Director, Quality Systems & Validation

About the Role

The Director, Quality Systems & Validation is responsible for Neumora’s Quality Management Systems by overseeing the document control, training, and event reporting systems and managing the overall supplier management lifecycle, audits, and quality agreement programs. The position is responsible for ensuring that validation is conducted as appropriate on the GxP systems employed at Neumora.

The position represents QA in team settings and interfaces with cross-functional departments and contract service providers. Active leadership in sustaining a level of inspection readiness of, but not limited to, Neumora’s Quality Management System programs. Is a catalyst for continuous process improvement and manage the initiatives to implementation.

Responsibilities

• Oversees the management and development of QMS programs: deviations, events, CAPAs, change control, vendor/supplier lifecycle management; audit – vendor, clinical investigator site, self-inspection/audit; quality technical agreement; risk management.
• Oversees, maintains, and manages the process of qualifying, re-evaluating, determining risk score and status to vendors. Works with quality counterparts to ensure appropriate responses are provided and CAPA closured as part of the audit process.
• Creates, maintains, and manages master audit schedules.
• Manages and/or performs compliance audits according to established audit schedule or project objectives.
• Manages the creation/revision of quality technical agreements.
• Establishes, maintains, and manages key quality indicator (KQI) metrics program for the areas of responsibility.
• Oversees the internal audit program and ensures associated CAPA are closed according to established timelines.
• Performs, strategizes, and executes QMS reviews and gap analyses plus their resolution plans to ensure phase appropriate compliance and consistent QMS approaches.
• Supports regulatory submissions data integrity and compliance reviews and the review of ongoing updates to regulatory filings against source documentation. Ensures gaps identified are adequately remediated before submission.
• Leads the remediation of gaps identified in all areas of responsibility to assure cGMP compliance and inspection readiness.
• Supports the QMS compliance infrastructure, as needed, including, but not limited to, document control, training program, and quality event programs (e.g., Deviation, CAPA, Investigation, Change Control).
• Supports the facilitation of regulatory authority inspections.
• Collaborates within and across departments to ensure achievement of company goals, including compliance with all applicable standards and provide quality and compliance guidance.
• Creates and leads QA initiatives that drive quality management systems to a state of operational excellence.

Qualifications

• Bachelor’s degree in chemistry, biology, microbiology, industrial pharmacy, or other related scientific discipline with a minimum of 10 years’ experience in QA Compliance
• Other Compliance or Regulatory certifications (e.g. RAC, ASQ) a plus
• Experience working with a sponsor company from Phase I through commercial QMS
• Experience auditing suppliers, CRO, CMOs, CTLs, and clinical sites
• Experience with electronic QMS platforms (ex.Veeva)
• Practical knowledge of GxP and an ability to apply sound judgment and decision-making skills (risk based and appropriate for the phase of clinical development) to support product release
• Working knowledge of US and EU GxP regulations