Job Title: Senior Manager / Associate Director, Manufacturing Quality Operations
Position Summary
The Senior Manager / Associate Director, Manufacturing Quality Operations leads the QA On-the-Floor (OTF) team, providing real-time quality oversight of clinical and commercial manufacturing activities within a cGMP environment. This role is responsible for ensuring compliance, driving quality execution on the manufacturing floor, and maintaining a sustained state of control through close cross-functional collaboration.
This opportunity is with a Phase III-stage company approximately one year from BLA submission, offering the chance to play a critical role in bringing an innovative gene therapy to market during a pivotal stage of growth and regulatory advancement.
Key Responsibilities
Team Leadership & Oversight
- Lead, coach, and develop the QA OTF team, including performance management and training compliance
- Assign and prioritize daily activities, ensuring adequate staffing to support manufacturing schedules
- Maintain team readiness for aseptic, gowning, and GMP requirements
Manufacturing Quality Oversight
- Ensure consistent QA presence on the production floor through walkthroughs and direct observation
- Oversee real-time batch record review for accuracy, completeness, and compliance
- Identify, document, and escalate GMP issues and compliance risks
Quality Decision Making & Issue Resolution
- Make QA decisions related to room/equipment release, line clearance, and documentation
- Review and approve deviations, change controls, and other quality records
- Partner cross-functionally to investigate issues, perform root cause analysis, and implement CAPAs
Documentation & Compliance
- Ensure timely review of GMP documentation (batch records, logbooks, forms, etc.)
- Author and revise SOPs and quality procedures
- Support audits, inspections, and regulatory readiness activities
Cross-Functional Collaboration
- Partner with Manufacturing, QC, Supply Chain, and Facilities to align quality and operational goals
- Participate in continuous improvement and manufacturing readiness initiatives
- Serve as a subject matter expert for QA OTF activities
Qualifications
- Bachelor’s degree in a scientific discipline or equivalent experience
- 8+ years of QA experience in a GMP-regulated environment
- 3+ years of leadership or people management experience
- Experience supporting aseptic manufacturing operations strongly preferred
Skills & Knowledge
- Strong knowledge of GMP regulations (FDA, EU, ICH) and quality systems
- Ability to resolve complex quality issues and make sound decisions
- Excellent communication, leadership, and documentation skills
Work Environment
- Full-time onsite role in a cGMP manufacturing facility
- Requires gowning and extended time in cleanroom environments
- Ability to stand for extended periods and perform physical tasks as needed
