Associate Director, Technical Operations Quality Control

Position Summary The Associate Director, Technical Operations QC is responsible for managing Quality Control activities in compliance with GMP and international regulatory standards. Provides technical leadership and scientific decision‑making for QC control strategies, with extensive knowledge of FDA, ICH, and EU regulatory requirements; able to work effectively in a virtual environment. Responsibilities Coordinate and lead QC activities for drug substance and drug product manufacturing. Oversee specification development, batch release, and stability programs at CMOs. Provide scientific/technical support to internal and external groups to ensure products are tested and released per applicable regulations. Provide QC oversight of stability (forced degradation, photostability) from protocol design through data review, trend analysis, and stability reports for shelf‑life. Support method transfer with Analytical Development. Support regulatory submissions/variations with Regulatory CMC. Support comparability assessments for process changes. Guide vendor work during OOS/OOT/atypical results/deviations; ensure scientifically sound, risk‑based reports and appropriate CAPAs. Serve as SME for QA PAI readiness and vendor audits. Education and Experience Requirements Bachelor’s in Chemistry/Biochemistry/related Life Sciences (Master’s preferred). 8+ years in analytical operations/development or QC of biologics (late‑stage preferred). Direct knowledge of dissolution and analytical methods (HPLC, GC, MS, NMR, IR, UV, etc.). Broad GMP and regulatory affairs knowledge. Additional Skills Courage, Community, Patient Focus, Teamwork. Adaptability; strong interpersonal/organizational skills; independent and team work. Strong written/verbal communication; decision‑making and attention to detail. Manage multiple priorities in fast‑paced environment. Veeva/Quality Doc a plus. Travel 10–20%. Onsite/face‑to‑face in San Diego essential; not 100% remote. Total Rewards & Benefits Premium health, financial, work‑life/well‑being; wellness programs; life insurance; disability; retirement match; generous paid time off. #J-18808-Ljbffr Scorpion Therapeutics