Senior Manager, Quality Document Control and Compliance
Olema Oncology
5 months ago
On-site
Boston, MA
Operations
Senior Manager, Quality Document Control and Compliance
Responsibilities:
- Lead and manage 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
- Manage standard operating procedures (SOPs) and other GxP documentation
- Perform GxP record processing and archival
- 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 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 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 assignment creation as needed
Qualifications (Knowledge/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
Experience:
- 8+ years of industry experience
- 2+ years as Veeva Vault QDocs Administrator
- Experience establishing effective KPIs for document management systems
- Experience creating/facilitating training for Quality Systems
Skills/Attributes:
- Strong written and verbal communication and interpersonal skills
- Autonomy and initiative; meticulous attention to detail; strong organization
- Ability to multitask, shift priorities in a fast-paced environment, and solve problems
- Ability to collaborate effectively in a highly matrixed organization
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)
Application instructions:
- Olema doesn’t accept agency resumes; not responsible for fees related to unsolicited resumes.
Responsibilities:
- Lead and manage 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
- Manage standard operating procedures (SOPs) and other GxP documentation
- Perform GxP record processing and archival
- 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 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 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 assignment creation as needed
Qualifications (Knowledge/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
Experience:
- 8+ years of industry experience
- 2+ years as Veeva Vault QDocs Administrator
- Experience establishing effective KPIs for document management systems
- Experience creating/facilitating training for Quality Systems
Skills/Attributes:
- Strong written and verbal communication and interpersonal skills
- Autonomy and initiative; meticulous attention to detail; strong organization
- Ability to multitask, shift priorities in a fast-paced environment, and solve problems
- Ability to collaborate effectively in a highly matrixed organization
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)
Application instructions:
- Olema doesn’t accept agency resumes; not responsible for fees related to unsolicited resumes.