Job Description

What You’ll Do

Document Control & Training Manager will lead and manage Document Control activities for BridgeBio and its affiliates as well as perform training-related tasks to support the Training Program. This individual will develop and implement document management processes as well as perform document administration tasks in Veeva QualityDocs, ensuring that documents are in compliance with GxPs and with Good Documentation Practices. Document Control & Training Manager will also perform training-related tasks in the Learning Management System (Veeva Training) as needed. This individual will interact closely with internal stakeholders such as Quality Control, Manufacturing, Regulatory Affairs, Supply Chain, and Clinical.

Responsibilities

• Lead Document Control compliance and process improvement efforts
• Manage, plan, and coordinate document control activities and processes
• Manage documentation by processing, formatting, issuing the documents for training, and making it effective accurately
• Responsible for reviewing Document Change Controls to ensure proper revision control of records and closure
• Manage document periodic review process and coordinate with the stakeholders on its completion
• Perform Business Administrator activities in the electronic document management system (Veeva QualityDocs)
• Execute user test scripts for the electronic document management system during changes to the systems
• Manage Learner Roles, curriculums, and training requirements in the Learning Management System (Veeva Training)
• Support onsite audit/ and or in any regulatory inspections
• Perform other projects related to improvement of quality systems as needed and required by management
• Other duties as assigned

Where You’ll Work

This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office.

Who You Are

• Bachelor’s degree or higher
• Minimum 5-10 years of experience in a quality assurance role in the pharmaceutical industry required
• Experience with EDMS and LMS systems, preferably Veeva Quality Docs and Veeva Training
• Excellent knowledge and understanding of applicable GxP regulations
• Experience in the identification and resolution of Good Documentation Practices issues
• Familiarity with Microsoft Office Suite, Adobe Pro, etc.
• Ability to work in a fast-paced environment with excellent multi-tasking skills
• Must have attention to detail
• Works with minimal supervision
• Must have effective technical writing skills
• Requires excellent organizational, interpersonal, and communications skill
• Must exhibit professional behavior and be aware of the importance of teamwork within the assigned department
• Ready to embrace BridgeBio’s core values and diverse corporate culture