Manager, GxP Controlled Documents and Training

Location
Remote or Hayward , California
Posted
Mar 26, 2021
Ref
179
Discipline
Administration, Training
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

About us:

 

Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.

We are located in the San Francisco bay area, in the heart of the world’s largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the “rule book” has not yet been written.

 

Job Summary:

 

The Manager, GxP Controlled Documents and Training is responsible for managing document control and training in Arcus’s Quality System. This individual will maintain Arcus’s GxP Controlled Document (VVQD) process workflows and GxP Training in Veeva Vault Training. Individual should be familiar with standard GxP concepts, practices, and procedures to manage quality related documents and training.

 

Job Responsibilities:

 

Document Control/Quality Training Support:

 

  • Manage and maintain controlled documents and GxP training in VVQD/VVT
  • Provide first level support for end users across document control and training process.
  • Track controlled documents to ensure review and approval are completed within VVQD.
  • Edit and proofread controlled documents for consistency of document format and adherence to Arcus processes and procedures
  • Provide basic system training to all users and advanced training as needed.
  • Create training materials, including Quick Reference Guides and videos.
  • Author, revise and update controlled document and GxP training procedures as needed.
  • Serve as Controlled Document and GxP Training subject matter expert (SME) and oversee controlled document and training processes for new, revised, and archived documents/trainings ensuring compliance with Arcus controlled document procedures.
  • Review SOP/Work Instruction content and exercise judgements to provide suggestions to author to ensure alignment with Arcus’s controlled document procedures and best practices
  • Manage internal training program and coordinate and/or administer GxP training.
  • Provide support for DMS and LMS during internal audits, regulatory inspections, and strategic partner audits
  • Provide coaching and mentoring of junior staff
  • Other duties as assigned

 

Qualifications (including knowledge & skills):

 

  • Working knowledge of Microsoft Office and Adobe systems.
  • Requires strong written, oral, interpersonal and communication skills
  • Knowledge of document management systems and document formatting required
  • Knowledge of GxP concepts and guidelines

 

Education:

 

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

 

Experience:

 

  • 5+ years of R&D and pharmaceutical document control experience
  • 5+ years of experience in electronic document management
  • 3+ years in Quality Assurance
  • Experience in the preparation of documents using document management systems {e.g. Veeva Vault, Documentum, FirstDocs,) is highly desirable.