PRIMARY ROLE:

Responsible for the development, maintenance, and oversight of GCP activities related to overall drug development. Responsibilities are to ensure quality and compliance of GCP drug development activities with respect to company policies and procedures, applicable regulatory standards and practices. The position will work closely with Clinical Development and Clinical Operations to support a culture of quality, regulatory compliance, continuous improvement and ensure Alto is inspection ready.

DUTIES AND RESPONSIBILITIES:

Quality Management

• Assist with the implementation of a comprehensive Quality Management System (QMS) at Alto to ensure global regulatory compliance and industry standards are met
• Maintain an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Clinical Quality activities
• Independently initiate and manage the development, review and approval of SOPs in compliance with applicable regulatory requirements
• Ensure appropriate training, qualification and information for GXP-personnel
• Oversee deviations management and applicable corrective and preventive actions program
• Help drive lessons learned and continuous improvement of clinical quality-related processes
• Assist with GCP audits, including vendor, site and internal audits
• Participate in quality issue resolution with the study teams and associated vendors

Compliance / Inspection Readiness

• Manage efforts to ensure readiness of GCP activities for pre-approval and routine agency inspection-readiness, corrective action programs, including overseeing the development of risk assessment strategies for managing and evaluating risk
• Ensure that essential GCP documentation is in the TMF with no gaps and meets the quality standards required for Regulatory Inspections
• Work with Clinical team and vendors to close gaps on essential documents that are missing or need corrections
• Key individual in the management of an Inspection to pull specific documented evidence to fulfill inspection requests and assist with the overall inspection process

LOCATION

Remote: Able to travel (<20%) to support team, audits etc.

SALARY RANGE

$210,000-$240,000 per year

QUALIFICATIONS

• Bachelors degree in a scientific or operational discipline relevant to the life sciences arena or equivalent
• Minimum of 8+ years experience in Quality Assurance
• Hands-on experience working in GCP clinical development
• Proficiency in interpreting and implementing GXPs, FDA, EMA, ISO and ICH Regulations and guidelines
• Excellent interpersonal skills, ability to interface and communicate effectively with management and other functions within the organization
• Ability to influence behaviors and negotiate and resolve challenges with poise, tact and diplomacy
• Very good communication skills in English, written and verbal (additional language skill advantageous)
• Excellent planning and strong organizational skills, able to manage multiple tasks simultaneously and set priorities
• Excellent conceptual science thinking, which is used to approach and solve complex issues and their implications
• Self-motivated and able to work independently in a fast-paced, small company environment
• Pro-active and strong problem-solving attitude
• Personal resilience, perseverance, energy and drive
• Team player, open personality and collaborative attitude

Alto Neuroscience, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law.