Site Quality Head

Role Summary

Site Quality Head at Gilead Sciences, Inc. Lead all Quality functions at the pharmaceutical manufacturing site, ensuring compliance with global regulatory standards, driving a culture of quality and continuous improvement, and serving as the primary quality authority for the site. Responsible for the strategic direction, operational execution, and leadership of Quality Assurance, Quality Control, and Compliance teams.

Responsibilities

• Develop and execute the site‚Äôs quality strategy aligned with corporate objectives and regulatory expectations.
• Serve as the site‚Äôs quality representative to global quality leadership and regulatory agencies.
• Ensure site-wide compliance with cGMP, FDA, EMA, ICH, and other applicable regulations.
• Lead regulatory inspections and audits, including preparation, hosting, and response management.
• Oversee Quality Assurance (QA), Quality Control (QC), and Compliance functions.
• Ensure timely release of products, materials, and batches in accordance with quality standards.
• Lead, mentor, and develop a high-performing quality team.
• Foster a culture of accountability, transparency, and continuous improvement.
• Serve as the final quality decision-maker for critical quality issues, deviations, and product disposition.
• Lead risk assessments and implement mitigation strategies.
• Partner with Manufacturing, Supply Chain, and Technical Development to ensure quality is embedded across all site operations.
• Represent Quality in site leadership forums and strategic initiatives.

Qualifications

• 16+ years‚Äô experience with a BS OR 14+ years with a MS, MBA, PhD or PharmD in a related field; or 8+ years with an MD degree.
• Prior experience in a Quality Assurance (QA) role with solid QA principles and practices.
• Extensive knowledge and experience in Biopharmaceutical or Pharmaceutical quality control; stays ahead of industry trends.
• Prior senior leadership experience required.
• Critical and creative thinking with the ability to work independently and determine appropriate resources.
• Strong organizational and planning skills; excellent verbal and written communication and collaborative interpersonal skills.
• Ability to work with senior executives and build rapport across levels.
• Understanding and application of GMP principles and standards in the US and internationally.
• Ability to develop and improve complex concepts, techniques, and standards based on quality principles.
• Experience developing a vision for Quality functions and shaping the function‚Äôs capabilities accordingly.
• Strong hiring and staff development skills, with the ability to motivate and engage individuals.

Skills

• Quality leadership and strategic planning
• Regulatory compliance and inspections
• Quality Assurance (QA) and Quality Control (QC) oversight
• Risk management and decision-making
• Cross-functional collaboration
• Strong communication and influencing abilities

Education

• BS with 16+ years experience or MS/PhD/MBA in a related field; or MD with 8+ years experience