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Senior Manager, Quality Assurance
3 months ago
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.
Position
The Senior Manager, Quality Assurance will have a strong focus on GMP, ensuring compliance with industry regulations while fostering a collaborative, cross-functional environment. Reporting to the Sr. Director, Quality Assurance this individual will play a critical role in developing and maintaining quality systems, driving excellence across all GMP activities.
About You
You are a GMP professional with expertise in the development and launch of GMP operational systems and processes. You appreciate rules that govern activities. You appreciate consistency.
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 pharmaceutical setting. 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-siteThe 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.
In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
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.
