Assistant Director/Associate Director, GMP Quality – Drug Substance - Carlsbad
2 weeks ago
Job Summary
+Ionis is seeking an experienced Assistant Director/Associate Director, GMP Quality – Drug Substance to lead and oversee Quality Assurance activities supporting both clinical and commercial Drug Substance (DS) manufacturing and testing.
+
Responsibilities
+- Lead and manage GMP Quality Assurance activities supporting internal and external Drug Substance and Intermediate manufacturing,
- May manage mentor develop QA staff ,
- Provide QA oversight across clinical commercial programs ensuring phase-appropriate compliance inspection readiness Drive continuous improvement initiatives enhance compliance efficiency product quality Collaborate cross-functionally Technical Operations CMC Regulatory Clinical Supply Chain teams Communicate quality supply-impacting issues clearly internal external stakeholders Oversee execute core Quality Management System QMS processes batch record review deviations investigations CAPAs change control OOS/OOT management risk management validation training compliance Review approve technical quality documentation including validation reports stability data APQR/QMR inputs Serve primary QA interface contract manufacturing testing organizations CMOs including review approval manufacturing documentation analytical data deviations changes validation packages Participate real-time QA decision-making critical manufacturing operations Support lead regulatory inspections partner audits Qualified Person QP interactions General ResponsibilitiesSupport new quality initiatives cross-functional projects Apply cGMP knowledge daily activities Perform additional duties assigned Education ExperienceBachelor degree Chemistry Biological Sciences Engineering related discipline advanced degree preferred 10–12+ years pharmaceutical industry experience including 7–8+ years in Quality Assurance within cGMP environment Demonstrated experience supporting Drug Substance manufacturing across clinical commercial stages Technical Professional SkillsStrong knowledge global cGMP regulations FDA EMA ICH etc Experience SAP Veeva systems highly desired Strong analytical technical critical-thinking skills experience in manufacturing excellent written verbal communication skills Ability manage multiple priorities adapt changing business needs Please visit our website Ionis apply position reference requisition #IONIS003877Ionis offers excellent benefits package Follow link more details:
Job description
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