Quality Documentation and GxP System Specialist

Alto Neuroscience • Mountain View, CA

13d • $120 - $145 • Onsite

About The Position

This position serves as a critical role to ensure that Alto GXP employees have the procedural tools and training to perform their job. Heavy collaboration with functional area management to create/revise Controlled Documentation, review necessary training and other procedural tools. Responsible for implementing GxP training across the Alto organization. Owns the GxP systems across the organization and works with the functional area representation to maintain CFR Part 11 Compliance and associated system validation. Assist with Inspection Readiness and have key role in supporting Regulatory Agency inspections.

Requirements

• BS/BA or equivalent training and experience
• 5+ years of experience working in a biotech/pharma company / CRO/ Document Management.
• Basic understanding of study and site management and overall trial planning and execution.
• Working understanding ICH-GCP guidelines, Code of Federal Regulations and ex-US regulatory regulations.
• Direct involvement in preparing an organization for Inspection Readiness as well as having participated in or supported regulatory inspections in the past.
• Ability to work independently and collaboratively, as required, in a fast-paced environment consisting of internal and external team members.
• Analytical problem solver with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Tolerance of ambiguity and willingness to work through complex issues.
• Strong work ethic, organizational skills, oral and written communication skills, have a 'can do' approach, and problem-solving skills.
• Good verbal and written communication skills
• Ability to multi-task and lead several projects in parallel while paying attention to detail.
• Strong critical thinking skills and ability to supply creative yet practical solutions to problems.

Responsibilities

• Lead the Quality onboarding / offboarding mandatory of Alto employees, including ensuring access to GxP systems are maintained
• Work with Quality Sr Leaders to ensure removal access to GxP systems and complete requisite records for offboarding.
• Lead any future GxP System implementation and adherence to GxP System Plans which includes: validation maintenance, access control, software upgrades/releases, and periodic system review in accordance to CFR Part 11 compliance.
• Lead or guide Cross Functional Area Subject Matter Experts (SMEs)/Leads in the creation or revision of Controlled Documentation to define processes in alignment with established regulatory regulations.
• Maintain hierarchy, completeness, and integrity of Controlled Documents in the Quality Document Management System (QDMS).
• Maintain accurate required training records for Alto employees in accordance with established guidelines.
• Oversee the development and implementation of communications to ensure Alto employees are properly informed of new/revised Controlled Documents and associated training timelines.
• Provides Alto Management with training metrics and KPIs and escalate issues when necessary.
• In collaboration with Cross Functional Area Leaders, explore use of the GxP validated systems to maintain inspection supporting documentation.
• Identify opportunities for continuous process improvement.
• Play a key role in preparing the organization in Inspection Readiness activities.
• Provide assistance during inspections by pulling relevant documentation from the QDMS.
• Maybe be called on during regulatory inspection to discuss maintenance of GxP validated systems and/or maintenance of the QDMS.
• Provide GCP assistance to Sr Director and/or VP of Quality.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level