Senior Director, Quality Control
Core
Provide strategic, scientific, and operational leadership for the end-to-end Quality Control (QC) function in a biotechnology company developing RNA medicines.
Role type
Senior Director, Quality Control (Strategic & Operational Leadership)
Builds
Antisense oligonucleotide (ASO) therapeutics for central nervous system and eye diseases
Domain
Biotechnology / RNA Medicine / Analytical Sciences
Required skills
Analytical method lifecycle management, GMP compliance, regulatory filing preparation, analytical control strategy development, CMO/CTL oversight, risk-based quality management, team leadership
Preferred skills
Experience with oligonucleotide products, cross-functional collaboration, inspection readiness
Technologies
None explicitly listed
Responsibilities
Establish and lead global QC strategy for all stages of product development; oversee lifecycle management of analytical methods including validation and stability testing; lead selection and governance of Contract Testing Laboratories (CTLs); provide technical input into regulatory submissions (IND, NDA); support GMP inspection preparation; mentor and develop a team of QC professionals
Seniority
Senior Director, strategic leadership with hands-on technical contribution
