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
OR
- Master’s degree and 8 years’ experience
OR
- 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.

Application Instructions:
- Please apply via the Internal Career Opportunities portal in Workday.