Senior Manager, Development Quality Assurance

About the Role

Reporting to a Director of Clinical Quality Assurance, the Sr. Manager of Clinical Quality Assurance serves as a Development QA (DevQA) representative on the development team assuring quality and regulatory compliance related to GCPs and other related activities performed by Clinical Study (Trial) Teams. You will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations, and guidelines.

What You'll Do

• Serve and maintain qualification as a GCP Subject Matter Expert (SME) and contribute to and support the maintenance of a risk-based and scientific-based quality system to support GCP
• Ensure that a strategic audit plan is implemented and activities are conducted and reported according to SOPs and regulations
• Perform audits of investigator sites, TMFs, vendors, and internal systems/processes
• Support the evaluation and acceptability of clinical vendors/suppliers
• Support strategic direction with cross functional working groups to identify and mitigate GCP quality and compliance issues
• Establish and foster compliance with ICH E6 Guideline for Good Clinical Practice
• Provide support and coaching to other staff members to develop additional quality and auditing resources
• Manage quality documentation in Veeva QMS
• Act as company's representative during regulatory agency inspections

Basic Qualifications

BA/BS degree in Biology or Chemistry or related life sciences discipline along with a minimum of 5 years of GCP experience.

Preferred Qualifications

• Understanding and practical working knowledge of clinical regulations, good clinical practices, development processes, and regulatory inspection procedures
• Experience in developing SOPs, reviewing internal clinical, regulatory, and medical processes to ensure they are consistent with current regulatory and GCP requirements
• GCP audit experience with the ability to conduct external audits of investigator sites, CROs, supporting laboratories, and monitoring organizations with responsibility for writing audit reports and reviewing and tracking CAPAs
• Experience in supporting regulatory agency inspections and working with regulators and internal staff to help prepare for inspections
• Broad knowledge of risk-based quality systems and approaches consistent with ICH E6 for Good Clinical Practice
• Solid experience with Phases I-IV (particularly Phase III); experience with Regulatory approval, NDAs and MAAs is preferred
• Ability to foster a collaborative/partnership environment, adapt to other personalities in a respectful manner that is conducive to goal achievement and team building while maintaining quality and compliance
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness

Where You'll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.

Travel Requirements

This position involves frequent domestic/international travel (up to 25-30%) to support clinical QA including external audits.