Associate Director, Quality Assurance

Associate Director, External Quality, Clinical Oral Solid Dosage (OSD) Key Responsibilities Provide proactive quality oversight for assigned clinical CXO partners/sites and programs (Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact). Ensure CXOs meet Gilead quality, regulatory, and compliance standards to support sustainable delivery of clinical products. Review and approve DS/DP manufacturing batch records, change controls, and deviations to enable timely disposition of DP for human clinical use. Serve as Quality Site Lead (QSL) for assigned CMOs and Alliance Partners; integrate acquired clinical assets. Lead Quality Agreement implementation and updates with CMOs. Participate in Business Review Meetings with CXOs as Quality’s voice for contract organization oversight. Ensure contract manufacturers are compliant and ready for regulatory inspections; monitor progress and support onsite inspections as needed. Partner with internal stakeholders (Global External Manufacturing, Global Clinical Supply Chain, Pharmaceutical Development, Reg CMC) to deliver the production plan and proactively address new requirements. Lead escalations and Material Review Boards for critical quality issues. Evaluate quality systems/processes; recommend and implement enhancements and training. Monitor CXO site trends and hold CXOs accountable to performance criteria and QAG requirements. Ensure GMP documentation accuracy and compliance with internal/external standards. Provide guidance to business teams on regulatory requirements. Establish Quality-to-Quality relationships between Gilead and CXOs. Review regulatory intelligence and timely communicate concerns, trends, gaps, and alerts to Quality management. Anticipate global regulatory compliance risks; champion Quality Risk Management. Travel to CXO site(s) for quality oversight of critical manufacturing activities (up to 20% based on strategic plan). Basic Qualifications Bachelor’s degree and 10 years’ experience Master’s degree and 8 years’ experience PhD/PharmD and 5 years’ experience Preferred Qualifications Knowledge of quality requirements for small molecule OSD manufacturing/testing/packaging/labeling, facility/utility/equipment and process qualification, new product introduction, contract operations, product release, disposition, and distribution. In-depth understanding and application of cGMP principles/standards (US and international) for clinical DS and DP (OSD). Ability to develop and improve complex concepts/techniques/standards and new applications based on quality principles. Knowledge of global product registration requirements/standards. Excellent verbal, written, and interpersonal communication skills. Expert in prioritizing competing projects/timelines. In-depth knowledge of technical/regulatory requirements for clinical small molecule manufacturing, testing, release, and outsourced operations (required). Biopharmaceutical or Pharmaceutical experience (required). Prior experience leading contract manufacturing/testing operations or overseeing contract manufacturing operations (required). Broad experience across CMO QA, drug development, packaging/labeling, and deep understanding of clinical OSD (DS and DP) (required). Prior people management experience (plus). Benefits Company-sponsored medical, dental, vision, and life insurance plans. #J-18808-Ljbffr Scorpion Therapeutics