Clinical Quality Assurance Manager

2 weeks ago

Menlo Park, California, United States Corcept Therapeutics Full time

The Manager of Clinical Quality Assurance (CQA) plays a vital role within the CQA team, overseeing daily clinical quality operations and compliance tasks essential for the successful execution of clinical trials supported by Corcept Therapeutics.

Key Responsibilities:

  • Oversee and conduct Good Clinical Practice (GCP) audits, which encompass clinical investigator site evaluations, clinical vendor assessments, internal audits of clinical departments, Trial Master File (TMF) reviews, and audits of relevant study documentation, including Clinical Study Reports (CSRs).
  • Act as a QA representative, offering compliance guidance to clinical study teams.
  • Engage in the review and endorsement of clinical study documents and clinical Standard Operating Procedures (SOPs) / Guidance Documents.
  • Ensure adherence to study-specific Study Audit Plans for assigned programs by implementing a risk-based approach for Corcept clinical studies.
  • Evaluate and authorize investigational product (IP) temperature excursions to guarantee timely release or rejection of IP.
  • Drive continuous enhancement of the Clinical Quality Management Systems (CQMS) and associated processes, including the development and revision of SOPs for GCP compliance and excellence.
  • Facilitate inspection readiness activities for GCP.
  • Assist in clinical inspections carried out by regulatory bodies, including sponsor inspections, clinical investigator site evaluations, and contract research organization (CRO) inspections.
  • Support inspections related to Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Pharmacovigilance (PV).
  • Lead investigations into clinical non-compliance events and implement Corrective and Preventive Actions (CAPA).
  • Conduct quality metric analysis for CQA, encompassing study quality event trends from clinical process deviations and CAPAs, including reviews of protocol deviations, safety, and other clinical data.
  • Maintain up-to-date knowledge of agency and industry trends, standards, and methodologies pertinent to GCPs, along with managing the GCP regulatory surveillance program.
  • Provide cross-training development opportunities for QA team members and mentor junior QA staff as needed.
  • Willingness to travel as required.

Preferred Skills, Qualifications, and Technical Proficiencies:

  • Comprehensive understanding of Quality Systems that underpin GCP quality activities.
  • Experience in developing GCP processes aligned with industry best practices and training.
  • Proficient in Microsoft Office applications.

Preferred Education and Experience:

  • Bachelor's degree in a science-related field or equivalent experience.
  • A minimum of 6 years of experience in clinical research.

The compensation range that Corcept Therapeutics anticipates for this position is between $144,800 and $170,300; the final offer may differ based on legitimate factors, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must possess current authorization to work in the United States on a full-time basis.

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