Pioneering a new era of precision medicines for brain diseases
Director, Quality Systems – Validation
Location
United States
Posted
20 hours ago
Salary
$214.9K - $226.6K / year
Seniority
Lead
Job Description
Director, Quality Systems – Validation
Neumora
• 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.
Job Requirements
- 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 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 5 to 15% (varies based on activities per month)
Benefits
- Medical, dental, vision, and life insurance
- 401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
- Company Equity (New Hire Awards, Annual Awards, ESPP)
- Annual paid time off:
- Accrued Vacation Days: 15 days per year
- Sick Days: 10 days per year
- Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December
- Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability
- Discretionary year-end bonus
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