Position

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.

About You

You are a hands-on GMP professional with experience developing, implementing, and maintaining the electronic quality management systems (eQMS) and processes. You value consistency, efficiency, and regulatory rigor while taking pride in building scalable, compliant quality systems through strong attention to detail and effective stakeholder partnership. You are comfortable balancing operational execution with continuous improvement in a fast-paced, growing organization.

What You’ll Do

• 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

Qualifications

• 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
• Preference for experience as a functional owner of electronic quality management systems and/or risk management tools

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 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​

The expected salary range for this role is $139,000 to $152,000 depending on skills, competency, and the market demand for your expertise.