Skip to main content

This job has expired

You will need to login before you can apply for a job.

Senior Manager, Regulated Systems (Remote)

Employer
Arcus Biosciences, Inc.
Location
Remote
Start date
Apr 25, 2022

View more

Discipline
Regulatory, Regulatory Affairs, Research/Documentation
Required Education
Bachelors Degree
Position Type
Full time

Summary

The Senior Manager, Regulatory Systems is responsible for optimizing efficiency, return on investment and user adoption of critical internal systems to support GxP processes, including the Veeva Vault Suite of products. The position will lead a team that guides and supports Regulatory Affairs and Operations, Quality and Clinical teams in their systems usage. The Senior Manager, Regulated Systems will partner internally with the Technology team to implement any proposed system updates and externally with relevant system vendors to ensure that enhancements critical to Arcus business needs are included in future releases of the software products. This position will be responsible for assessing software product releases for Arcus adoption, updating business process documentation and training the relevant business user teams. At regular intervals, this role will define, track and report important KPIs and metrics to demonstrate the value these systems bring to the organization. 

Responsibilities

  • Establish and define processes for centralized system support for business users.
  • Define and track key performance indicators and system use metrics to demonstrate return on investment for regulated systems.
  • Establish just-in-time training for business users at the start of key projects (e.g. new regulatory submission, new clinical trial).
  • Build and manage a team of system specialists to align with business needs and provide first level support for users across the enterprise, initially for the Veeva Vault suite of products, but this may be extended to cover additional systems as the organization grows.
  • Define and lead a cross-Vault governance board to align platform level process and procedures
  • Own training materials, best practices and procedures in relation to system functions.
  • Advocate on behalf of Arcus business users with software vendors to continue to optimize the systems and therefore Arcus processes.
  • Be aware of new and emerging technologies to streamline business processes.
  • Own validation processes for updates and new releases of system functionality to ensure all regulated systems are validated in accordance with Arcus policies and procedures.
  • Partner with Arcus technology team to define and document system changes, appropriate change control documentation and validation of changes. 

Qualifications 

  • Proficient in Microsoft Office, especially Word, PowerPoint and Excel
  • Knowledge of regulated systems required, e.g. document management, data management, publishing. Knowledge of Veeva Vault eTMF, QualityDocs and RIM preferred.
  • Thorough understanding of computer systems, databases and experience with system maintenance and the software development lifecycle [SDLC].
  • Understanding and experience with software validation process and electronic records, electronic signatures (ERES) processes for US, EU and other major markets.
  • Ability to convey complex technical processes in a simple manner to all levels of the user community 

Education

  • Bachelor's degree or related experience is required. Computer science field a plus. 

Experience

  • 5+ years experience in systems management or implementation in the life sciences industry or
  • regulated industry
  • Experience in the implementation and configuration of regulated systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools)
#LI-EW1
#LI-Remote
Arcus is an EEO

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert