Associate Director / Director, Clinical QA

Cortexyme

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 05/05/2021
  • Website: cortexyme.com
  • Company Address: 329 Oyster Point Blvd. #300 South San Francisco, South San Francisco, CA, 94080

About Cortexyme

Cortexyme is developing therapeutics based on data supporting a new theory of the cause of Alzheimer's and other degenerative disorders. Cortexyme is targeting a specific, undisclosed pathogen tied to neurodegeneration and beta amyloid production. The target has been validated in a number of animal models and Cortexyme is currently moving a proprietary small molecule towards human clinical testing.

Job Description

Position Purpose

The AD/Director, Clinical Quality Assurance (CQA) will support the company’s Clinical Quality Assurance program.  The incumbent will assist in procedural development and maintenance for Quality Assurance oversight of Good Clinical Practice (GCP) operations internally and externally.  Position includes review of clinical documentation, performance of internal audits and authoring of reports, performance of external audits of clinical site and vendors.  Maintenance of clinical training records and training trackers.  Maintenance of a state of readiness for inspection.  The position requires close coordination with internal departments and global vendors to ensure continued compliance with regulations and guidelines.  Reports to Executive Director of Quality Assurance.

Responsibilities

  • SOP Development and Enhancement – Develop and maintain GCP-related quality system SOPs and forms to ensure compliance with regulatory requirements and guidelines. QA point-person for review and approval of new and revised SOPs authored by the Clinical Department.
  • Study Protocols, Brochures, Reports – Manage/conduct quality audits of clinical study documents, including but not limited to, investigator brochures, clinical protocols and clinical study reports, case report forms and informed consents forms. Ensure clinical trials are performed in accordance with study protocols and are in compliance with all applicable regulatory requirements.  Elevate issues to the heads of QA and Clinical.
  • Internal Audits – Maintenance of internal clinical audit schedule, coordination with the Clinical Department to establish audit dates, performance audits, authoring of audit reports and findings, coordinating with the Clinical Department to ensure resolution of issues identified and closure of audits. Identify compliance areas that cannot be quickly resolved and work with internal stakeholders to create written timelines and resources needed to address issues.  Assist the Clinical Department is development, execution, and closure of CAPAs.
  • External Audits – Maintenance of external audit schedule, coordination with clinical sites and external vendors to establish audit dates, performance of on-site audits, authoring of audit reports and findings, follow-up with clinical sites and vendors to ensure resolution of issues. Report audit findings to the heads of QA and Clinical.  Elevate compliance issues with clinical sites and vendors to the head of QA and Clinical.
  • Documentation Databases – Ensure maintenance of clinical documentation databases and other electronic systems (Trail Master File, etc.,).
  • Inspection Readiness – Actively lead efforts to sustain a level of inspection readiness of internal clinical stakeholders. Responsible for preparing and coordinating with internal stakeholders for inspections to which notification has been provided with advance notice.
  • Training – Responsible for maintaining electronic copies of training records for the clinical department and maintenance of clinical training trackers. Sending notifications to Clinical Department heads regarding training record deficiencies.  Develop and execute programs for training of clinical staff in current regulations and guidelines.
  • Support for Regulatory Affairs – Organization and submission of documentation to Regulatory Affairs to support IND and NDA submissions.  Coordinate responses to regulatory agency inspection

Qualifications

  • A minimum BS/BA degree, or equivalent, in science or related field of study
  • 7+ years of progressive global quality assurance background in pharma/biotech with a hands-on role in quality operations and quality systems
  • 5+ years hands-on CQA/GCP Compliance experience
  • Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations (21 CRF parts 50, 56, and 312), ICH Guidelines and other local government regulatory requirements governing clinical research.
  • Global clinical trial oversight preferred.
  • Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
  • Proficiency in using MS Visio, PowerPoint, Word, Excel, SmartSheets, electronic file storage systems (Box), digital communication platforms (Zoom, Microsoft Teams, etc.,).
  • Hands-on experience with clinical trials using solid oral dosage forms is a plus.
  • Position requires a highly diplomatic, tactful and detail oriented individual with exceptional critical reasoning skills.
  • Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
  • Ability to deal with ambiguity with a creative and pragmatic approach to problem solving
  • Travel will be required between 15 and 30% of the time
  • Auditor certifications a plus

Cortexyme is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, disability status or any other characteristic protected by law.

For more information on Cortexyme, visit www.cortexyme.com.

Related Jobs

Director, Process Chemistry

Cortexyme - South San Francisco, CA, US

Associate Director, CMC Project Management

Cortexyme - South San Francisco, CA, US

Senior RA / Scientist I: Molecular/Cell Biology

Cortexyme - South San Francisco, CA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.