Senior Quality Specialist (Document Control and Record Management

Senior Quality Specialist, Quality Systems

Reporting to the Associate Director, Quality Systems, Document Control, the Senior Quality Specialist, Quality Systems will play a key role in supporting QA and Regulatory Compliance activities for Insmed. You will support the Global Document Control and Records Management programs within the Quality Management System (QMS) at Insmed, ensuring documentation and systems supporting GxP operations meet global regulatory requirements, internal quality standards, and lifecycle management expectations.

In coordination with the Associate Director, Quality Systems, Document Control, primary areas of responsibility include monitoring, reviewing, and approving Quality Documents in the electronic QMS, managing and administering the Document Control System, supporting the New Jersey Site Physical Record Archive Room, generating Quality System Metrics, and owning and authoring related SOPs for these systems. Partnering with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, and other cross-functional stakeholders, you will ensure documentation practices enable compliant operations and consistent quality standards.

In this role, you'll have the opportunity to support processes within the QMS Document Control and Records Management System including process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations for the specified QMS process. You'll also:

• Maintain all activities to support Document Change Control process, including supporting controlled document life cycle, document change requests, classification, and periodic review.
• Support Global Records Management Program and supports on-site GxP Archive Room which includes archiving and storing of records, coordinating off-site storage, managing periodic record reconciliation, and assessing document retention against Global requirements.
• Review all Standard Operating Procedures (SOPs), forms, templates, reports, standard test methods and specifications, and technical documents, as applicable, ensuring all documents are maintained to latest revisions and format.
• Track all Document Change Controls for completeness, timely reviews, approvals, and closure.
• Ensure Data Integrity requirements as it pertains to Electronic/Digital Signatures and Document and Records Management are upheld.
• Report and trend on all open Quality Documents.
• Handle compilation of quality metrics for monthly trending, management review meetings and follow up for the closure of process improvements. Presentation and communication of trending reports in respective Quality forums.
• Train QA and stakeholders in QMS processes.
• Review and update SOPs, policies, and standards regularly to ensure compliance with GxP standards, FDA/EMA/ICH and other applicable competent authority regulations and requirements. Participate in meetings to support colleagues in Global time zones (EMEA, APAC, California).

You have a minimum of a BS degree in Chemistry, Life Science or related discipline preferred along with 3+ years of relevant Quality Assurance experience within pharma/biotech industry.

You are or you have:

• Direct experience with Document Control management in pharmaceutical or medical device products.
• Full understanding of cGMPs for pharmaceutical products. Familiarity with other GxPs (GCP, GVP, GDP, GLP).
• Experience with Health Authority inspections and/or internal audits preferred.
• Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
• Experience working with an electronic document management system (EDMS).
• Working knowledge of the Change Management System and understanding of thorough business impact assessments.
• Understand CSV process and deliverables. Prior experience writing and executing UAT/PQ scripts, risk assessments, and performing audit trail reviews preferred.
• Experience at reviewing procedural documents.
• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals and/or ISO 14971.
• Understanding of risk-based decisions consistent with ICH Q9 principles.

This is a hybrid role based out of…