Senior Manager, Quality Document Control and Compliance
Olema Oncology
5 months ago
On-site
San Francisco, CA
Operations
Senior Manager, Quality Document Control and Compliance
Responsibilities:
- Lead and manage the daily activities of Veeva Vault QDocs and overall document management process and compliance
- Create and process document change control (DCC) documentation in Veeva for GxP controlled documents
- Serve as Veeva Vault QDocs Administrator and document control manager
- Format finalized documents to ensure compliance with effective templates
- Perform proofreading and finalize documents for final processing in Veeva QDocs
- Develop, update, manage, and maintain GxP controlled documents with functional area representatives
- Develop SOPs and work instructions (WIs) to support Quality Systems and Veeva document control processes
- Assist and train end users in Veeva to execute document review, approval, and troubleshoot as needed
- Maintain document control compliance KPIs (periodic review) and compile/report metrics for management review
- Partner with IT on Veeva system change control (process enhancements/improvements and new release validation)
- Serve as backup Veeva Quality Training Administrator and support training assignments as needed
- Perform other duties and complete special projects as required
Qualifications / Requirements:
- Bachelor’s Degree required
- Experience managing and maintaining GxP compliance documents and document control systems
- Strong knowledge of GxP/FDA regulations and experience supporting regulatory inspections
- 8+ years of industry experience
- 2+ years as Veeva Vault QDocs Administrator
Preferred / Additional:
- Experience establishing effective KPIs for document management systems
- Experience creating and facilitating training for Quality Systems
Skills / Attributes:
- Strong written and verbal communication and interpersonal skills
- Autonomy and initiative
- Meticulous attention to detail and strong organization
- Ability to multitask, shift priorities, and solve problems in a fast-paced environment
- Ability to collaborate effectively in a highly matrixed organization
Compensation/Benefits:
- Base pay range: $150,000–$160,000 annually (plus equity, bonus, and benefits)
Location/Travel:
- San Francisco, CA or Cambridge, MA; ~15% travel
Responsibilities:
- Lead and manage the daily activities of Veeva Vault QDocs and overall document management process and compliance
- Create and process document change control (DCC) documentation in Veeva for GxP controlled documents
- Serve as Veeva Vault QDocs Administrator and document control manager
- Format finalized documents to ensure compliance with effective templates
- Perform proofreading and finalize documents for final processing in Veeva QDocs
- Develop, update, manage, and maintain GxP controlled documents with functional area representatives
- Develop SOPs and work instructions (WIs) to support Quality Systems and Veeva document control processes
- Assist and train end users in Veeva to execute document review, approval, and troubleshoot as needed
- Maintain document control compliance KPIs (periodic review) and compile/report metrics for management review
- Partner with IT on Veeva system change control (process enhancements/improvements and new release validation)
- Serve as backup Veeva Quality Training Administrator and support training assignments as needed
- Perform other duties and complete special projects as required
Qualifications / Requirements:
- Bachelor’s Degree required
- Experience managing and maintaining GxP compliance documents and document control systems
- Strong knowledge of GxP/FDA regulations and experience supporting regulatory inspections
- 8+ years of industry experience
- 2+ years as Veeva Vault QDocs Administrator
Preferred / Additional:
- Experience establishing effective KPIs for document management systems
- Experience creating and facilitating training for Quality Systems
Skills / Attributes:
- Strong written and verbal communication and interpersonal skills
- Autonomy and initiative
- Meticulous attention to detail and strong organization
- Ability to multitask, shift priorities, and solve problems in a fast-paced environment
- Ability to collaborate effectively in a highly matrixed organization
Compensation/Benefits:
- Base pay range: $150,000–$160,000 annually (plus equity, bonus, and benefits)
Location/Travel:
- San Francisco, CA or Cambridge, MA; ~15% travel