Senior Manager, Quality Document Control and Compliance
Olema Oncology
5 months ago
On-site
Cambridge, MA
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 QDocs for GxP controlled documents
- Serve as Veeva Vault QDocs Administrator and document control manager
- Format finalized documents to ensure compliance with effective templates
- Proofread and finalize documents for final processing in Veeva QDocs
- Develop, update, manage, and maintain GxP controlled documents in coordination 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 troubleshooting
- Maintain document control compliance KPIs (periodic review) and compile/report metrics for management review
- Partner with IT on Veeva system change control (system process enhancements/improvements and new release validation)
- Serve as backup Veeva Quality Training Administrator and support creation of 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
- Experience establishing effective KPIs for a document management system
- Experience creating and facilitating training for Quality Systems
Skills / Attributes:
- Strong written and verbal communication and interpersonal skills
- Commitment to supporting internal/external teams and customers
- Autonomy and initiative
- Meticulous attention to detail and strong organization
- Ability to multi-task, shift priorities, work in a fast-paced environment, and solve problems
- Team player in a highly matrixed organization with professional demeanor, enthusiasm, and self-motivation
Location & Travel:
- San Francisco, CA or Cambridge, MA; ~15% travel
Compensation / Benefits:
- Base pay range: $150,000 - $160,000 annually (plus equity, bonus, and benefits)
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 QDocs for GxP controlled documents
- Serve as Veeva Vault QDocs Administrator and document control manager
- Format finalized documents to ensure compliance with effective templates
- Proofread and finalize documents for final processing in Veeva QDocs
- Develop, update, manage, and maintain GxP controlled documents in coordination 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 troubleshooting
- Maintain document control compliance KPIs (periodic review) and compile/report metrics for management review
- Partner with IT on Veeva system change control (system process enhancements/improvements and new release validation)
- Serve as backup Veeva Quality Training Administrator and support creation of 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
- Experience establishing effective KPIs for a document management system
- Experience creating and facilitating training for Quality Systems
Skills / Attributes:
- Strong written and verbal communication and interpersonal skills
- Commitment to supporting internal/external teams and customers
- Autonomy and initiative
- Meticulous attention to detail and strong organization
- Ability to multi-task, shift priorities, work in a fast-paced environment, and solve problems
- Team player in a highly matrixed organization with professional demeanor, enthusiasm, and self-motivation
Location & Travel:
- San Francisco, CA or Cambridge, MA; ~15% travel
Compensation / Benefits:
- Base pay range: $150,000 - $160,000 annually (plus equity, bonus, and benefits)