Yoh Life Sciences is looking for a Quality Sr. Manager, Gene Therapy for a large pharmaceutical client in the Boston area!
General position summary:
The Senior Manager is responsible for support and quality oversight for the assigned programs focused on Gene Therapy/ Biologics and possesses a strong knowledge of GCP study oversight and management of quality activities related to clinical trial execution and GMP cell-based production (drug development).
The Senior Manager is knowledgeable in the principles and application of quality and regulatory compliance with significant knowledge of regulations applicable to Gene Therapy across the GCP/GMP areas.
Position may require up to 10% national/international travel.
The responsibilities of this position may include, but are not limited to, the following:
- Provide strategic GCP quality compliance, oversight, and consultation supporting the Gene Therapy program
- Provide regulatory compliance support & guidance to cross functional study teams
- Ensure compliance with study protocol and study related procedures/ processes
- GCP review and approval of applicable procedures (internal, external business partners and vendors)
- Drive investigations to closure, facilitating root cause analysis and the development of effective CAPA plans
- Participate in protocol deviation reviews
- Support deployment of Quality Management System
- Risk identification and communication
- May participate on process improvement initiatives
- Identify and perform KPI/ Metric analysis
- Engage in preparation, support and follow-up activities related to Inspection Readiness
- Review changes to applicable global regulations/ guidances and participate on cross functional team to assess impact to Quality Management System
- Provide cross-functional support across QA as needed (e.g., Vendor Oversight, Audit and Inspection Management, etc.)
- Master’s degree and 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 5-8 years of relevant work experience, or relevant comparable background
- Experience/knowledge of biologics and/or gene therapy regulations and products
- ICH E6 (R2), 21 CFR Part 50, 54, 56, 312, 314, and high level knowledge of 21 CFR Part 11 and International equivalents as necessary; best practices and industry standards
- In-depth Gene Therapy Quality experience across GCP and GMP areas
- Event Management process and requirements, including CAPA and Effectiveness Checks
- Root Cause Analysis and Investigation process, tools, and techniques
- Risk management principles and process, change management
- Ability to provide GCP compliance interpretation, consultation, training and other supportive services to study execution team
- Adaptability/ flexibility
- Analytical thinking/ Data Analysis
- Attention to detail
- Communication, presentation and facilitation skills across all organizational levels
- Strategic/ critical thinking, risk based decision making and problem solving skills