Director, Clinical Quality Assurance

Director, Clinical Quality Assurance

San Francisco, California, United States · QED Therapeutics

DESCRIPTION

Reporting to the Vice President, Quality Assurance, the Associate Director of Clinical Quality Assurance is responsible for the development, maintenance, and oversight of Good Clinical Practice (GCP) activities related to clinical trials sponsored by QED. The primary responsibilities will be to ensure that both quality and compliance of QED-sponsored clinical trials with respect to company policies and procedures, applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices. The position will work closely with clinical study teams to manage and support a culture of quality, regulatory compliance, and continuous GCP inspection readiness.

Job Responsibilities:

  • Draft, review or revise clinical policies and procedures to assess consistency and compliance with regulatory requirements/internal standards
  • Attend cross-functional team meetings and provide GCP guidance to clinical study teams based on interpretation of current regulations to ensure best practices including risk-based management
  • Provide Quality Control (QC) review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, and other clinical trial related documents
  • Work closely with clinical study teams to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary
  • Work directly with CRO’s and other external contractors and collaborators, managing the chain of communication related to GCP compliance
  • Interact with contract auditors in the scheduling process, kick-off meetings with auditors and internal groups, assist in the drafting of audit plans, confirmation letters and agendas, etc.
  • Identify the need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs, and clinical labs)
  • Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process
  • Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation)
  • Assist and/or conduct GCP introductory and awareness training
  • Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation
  • As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management
  • Perform program-specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for overall QA reporting requirements to functional and senior management
  • Assist with inspection readiness, and regulatory inspections as needed
  • Other duties as assigned or required

Requirements:

  • BA/BS degree in life sciences, engineering or a related discipline required
  • 7+ years of direct GCP pharmaceutical/biotechnology experience
  • Solid understanding and application of GCP, GLP, and ICH requirements; specifically, ICH E6R2
  • Experience working in a start-up or fast-growing company preferred
  • Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, and GCP auditing
  • A well organized, self-motivated, and independent work style with the ability to initiate and follow through on assignments
  • Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
  • A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
  • Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
  • Experience using risk-based principles and decision making to ensure compliance at all stages of development (IND through commercialization)
  • Proven track-record of leadership and building relationships with both internal and external customers
  • Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges

If you are passionate about innovation and looking to join a thriving team, email your cover letter and resume to: careers@QEDTx.com

careers

Director, Clinical Quality Assurance