What Youโll Do
Document Control & Training Manager will lead and manage Document Control activities and perform training-related tasks to support the Training Program. Develop and implement document management processes and administer documents in Veeva QualityDocs to ensure compliance with GxPs and Good Documentation Practices. Perform training-related tasks in Veeva Training (Learning Management System) as needed. Partner with 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
- Process, format, issue training documents, and ensure accuracy
- Review Document Change Controls to ensure proper revision control and closure
- Manage the document periodic review process with stakeholders
- Perform Business Administrator activities in Veeva QualityDocs
- Execute user test scripts in the electronic document management system during changes
- Manage Learner Roles, curriculums, and training requirements in Veeva Training
- Support onsite audits and regulatory inspections
- Perform other quality system improvement projects as needed; other duties as assigned
Where Youโll Work
Hybrid; in-office collaboration 2โ3x/week in San Francisco, CA.
Who You Are (Qualifications)
- Bachelorโs degree or higher
- 5โ10 years of experience in a pharmaceutical quality assurance role (required)
- Experience with EDMS/LMS systems, preferably Veeva QualityDocs and Veeva Training
- Excellent knowledge of applicable GxP regulations
- Experience identifying and resolving Good Documentation Practices issues
- Familiarity with Microsoft Office Suite and Adobe Pro
- Fast-paced environment, strong multi-tasking, attention to detail
- Works with minimal supervision
- Effective technical writing; strong organizational, interpersonal, and communication skills
- Professional behavior and teamwork; embrace core values