Director, Quality Control Stability and Reference Materials

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

Scope of Responsibilities

1. Global Process Ownership Design & Governance

• Define and own the enterprise-wide strategy vision and multiyear roadmap for Stability Program Management and Reference Standards & Analytical Controls aligned with Gileads Quality and business strategies.

• Design own and maintain global policies standards procedures governance models and decision frameworks that ensure consistent compliant execution across development and commercial networks.

• Serve as the final global authority for interpretation application and risk-based decision-making related to Stability and Reference Materials processes.

• Establish and maintain clear global governance RACI and decision rights resolving cross-site and cross-functional complexity.

• Ensure alignment and integration with upstream and downstream Quality and Technical processes through close collaboration with other Global BPOs.
  

2. Implementation Enablement & Adherence

• Oversee and direct global implementation strategies for new or revised processes ensuring scalable sustainable adoption.

• Sponsor development of training frameworks role-based enablement certification expectations and change management approaches in partnership with Quality Learning and OCM.

• Provide expert-level guidance on complex or ambiguous process application including escalation and resolution of systemic adherence issues.

• Drive global harmonization and simplification including alignment across internal sites and external/contract testing laboratories.

3. Process Performance Monitoring & Risk Management

• Define monitor and govern enterprise-level KPIs and performance indicators for Stability and Reference Materials.

• Provide portfolio-level oversight of process health by integrating data from audits inspections deviations investigations complaints stability trends and reference standard performance.

• Identify assess and communicate systemic quality and compliance risks with potential regulatory or supply impact.

• Translate technical risk signals into business-relevant insights to support senior leadership decision-making.

4. Inspection Readiness & Regulatory Engagement

• Act as the global process authority during regulatory inspections and health authority interactions related to Stability and Reference Materials.

• Lead and coordinate inspection strategy messaging and responses for assigned process areas.

• Proactively monitor and interpret evolving global regulatory expectations and industry trends advising leadership on strategic implications and required actions.

• Represent Gilead externally in regulatory industry or benchmarking forums as appropriate.

5. Continuous Improvement Innovation & Transformation

• Set the enterprise continuous improvement and transformation agenda for Stability and Reference Materials.

• Lead continuous improvement and change management applying Lean principles to process design and execution.

• Actively seek and incorporate feedback from users and stakeholders; facilitate the sharing and adoption of best practices and lessons learned across the global network.

• Create and direct improvement strategies initiatives and roadmaps that enhance compliance efficiency and effectiveness including adoption of new and emerging technologies to automate error-proof or enable disruptive improvements.

• Lead or sponsor global projects and programs in support of Quality transformation and enterprise Quality strategy.

6. Cross-Functional Leadership & Network Management

• Lead and sustain a global matrixed network of senior SMEs and functional leaders influencing without direct authority.

• Act as a trusted advisor to Quality Technical Operations Regulatory and R&D leadership on Stability- and reference-related strategy and risk.

• Provide coaching and strategic guidance to stakeholders shaping consistent high-quality execution and organizational capability.

• Resolve complex cross-functional issues through enterprise-level influence and alignment.

7. Digital Enablement & Quality Systems Oversight

• Partner with IT system owners to manage business requirements and BAU processes for supporting Quality IT systems (e.g. LIMS QMS data trending platforms).

• Ensure supporting Quality IT systems meet GxP and regulatory requirements.

• Approve IT system changes and the release of new or revised functionality into the production environment ensuring validated and compliant deployment.

Qualifications
Required

• Bachelors degree in Life Sciences Chemistry Engineering or related discipline.

• 12 years experience in Quality Control Analytical Development Stability or Quality Systems within regulated environments.

• Demonstrated success operating at a strategic enterprise level with global accountability.

• Recognized expertise in ICH stability expectations and reference standard governance.

• Proven experience advising senior leadership and representing processes during regulatory inspections.
  Preferred

• Prior experience as a Global Business Process Owner enterprise Quality lead or equivalent director-level role.

• Experience leading enterprise transformation or digital Quality initiatives.

• Experience with global digital quality systems (LIMS QMS statistical trending platforms).

• Strong executive presence with the ability to influence strategy across functions and levels.
  

Key Competencies

• End-to-End Process Ownership & Systems Thinking

• Global Leadership & Influence

• Quality Compliance & Risk-Based Decision Making

• Data-Driven Performance Management

• Change Leadership Communication & Continuous Improvement
  

Travel Requirements
1020% travel for audits inspections workshops site harmonization activities and process deployment.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.