of data integrity principles and ALCOA+ requirements.
- Quality Professional Certificates such as ASQ Certified Software Quality Engineer, ASQ Certified Quality Engineer, ASQ Certified Quality Auditor, preferred.
- Working knowledge of all GxP regulations and guidances including 21 CFR Part 11, Annex 11, ICH Harmonized Guideline Good Clinical Practice (GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation, Quality Management Systems Processes
Responsibilities
- Provide Quality Assurance oversight for GxP computerized systems across their lifecycle (implementation, operation, maintenance, and retirement) to ensure compliance with FDA, ICH, and EU regulations.
- Review and approve computer system validation (CSV) deliverables (e.g., URS, FS, validation plans, protocols, reports, and test evidence).
- Ensure compliance with 21 CFR Part 11, Annex 11, data integrity, and electronic records/electronic signature requirements.
- Collaborate with IT System Owner, Business Owners, and validation teams to ensure risk-based approaches are applied in system qualification and validation.
- Perform QA review of change control, deviations, CAPAs, and periodic reviews for computerized systems.
- Support development, review, and approval of SOPs, work instructions, and procedural documents related to computerized system lifecycle management.
- Provide QA support during supplier qualification, audits, and system implementation projects, including SaaS/cloud-based solutions.
Other
- The Sr. Quality Engineer, Digital Systems Quality Assurance (QA), is responsible for providing quality oversight of GxP computerized systems throughout their lifecycle, ensuring compliance with FDA, EMA, and ICH regulatory requirements.
- This role will support implementation and ongoing management of digital systems used in clinical trial operations, quality control laboratories and other GxP areas, with a focus on data integrity, validation, and inspection readiness.
- The Sr. Quality Engineer will partner with IT, business, and vendor teams to apply risk-based approaches, maintain validated state, and drive continuous compliance in support of patient safety and product quality.
- Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related field preferred.
- 5+ years of experience in Quality Assurance, Validation, within the FDA-regulated pharmaceutical or biotech industry.
