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

JobRx, Inc.; Owens (OH); Hybrid; USD 120,000 - 150,000; Full time

Job summary

BridgeBio is seeking a Document Control & Training Manager to lead document control activities across BridgeBio and affiliates, ensuring GxP compliance and proper training administration in Veeva systems.

You will interact with Quality Control, Regulatory, and Manufacturing teams to streamline processes, execute training tasks, and support audits and inspections. Hybrid role in a US office, with emphasis on accuracy and process excellence.

Qualifications

• Bachelor's degree or higher.
• 5-10 years of experience in a quality assurance role in the pharmaceutical industry.
• 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.

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

Skills

Attention to detail

Multi-tasking

Fast-paced environment adaptability

Quality mindset

Education

Bachelor's degree or higher

Tools

EDMS

LMS systems

Job description

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.

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