Senior Manager, Quality Assurance

Position

Seeking a Senior Manager, Quality Assurance to join our growing organization.  This role will be instrumental in driving our clinical programs forward and developing our internal processes and procedures.

About you

The ideal candidate must be self-starting, and have a hands-on, do what’s necessary to get the job done approach. You should be a great team player and have broad QA experience within the pharmaceutical/biotech industry.  Your organizational skills, attention to detail, and ability to manage complex tasks and competing priorities will be crucial in this role as well as your experience developing and implementing processes and procedures. A Senior Manager of QA will need to be an effective communicator, have superior collaboration skills, and the ability to influence others in addition to maintaining a growth mindset.

What You'll Do

• Assist with the development and implementation of GMP quality systems in accordance with ICH, FDA, EMA, global regulations and industry guidance
• Review all documents/reports especially as they relate to method development, validation activities and other analytical activities
• Provide compliance oversight for internal and contracted external GMP activities
• Coordinate and/or perform virtual or on-site audits as needed
• Provide quality oversight for GMP CDMOs (including quality agreements) and manage GMP product batch record review and disposition.
• Assist with the development, implementation, and management of quality management systems including supplier management, change control, product label review, risk management, deviation and CAPA systems, etc.
• Ensure and record periodic SOP trainings for all GMP employees including onboarding FTEs and contractors in the GXP system as applicable

Qualifications

• Post Graduate degree with 6+ years of relevant experience or a Bachelor’s degree with 8+ years of relevant experience in a relevant scientific field (Biology, Chemistry, or related) or equivalent experience is required.
• Proven, extensive knowledge of worldwide GXP regulatory requirements, industry practices, and ability to apply concepts. Experience with GMP regulations and current industry standards.
• Experience in implementing quality systems and risk management tools
• Experience interacting with and/or managing CMOs for DS and DP, and clinical supplies
• Excellent interpersonal, verbal, and written communication skills are critical in our collaborative work environment
• Must demonstrate high organizational, prioritization and management proficiencies as well as effective problem solving
• Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities

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 $148,000 to $161,500 depending on skills, competency, and the market demand for your expertise.