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).

• Bachelor’s degree and 10 years’ experience
• Master’s degree and 8 years’ experience
• PhD/Pharm
  
  D and 5 years’ experience

• 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).

• Company-sponsored medical, dental, vision, and life insurance plans.