Eikontherapeutics

Director, Clinical Quality Assurance (GCP)

Jersey City, NJ; Millbrae, CA · Director

Sponsorship not specified$204k-$247kDetected 23 hours ago

GCPAuditingClinical TrialsPharmacovigilanceLeadershipCommunicationProblem SolvingMentoringGxP

About the role

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.
This includes internal audits, site audits, and vendor audits.
This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices.

Lead and manage the Clinical Quality Assurance (CQA) audit program, ensuring compliance with GCP, applicable regulations, and company SOPs.
Lead quality management system (QMS) assessment for service providers and collaborate closely with Clinical Development Vendor Oversight team to ensure service provider qualification process is robust and timely.
Develop and execute risk-based audit plans, conduct audits of clinical trial activities, and provide timely and accurate audit reports.
Collaborate closely with the Clinical Operations team to identify and address quality related issues, deviations, and non-compliance events.
Review and approve essential study documents, including protocols, informed consent forms, and clinical study reports.
Contribute to the development of procedural documents (e.g., SOPs and WIs).
Develop and implement GCP training programs for internal staff and external partners/vendors involved in clinical trials.
Own and lead inspection-readiness strategy across the clinical development portfolio, including planning and facilitating mock inspections.
Represent the company in regulatory inspections and audits and lead the preparation and response efforts.

12+ years of progressive experience in clinical quality assurance or a related field in the pharmaceutical or biotechnology industry with a Bachelor's degree, or 10+ years of
equivalent experience with an advanced/post-graduate degree.
Extensive knowledge of GCP guidelines, ICH E6(R2), and other relevant regulatory requirements.
Demonstrated experience in conducting clinical trial audits and inspections.
Ability to travel up to 50% (domestic and international).
You are an expert-level auditor with the discipline and consistent follow-through to see complex audit programs through to completion.
equivalent experience with an advanced/post-graduate degree. Additional certifications (e.g., RAC, CQA) highly desirable.
Strong leadership, analytical, and problem-solving skills, with meticulous attention to detail and accuracy.
Exceptional communication and interpersonal skills, with a proven ability to lead and collaborate in a cross-functional team environment.
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

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

You thrive as part of a dynamic team, and you're motivated by the opportunity to drive projects and results while mentoring and developing others.

This listing is sourced directly from Eikontherapeutics's careers page and normalized into a canonical job model.