Sr. Manager Digital Systems Assurance CSV
Insmed Incorporated

Overview

This position is primarily responsible for supporting and providing oversight to Validation and Life Cycle Management activities for GxP Computer Systems used to support the end-end GxP Supply chain including the Quality Management System, manufacturing, quality control, warehouse, and clinical operations. The position will provide end users guidance and support complex issues on Computer Systems utilized to support quality management system activities. The position will serve primarily as the QA for regulated computer systems, provide guidance and risk based compliant solutions to business/system owners for Computer Software Validation lifecycle management documents and Quality Systems documents/records such as Policies, Procedures, IT Change Control, Deviations, CAPA, Supplier Qualification, Periodic Reviews etc. The position is expected to work independently with limited supervision and apply critical thinking.

Responsibilities

Responsibilities (Essential RoleResponsibilities):
Additional responsibilities will include, but not necessarily be limited to, the following:

• Represent Digital Systems QA as a GxP computer system validation expert and provide oversight and guidance on computer systems validation in accordance with applicable regulations, guidelines, policies and procedures . This includes the application of risk-based approaches to computer system validation.
• Support Computer System Life Cycle Management activities such as System Changes , Upgrades , Periodic Reviews, Audit Trail Review , Incidents as Digital System QA.
• Train, support and advise end users on GxP Computer System validation practices and EDMS / QMS system requirements and workflows.
• Lead GxP IT Change Control cross functional subject matter expert forum assessing GxP Computer System changes to be implemented for continuous improvement.
• Writes SOPs and other quality system documentation, assists other departments with the generation, review , approval and maintenance of such documents.
• Provide support during regulatory inspections , internal audits and supplier qualifications .
• Experience with Veeva systems is preferred.
• Experience implementing, validating , and maintaining, GxP Computer Systems in validated state in an FDA or equivalent regulated settings.
• Role-related knowledge: Working knowledge of all GxP regulations and guidances including 21 CFR Part 11, Annex 11, ICH Harmonized Guideline Good Clinical Practice (GCP) E6(R3) , C omputerized Systems Used in Clinical Trials , Computer System Validation , Q uality Management S ystems, and quality management tools.

Position Requirements (Required and/or Preferred Skills, Experience and Education):

• Education - BS Degree required or preferred.
• A minimum of 8 years of relevant Quality Assurance experience required . An advanced degree (MS) and a minimum of 5 years relevant experience will also be considered.
• Experience in working in a GxP regulated industry and preferably in quality assurance role.
• Experience as QA reviewer of several GxP records and processes : Change Controls, Computer System Validation Deliverables , Deviations, CAPA, SOPs, etc. .
• Must be familiar with 21 CFR Part 11 , Annex 11 , GAMP 5, Data Integrity and SDLC (Agile or Waterfall) and applying risk-based approaches .
• Quality Professional Certificates such as ASQ Certified Software Quality Engineer, ASQ Certified Quality Engineer, ASQ Certified Quality Auditor, preferred .
• Must have excellent communication skills (verbal and written).
• Demonstrate ability to manage projects and variable workloads.
• High ly organized with a strong attention to details , clarity, accuracy, and conciseness.
• M ust successfully exhibit Insmed's five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies

Supervision of Others: This is a non-supervisory position . Travel: Up to 1 0% travel

Salary Range

Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.

The base salary range for this job is from $111,000.00 to $156,133.00 per year

This job has expired.