Eikon Therapeutics · 5 hours ago
Quality Assurance Manager
Millbrae, CA
Full-time
Onsite
Senior Level
$139K/yr - $152K/yr
6+ years expEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. The Quality Assurance Manager supports CMC operations by ensuring compliance with global regulatory requirements while fostering a collaborative, cross-functional environment. This role provides day-to-day support and execution of quality systems and GMP quality assurance activities across internal and external operations.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
Serve as functional owner of eQMS workflows, including (but not limited to) training, document control, change control, deviations, and CAPAs
Administer document control activities within the EDMS
Act as GMP training administrator, ensuring training curricula are created, assigned, and maintained for employees and contractors
Partner cross-functionally to support GMP readiness, drive continuous improvement initiatives, and mature the quality management system
Review executed production records, and conduct disposition activities
Support the development, implementation, and maintenance of GMP quality systems in accordance with ICH, FDA, EMA, and other global regulatory requirements
Provide quality oversight for internal GMP activities, proactively identifying, escalating, and mitigating quality risks
Qualification
Required
Bachelor's degree with 8+ years of relevant experience or a Post Graduate degree with 6+ years of relevant experience in pharmaceutical quality assurance disciplines
Extensive knowledge of GMP regulatory requirements and industry practices, with demonstrated application in process improvement and system optimization
Experience in pharmaceutical manufacturing quality assurance and/or batch release functions
Strong interpersonal, verbal, and written communication skills, with the ability to collaborate effectively across technical and non-technical teams
Demonstrated ability to prioritize independently, solve problems effectively, and exercise sound judgement
Demonstrated ability to operate successfully in a fast-paced company environment with tenacity to seamlessly adapt with evolving priorities
Preferred
Preference for experience as a functional owner of electronic quality management systems and/or risk management tools
Benefits
401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site
Company
Eikon Therapeutics
Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.
201-500 employees
H1B Sponsorship
Eikon Therapeutics 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 (12)
2024 (17)
2023 (7)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M
Leadership Team
Roger Perlmutter
Chairman, President, and CEO
Michael Klobuchar
Chief Operating Officer
Recent News
pharmaphorum
2026-01-14
2026-01-14
2026-01-12
Company data provided by crunchbase