Senior Manager, Quality Assurance

Eikon 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. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Please note that starting April 2025, Eikon Hayward positions will be moving to our new headquarters in Millbrae, CA

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.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.