Director, Clinical Quality Assurance (GCP)

About the role

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.

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.

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.
• Previous experience in pharmacovigilance auditing is a plus.
• Expertise in Veeva systems is a plus.
• Ability to travel up to 50% (domestic and international).

Qualifications

• Additional certifications (e.g., RAC, CQA) highly desirable.
• Expertise in Veeva systems is a plus.
• Ability to travel up to 50% (domestic and international).

Benefits

• 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

Pay

The expected salary range for this role is $204,000 to $246,750 depending on skills, competency, and the market demand for your expertise.

Schedule

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.