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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) will support the company’s Clinical Quality Assurance program. Responsible for the compliance oversight of clinical studies performed by or on the behalf of Neumora as Sponsor. Responsible for the development of new and improvement of existing Good Clinical Practice (GCP) processes/Quality Management Systems (QMS). Manages and participates in global clinical quality operations and liaison of clinical quality related issues with Neumora’s related functional department. Performs audits of vendors, study sites, and internal processes. Ensures timely completion of goals and program activities according to organizational timelines. Reviews and collaborates on regulatory submissions as well as hosts and facilitates regulatory inspections.
Executes cQA tasks independently; effectively represents cQA in a GCP driven team setting and manages quality related activities at clinical vendors, investigator sites and with regulatory agencies.
Actively manages Neumora programs to an appropriate level of inspection readiness in collaboration with Neumora’s clinical stakeholders and acts as a catalyst for continuous process improvement. Effectively communicates compliance related metrics, risk, and compliance challenges to Executive management is a must.
Responsibilities:
• Oversee the development, implementation, and oversight of GCP related QMS SOPs and Policies in compliance with all applicable regulations.
• Ensure clinical trials are performed in accordance with applicable study protocols and global regulations as apply.
• Manage cQA consultants and contractors.
• Manage and oversee all aspects of cQA at clinical vendors.
• Create/manage/maintain quality plans for the cQA department.
• Perform and / or manage staff performing quality audits of investigator sites and clinical vendors.
• Perform and / or manage quality reviews of clinical study documents, which include but is not limited to investigator brochures, clinical protocols and clinical study reports, case report forms, informed consents forms, DSURs, clinical study plans, protocol deviations, and protocol amendments.
• Perform/manage internal audits to ensure stakeholder system compliance with existing policies and procedures, and GCP regulations, standards, and guidelines.
• Provide expert CQA advice and strategic guidance to stakeholders (e.g., Clinical Operations, Clinical Development, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of GCP regulations.
• Support the administration of the company’s training program by overseeing the conduct of GCP training to internal departments and externally, as applicable.
• Manage/conduct targeted training of investigators/site staff.
• Report GCP related deficiencies and associated risks to executive management as well as plans for risk mitigation and corrective and/or preventive actions (CAPA).
• Assist clinical study teams in the development of risk mitigation plans and CAPAs.
• Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to executive management.
• Coordinate responses to regulatory agency inspections.
• Review regulatory submissions for clarity, accuracy, data integrity, and compliance to current applicable regulations.
• Participate on Core Teams as the CQA program lead.
• Create and drive performance to cQA goals and budgets.
Qualifications:
• Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other global regulatory requirements governing clinical research.
• Global clinical trial oversight required
• 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.
• 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 between 25% and 30% of the time.
• Auditor certifications a plus.
• 8+ years of progressive global quality / regulatory compliance background in pharma/biotech and medical device industries, with a hands-on role in clinical quality operations and quality systems development.
• B.S./M.S. in relevant science field.
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: $191,308- $210,000
