Director, QA Systems and Compliance

The successful incumbent will represent QA in team settings and interface with cross-functional departments and contract service providers. The position requires active leadership in sustaining a level of inspection readiness of, but not limited to, Neumora’s Quality Management System programs. In addition, the individual must be a catalyst for continuous process improvement and manage the initiatives to implementation.

Oversee the management and development of the following QMS programs: vendor/supplier lifecycle management; audit – vendor, clinical investigator site, self-inspection/audit; quality technical agreement; risk management.

• Oversee, maintain, and manage the process of qualifying, re-evaluating, determining risk score and status to vendors. Work with quality operations to ensure appropriate responses are provided and CAPA closured as part of the audit process.
• Create, maintain, and manage master audit schedules.
• Manage and/or perform compliance audits according to established audit schedule or project objectives.
• Manage the creation/revision of quality technical agreements.
• Establish, maintain, and manage key quality indicator (KQI) metrics program for the areas of responsibility.
• Oversee the internal audit program and ensure associated CAPA are closed according to established timelines.

Perform, strategize, and execute QMS reviews and gap analyses plus their resolution plans to ensure phase appropriate compliance and consistent QMS approaches.

Support regulatory submissions data integrity and compliance reviews and the review of ongoing updates to regulatory filings against source documentation. Ensure gaps identified are adequately remediated before submission.

Lead the remediation of gaps identified in all areas of responsibility to assure cGMP compliance and inspection readiness.

Support 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).

Support the facilitation of regulatory authority inspections.

Collaborate within and across departments to ensure achievement of company goals, including compliance with all applicable standards and provide quality and compliance guidance.

Create and lead 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 global Phase I through commercial QMS
• Experience auditing suppliers, CRO, CMOs, CTLs, and clinical sites
• Experience with Veeva ideal
• 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 and guidelines required
• Working knowledge of other world GxP regulations and guidelines beneficial
• Strong organization and time management skills required with minimal oversight
• Strong leadership and influencing skills a must
• Willingness to travel approximately 30 to 35%

Company benefits include:

• Medical, dental, vision, and life insurance
• 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
• New hire stock options
• Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down
• Leave of Absence: Paid family leave, paid short- and long-term disability
• Discretionary year-end bonus

The salary range posted describes the minimum to maximum base salary range for this position in the location listed.  Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $ $188,163- $ 206,079