Director, Clinical Quality Assurance (GCP)

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

We are seeking an experienced and dynamic Director, Auditor, Clinical Quality Assurance to lead our GCP auditing efforts. The successful candidate will play a pivotal role in ensuring that our clinical trials adhere to Good Clinical Practice (GCP) guidelines and maintain the highest standards of quality. 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.

About You

You are an expert-level auditor with the discipline and consistent follow-through to see complex audit programs through to completion. You are an excellent communicator who builds trust and collaborates effectively with stakeholders. 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.

What You’ll Do

• Lead and manage the Clinical Quality Assurance (CQA) audit program, ensuring compliance with GCP, applicable regulations, and company SOPs.

• Provide leadership, mentorship, and functional guidance to CQA staff and/or contract auditors, and contribute to departmental strategy, budget, and resource planning.

• 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.

• Provide expert guidance to cross-functional teams on GCP compliance, protocol adherence, and regulatory requirements.

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