Senior Director, QC Laboratory
$258,000–$285,000 year
HybridNeedham, Massachusetts, United States
Job Summary
Establish and lead the internal GMP Quality Control laboratory, defining operations, workflows, and execution standards. Directly manage QC staff to foster a compliant team culture while ensuring all activities meet GMP requirements, internal SOPs, and data integrity expectations. Serve as a key partner to Quality Assurance for deviations, investigations, change controls, CAPAs, and inspection readiness, collaborating cross-functionally with R&D, Manufacturing, and Regulatory Affairs to support testing needs and program timelines. Drive continuous improvement initiatives, implement scalable QC processes, and lead staffing plans including onboarding, training, and succession planning. Support audit and inspection activities related to laboratory operations and documentation.
Required Qualifications
- Bachelor's degree in a scientific discipline
- Minimum of 10 years of experience in a GMP Quality Control laboratory environment within biotech or pharmaceutical organizations
- Demonstrated experience operating within a true QC organization, with a strong understanding of QC structure, controls, and GMP rigor
- Prior experience leading, mentoring, or managing QC laboratory staff
- Experience supporting GMP inspections, audits, and quality system activities impacting QC operations
- Strong interpersonal, leadership, and communication skills with the ability to partner effectively across functions
- Must be authorized to work in US
- Must be available for hybrid work in Needham, MA office (2-3 days a week)
Desired Qualifications
- Advanced degree
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.