Senior Manager, Quality Document Control and Compliance

Olema Oncology•Boston, MA

8h•$150,000 - $160,000•Onsite

About The Position

The Senior Manager, Quality Document Control and Compliance will report to the Director, Quality Systems and lead and manage the daily activities of Veeva Vault QDocs and overall document management process and compliance. This role includes but not limited to: creation and processing of document change control documentation in Veeva QDocs, management of standard operating procedures (SOPs) and other GXP documentation, GXP record processing and archival, maintain document control compliance KPIs and compile and report metrics for management review. This role is based out of our San Francisco, CA or Cambridge, MA office and will require about 15% travel.

Requirements

Bachelor’s Degree is required
Experience in managing and maintaining GxP compliance documents and Document Control systems
Strong knowledge of GxP/FDA regulations and experience in supporting regulatory inspections
8+ years of industry experience
2+ years as Veeva Vault QDocs Administrator
Experience in managing and maintaining GxP documents and Document Control systems
Experience establishing effective KPIs for document management system
Experience creating and facilitating training for Quality Systems
Strong written and verbal communication and interpersonal skills
Commitment to supporting internal and external teams and customers
Demonstrates strong autonomy and initiative
Meticulous attention to detail and well organized
Ability to multi-task, shift priorities, work in a fast-paced environment, and adeptly solve problems
Effectively collaborate as a team player in a highly matrixed organization, demonstrating professional demeanor, enthusiasm, and self-motivation

Responsibilities

Serving as Veeva Vault QDocs Administrator and document control manager
Processing document change control (DCC) in Veeva for GxP controlled documents
Formatting the finalized documents to ensure compliance with effective templates
Performing proof reading and finalize document for final processing in Veeva QDocs
Developing, updating, managing, and maintaining GxP controlled documents in close cooperation with functional area representatives
Developing SOPs and WIs to support Quality Systems and Veeva Document control processes
Assisting and training end users in Veeva to execute document review, approval and troubleshoot as needed
Maintaining document control compliance KPIs such as periodic review and compiling and reporting metrics for management review.
Partnering with IT to support Veeva system change control activities for system process enhancements/improvements and new release validation.
Serving as backup Veeva Quality Training Administrator and supporting creation of training assignments as needed
Performing other duties and complete special projects as required