Gilead Sciences · 1 hour ago
Site Quality Head
Gilead Sciences is a biopharmaceutical company dedicated to creating a healthier world by advancing innovative medicines for life-threatening diseases. The Site Quality Head will lead all quality functions at the manufacturing site, ensuring compliance with global regulatory standards and fostering a culture of quality and continuous improvement.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Develop and execute the site’s quality strategy aligned with corporate objectives and regulatory expectations
Serve as the site’s 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, Technical Development to ensure quality is embedded across all site operations
Represent Quality in site leadership forums and strategic initiatives
Qualification
Required
16+ years' experience with a BS OR 14 Years' experience with a MS, MBA, PHD or PharmD in a related field OR 8+ years' experience with an MD degree in related field
Prior experience in a Quality Assurance (QA) role, with a solid understanding of QA principles and practices
Extensive knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting trends in industry
Prior senior leadership experience required
Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems
Strong organizational and planning skills
Shows excellent verbal and written communication skills and collaborative interpersonal skills
Experience over a broad set of Quality sub-functions with extensive knowledge of industry best practices and trends
Ability to quickly establish credibility with diverse audiences and be perceived as a leader
Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills
Significant in-depth understanding of business objectives and how they translate into quality priorities
Must have the experience and confidence necessary to work with senior executives, and the ability to build rapport with employees at all levels
Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist
In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally
Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories
Demonstrated an ability to develop a vision for Quality functions and have shaped the capabilities of the function to fulfill that vision
Strong hiring and staff development skills, with the ability to motivate and engage individuals
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Recent News
2026-01-16
FierceBiotech
2026-01-16
Company data provided by crunchbase