Senior Scientist, Laboratory QA
Immunovant
Senior Director, Commercial GMP Quality
MDWerks Inc.
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Lead the development and execution of the Commercial GMP Quality strategy aligned with corporate objectives and regulatory expectations
- Serve as the primary GMP Quality leader for commercial manufacturing activities, providing direction and oversight for internal teams and external partners
- Partner with cross-functional leadership to support product launches, tech transfers, and lifecycle management initiatives
- Oversee design, implementation, and governance of GMP Quality Systems (deviations, CAPAs, change control, batch record review, product disposition, quality metrics)
- Ensure continued inspection readiness across all GMP operations with proactive risk management and mitigation strategies
- Provide final Quality review and disposition of commercial drug product and drug substance, ensuring timely release
- Ensure compliant and efficient review of master and executed batch records, including investigation resolution and traceability documentation
- Serve as the senior quality representative for GMP contract manufacturers (CMOs), testing labs, and other service providers
- Oversee quality agreements, external audits, and performance monitoring for third-party vendors
- Lead GMP-related inspections and audits (FDA, EMA), manage responses and follow-up actions
- Direct internal and external audit programs, risk-based audit planning, execution, and CAPA closure
- Foster a proactive quality culture focused on continuous improvement, right-first-time execution, and operational excellence
- Leverage data and quality metrics to drive decision-making and promote transparency with senior leadership
- Position requires up to 25% travel, including occasional international trips
Requirements
- Bachelor’s degree in life sciences, chemistry, or related discipline required
- Ph.D. or advanced degree preferred
- Minimum 15 years of experience in GMP Quality Assurance roles within the pharmaceutical or biotech industry, including at least 5 years in a senior leadership capacity
- Extensive experience in commercial manufacturing, product release, regulatory inspections, and third-party quality oversight
- Strong knowledge of global GMP regulations and industry best practices
- Flexibility to adapt to a fast-changing, ambiguous environment in an organization without fully established procedures
- Velocity, Data-Driven Decision Making, Agile Mindset, Frictionless Execution, Autonomy, and Execution that Delivers Value attributes
- Up to 25% travel, including frequent overnight and some international travel
