Document Control & Training Manager

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.

Affiliate Overview

Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

What You'll Do

Document Control & Training Manager will lead and manage Document Control activities for BridgeBio and its affiliates and 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

• Manage, plan, and coordinate document control activities and processes
• Lead Document Control compliance and process improvement efforts
• Manage documentation by processing, formatting, issuing the documents for training, and making it effective and accurate
• 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 the 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 multitasking skills
• Must have attention to detail
• Works with minimal supervision
• Must have effective technical writing skills
• Requires excellent organizational, interpersonal, and communication skills
• 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

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities