Gilead Sciences · 21 hours ago
Senior Manager, Quality – Combination Products, Compliance
La Verne, CA
Full-time
Onsite
Senior Level
$143K/yr - $185K/yr
6+ years expGilead Sciences is dedicated to creating a healthier world by tackling major diseases and ensuring access to therapies. The Senior Manager, Quality role is a key leadership position responsible for managing compliance for combination products at the La Verne site, ensuring adherence to quality management standards and regulations.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Monitor medical device standards for quality management system (QMS) updates to ensure adherence to global regulations
Monitor device/combination product enforcement trends in the industry and develop recommendations and action plans for QMS improvement
Participate in external industry committees and ensure compliance with applicable medical device and combination product regulations
Participate in the development and rollout of device standards lists by product types and families
Coordinate and lead the process mapping and change for the development, revision, and maintenance of applicable department SOP’s, job aids, and WI’s
Engage with stakeholders across various functions when creating/revising QMS processes
Lead gap assessments against new regulations and relevant inspectional observations, and perform impact assessments as required
Participate in evaluations of medical device reports (MDRs) and provide documented justifications for reportable and non‑reportable regulatory decisions
Support medical device and combination product inspectional readiness activities and regulatory inspection responses
Assist with internal and external audits and inspections, acting as an SME and providing follow-up support as required
Support combination product complaints process and investigations and relay findings to the design and development team
Evaluate information from a QA technical perspective to ensure appropriate analysis and risk prioritization
Compile and analyze data, metrics, and trends associated with combination product processes
May manage Quality personnel (contract or FTE), including organizing and prioritizing daily tasks, conducting training, and writing performance reviews
Qualification
Required
Master's degree in a Science or Engineering field with 6+ years of relevant experience with medical device manufacturing, testing or QA experience
OR
Bachelor's degree in a Science or Engineering field with 8+ years of relevant experience with medical device manufacturing, testing or QA experience
Preferred
Experience with combination devices (e.g., autoinjectors, co-packaged kits, pre-filled syringes)
Demonstrated in-depth knowledge of Quality principles, concepts, industry practices, and standards
Familiarity with end-to-end lifecycle QMS management
Strong project management and process improvement skills
Demonstrated keen understanding of U.S. and international quality systems regulations to adopt best-in-class systems and drive continuous improvement initiatives
Knowledge of applicable standards, including 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366
Preferred knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics
Knowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or FMEA is preferred
Certification by ASQ (such as CQA, CQE, or CQM) or other industry-recognized professional organizations is preferred
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.
10001+ employees
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
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-09
2026-01-08
2026-01-07
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