Manager, Quality Assurance (GMP/Document Control/Training)

Location: South San Francisco, CA

Position Purpose

The Manager, Quality Assurance will provide support for the Chemistry, Manufacturing and Controls (CMC) team’s outsourcing activities by review and approval of material and product specifications, master and executed batch records, shipping documentation and temperature excursion product impact assessments, product release testing certificates of analysis, production deviations, and maintain records of GMP outsourcing activities in Cortexyme’s electronic data management system.  The Manager, Quality Assurance will also maintain the document control system, tracking logs, training files, and perform internal audits of Cortexyme’s quality systems.  The role requires working with external vendors and internal subject matter experts to maintain a high level of GMP compliance and meet timelines for delivery of product.  This position reports to the Executive Director, Quality Assurance.

Essential Responsibilities

  • Support for GMP Operations  – Actively participate in frequent virtual meetings with external GMP vendors and will provide QA input on production and testing issues and ensure that timelines are adhered to.  Responsible for review and approval of master and executed batch records, review of product release testing certificates of analysis, generation of certificates of release, maintaining of product release files in Cortexyme’s electronic data management system.  The Manager will perform Initial review of production, testing deviations and out of specification investigations, and collaborative review/assessment of content, product impact, and corrective/preventive actions with the head of Quality Assurance and other Cortexyme subject matter experts.
  • Document Control – Responsible for maintaining document control logs, electronic storage of current and historical SOPs, forms, and specifications, and master and executed batch records and related documents. Additionally, responsible for the review of new and revised SOP and providing feedback to the submitting departments, circulation of SOPs, forms and specifications for review and approval by others using DocuSign.
  • Training – Maintenance of Cortexyme training system including notification of employees of new and revised SOPs that require training, review of completed training records for compliance with documentation requirements, filing of training records, updating of tracking systems for training records for the CMC, QA, and Clinical Operations departments.
  • Internal Audits – Responsible for maintenance of the internal audit schedule, performance/documentation of internal audits and self-audits of Cortexyme’s Quality Systems and working with internal departments to ensuring remediation of audit findings and closure of each internal audit. Elevate systemic issues to the head of Quality and develop/implement corrective actions as needed.
  • External Audits – Maintenance of external audit schedule, coordination with external vendors to establish audit dates, performance of on-site and virtual audits, authoring of audit reports and findings, follow-up with vendors to ensure resolution of issues. Report audit findings to the heads of QA and the outsourcing department.  Elevate compliance issues with clinical sites and vendors to the head of QA and the outsourcing.
  • Inspection Readiness – Actively lead efforts to sustain a level of inspection readiness of internal stakeholders. Responsible for preparing and coordinating with internal stakeholders for inspections to which notification has been provided with advance notice.

Qualifications

  • A minimum BS/BA degree, or equivalent, in science or related field of study
  • 8+ years of GMP quality assurance background in pharma/biotech with a hands-on role in quality operations and quality systems.
  • Hands-on experience managing day to day QA activities in a GMP production facility manufacturing active ingredients or final dosage form product is a requirement of the position.  Strong understanding of production and testing of solid oral dosage forms is benefit to the role.
  • Previous experience working in a GMP Analytical Chemistry laboratory (e.g., Analytical Development or Quality Control) is a plus.
  • Experience working with DocuSign, Box GxP, SmartSheets, PowerPoint, Zoom/Microsoft Teams.
  • Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations (21 CRF 211) is essential to the role.
  • 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.,).
  • 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.
  • Domestic and international travel may be required up to 15% of the time.

Travel Requirements

  • Domestic and international travel may be required up to 15% of the time.

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.

Apply to: careers@cortexyme.com