Director, Clinical Quality Assurance (GCP)
About The Position
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. 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.
Requirements
- 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.
- 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.
- Demonstrated experience in conducting clinical trial audits and inspections.
Nice To Haves
- Additional certifications (e.g., RAC, CQA) highly desirable.
- Previous experience in pharmacovigilance auditing is a plus.
- Expertise in Veeva systems is a plus.
Responsibilities
- 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.
- 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.
- Stay abreast of industry trends, regulations, and best practices related to clinical quality assurance and GCP.
Benefits
- Bonus and equity compensation
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
