Manager/Sr. Manager, Training and Doc Control Support Systems

Manager/Sr. Manager, Training and Doc Control Support Systems

San Francisco - 1800 Owens 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 experimentationincluding the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

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

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

Salary

$135,700 - $185,000 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 BridgeBio Full-Time U.S 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 & Well-Being

• 100% employer-paid medical, dental, and vision premiums for you and your dependents
• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
• Fertility & family-forming benefits
• Expanded mental health support (therapy and coaching resources)
• Hybrid work model with flexibility
• Flexible, "take-what-you-need" paid time off and company-paid holidays
• Comprehensive paid medical and parental leave to care for yourself and your family

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, & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities