- Job Type: Full-Time
- Function: Engineering QA
- Industry: Biotechnology
- Post Date: 11/20/2023
- Website: eikontx.com
- Company Address: 3929 Point Eden Way, Hayward, CA 94545
About Eikon TherapeuticsEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the interface of biology, engineering and chemistry 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.
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.
The Senior Director of GMP Quality Assurance will spearhead both the Quality Assurance (QA) and Quality Operations (QO) functions, ensuring optimal quality and GMP compliance across our product range. This key role is pivotal in ensuring the safety, efficacy, and quality of our products from research and development to market release.
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. You are analytical, detail-oriented, and you have a solution-driven mindset.
What You’ll Do
· Design and articulate a clear quality vision, strategy, and objectives, ensuring alignment with the company's overall mission.
· Oversee the development, implementation, and maintenance of the Quality Management System (QMS) or eQMS in compliance with global GMP standards.
· Ensure seamless coordination between QA (policy, compliance, audits) and GMP operational teams (CMC, supply chain).
· Integrate quality considerations into the broader strategic planning of the company.
· Guarantee all processes are consistent with international and local GMP regulations and standards.
· Stay updated with GMP regulatory changes and adjust company processes and policies accordingly.
· Proactively identify potential quality risks and formulate mitigation strategies.
· Champion a proactive approach to risk assessment and mitigation throughout the product's lifecycle.
· Evaluate, qualify, and monitor suppliers and contract manufacturers to ascertain their alignment with company quality standards and GMP compliance.
· Lead external audits and guarantee supplier and manufacturer adherence to stipulated requirements.
· Lead internal quality audits, identify areas for enhancement, and drive initiatives for continuous quality improvement.
· Manage and host regulatory inspections, ensuring the company is always inspection-ready.
· Lead, mentor, and expand the Quality team spanning both QA and QC functions.
· Cultivate a culture of excellence, teamwork, and ongoing improvement within the quality divisions and the larger company.
· Bachelor's degree in Life Sciences, Pharmacy, or a related field and 10+ years’ experience in a quality leadership role within the biopharmaceutical sector.
· Comprehensive understanding of GMP regulations and standards.
· Demonstrated expertise in setting up QMS systems and managing regulatory inspections and audits.
· Strong leadership qualities, combined with excellent interpersonal and communication capabilities.
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 $226,000 to $260,000 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.