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.
Requirements
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
Salary
$135,700 - $175,000 USD
As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
For USA based roles:
Financial & Rewards
Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
Health &
Benefits
Health insuranceVision insurance401(k)Equity / stock optionsPerformance bonus
Additional Information
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
Bridgebio · San Francisco - 1800 Owens