Director, Quality Assurance Systems

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No.

1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role:

The Director of Digital Systems Quality Assurance (DSQA) is responsible for establishing, leading, and continuously improving the quality oversight of GxP digital systems supporting gene therapy manufacturing, pharmaceutical development, and analytical laboratories. This role ensures that computerized systems, data integrity controls, and digital workflows meet global regulatory requirements, internal quality standards, and lifecycle management expectations. This position will oversee and provide QA support for optimizing, troubleshooting, and maintaining key global and site GxP systems for Gene Therapy manufacturing, quality control, warehouse, and clinical programs;

including the NJ Research Development Location as necessary. The position will serve as the QA lead for Computer Software Validation lifecycle documents, site IT Change Control facilitation and QA review of CSV documents.

What You'll Do:

In this role, you will lead the implementation, validation, and lifecycle management of GxP digital systems within an FDA-regulated (or equivalent global regulatory) environment supporting Gene Therapy programs.

You'll also:

• Ensure deployed solutions are in alignment with business needs, in compliance with Data Integrity requirements

• Provide guidance to team members on software development life cycle, computer validation, and drive a risk-based approach methodology with all stakeholders.

• Provide oversight to the implementation and validation of GxP software applications/modules and associated interfaces according to business needs and internal procedures (support system upgrades, change control, retrospective validation, software add-on installations where capable).

• Work with project teams and business/quality representatives to ensure compliance with regulatory requirements such as FDA, EMEA, PMDA, CAPAs, GxP, etc

• Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents.

• Responsible for the local processes related to QMS, IT Change Control, Computerized System Validation, Data Integrity for electronic systems, and monitoring/auditing of audit trails.

• Provide support during regulatory inspections and internal audits.

• Experience with Veeva systems, Labware/Waters/Thermo Fisher software is preferred.

• Role-related knowledge:
  Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools.

• Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development, including delivery of multiple projects of various complexities

• Role-related knowledge:
  Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools.

Who You Are:

You have a minimum of 10 years of relevant Quality Assurance experience. An advanced degree (MS) and a minimum of 5 years relevant experience will also be considered

Additionally, you have:

• Education – BS Degree required or preferred

• Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc..

• Preferred experience in Data Integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile or Waterfall), CSA

• Must have excellent communication skills (verbal and written).

• Demonstrate ability to manage projects and variable workloads.

• Highly…