Lead the strategic and technical oversight of Quality Control (QC) activities for biologics and combination device products across their lifecycle
Job Summary
Lead the strategic and technical oversight of Quality Control (QC) activities for biologics and combination device products across their lifecycle.
Ensure success of the Quality Control function through strategic and scientific leadership, developing strong collaborative relationships with internal and external teams.
Collaborate with internal cross-functional CMC/Quality teams and Regulatory Affairs to support control systems, quality management, and regulatory submissions.
Matching Summary
Lead the strategic and technical oversight of Quality Control (QC) activities for biologics and combination device products across their lifecycle.
Salary
Base: $188,200 - $282,400; Bonus/Equity: Eligible for annual bonus and equity awards; Benefits: Market-leading benefits including medical, dental, vision, PTO, educational assistance, 401(k)
Skills & Requirements
Must-have
QC strategies for biologics
cGMP regulations
External testing site oversight
Analytical data analysis
Regulatory submission support
Nice-to-have
Digital quality system maturity
Cross-functional collaboration
Calm decision-making under uncertainty
Key Requirements
M.S. or Ph.D. degree with 12+ years industry experience
12+ years in analytical development/quality control
Extensive experience in biologics characterization
Extensive knowledge of regulatory requirements (ICH, FDA)