Director, Clinical and Non-Clinical Quality Assurance Audits

At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline.

The Director, Clinical Quality Assurance (cQA) Audits will contribute to the company’s Clinical Quality Assurance Audit Program, driving the development of the annual master audit schedule across GCP, GLP, and PV. This role will be responsible for selecting investigator sites to audit, contributing the vendor audit schedule, and selecting internal areas to audit. This role will assess and evaluate adherence to protocols, SOPs, study plans, contractual agreements, and regulations. The Director, Clinical and Non-Clinical Quality Assurance Audits will ensure that all audit activities are resourced appropriately including audit conduct and reporting, review and acceptance of audit responses, and timely tracking of CAPAs. In addition, this role will establish and report metrics and trends quarterly. This role requires a high degree of professionalism. The ability to effectively collaborate and communicate with internal and external stakeholders is key for the success of this role.

Responsibilities

• Drive the development of the annual master audit schedule across GCP, GLP, and PV, with a focus on clinical investigator site audits. Close collaboration with Quality Compliance and System Validation is required.
• Contribute to the annual vendor audit schedule, ensuring CROs and vendors that perform GCP, GLP, and PV activities undergo initial and re-qualification audits.
• Ensure all audits are resourced by either performing the audits directly or working with consultants when needed.
• Finalize and distribute audit reports according to established timelines. Review audit reports for audits that are outsourced, ensuring observations are factual and clear.
• Approve audit responses and track CAPA completion. Work directly with auditees to ensure audit responses are adequate and CAPAs address the identified root cause(s). This includes investigator sites, CROs, and vendors.
• Escalate potential critical audit observations when appropriate.
• Act as SME for any audit observations that may also be considered a serious breach.
• Create audit-related metrics including trending of observations, audit response time, and CAPA completion. Present audit metrics quarterly in appropriate forums.
• May perform quality reviews of clinical and pre-clinical study documents, such as investigator brochures, clinical protocols, clinical study reports, case report forms, informed consents forms, DSURs, clinical study plans, pre-clinical study reports, etc.
• May contribute to the company’s training program by providing root cause analysis and CAPA development training to internal and external stakeholders.
• Oversee consultant auditors as needed.
  
  

Requirements

• B.S./M.S. in relevant science field.
• 10+ years of progressive global quality/compliance background in pharma/biotech and medical device industries, with a hands-on role in clinical quality operations.
• Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH GCP Guidelines and other global regulatory requirements governing clinical and pre-clinical research.
• Auditor certification highly desirable.
• PV experience preferable.
• Excellent verbal and written communication skills, ability manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
• 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, creative and pragmatic approach to problem solving.
• Travel will be required approximately 50% of the time.
  
  

2024 Company Benefits Include

• 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- 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: $191,308- $210,000

Neumora Therapeutics is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of multiple clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.

Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.