Quality Operations Program Manager - Document Control

• Act as subject matter expert for the Document Control process area by owning the lifecycle management of quality processes and records
• Serve as System Administrator of Veeva’s internal electronic Document Management System (eDMS), responsible for system configuration, user administration, lifecycle management, and continuous improvement of the system and its governed processes
• Provide quality oversight on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in scope products and systems
• Provide technical expertise, regulatory interpretation, and direction regarding federal regulations, and other quality system requirements
• Develop appropriate metrics and track effectiveness and productivity of applicable domain systems

• BS/BA in Science, Information Management, Engineering, related disciplines or equivalent industry experience
• 5+ years experience in a regulated quality role in Life Sciences
• Experience with Quality Management Systems (e.g., documentation and record management, training, change control, CAPA)
• Experience with electronic Document Management Systems (eDMS) and/or electronic Quality Management Systems (eQMS)
• Good understanding of GxP (GMP, GCP, etc.) regulations, principles of quality management systems in a regulated environment (21CFR 11, ICH Q10, QSR) and/or quality frameworks such as ISO9001
• Excellent process mapping, problem-solving, and communication skills to effectively convey technical and regulatory concepts

• Direct, hands-on experience utilizing or administering Veeva Quality Cloud solutions (e.g., Veeva QualityDocs, QMS, or Training)
• Solid foundation in Quality Principles and Standards used in the design, development, testing, and maintenance of software in a regulated environment (e.g., ISO, IEC, IEEE, ITIL, ICH)
• Understanding of the software development cycle (SDLC) and computer systems validation (CSV)

We value your time and believe in a transparent hiring process. Here is the process you can expect.

• Follow the application process and submit your resume.
• Within 3 days, you will receive a link to a personality assessment administered by a third party.
• Once you complete the assessment, our team will review your full application package and follow up via email with our decision.
• If moving to the interview stage, the process is as follows:
  1. A conversation with the hiring manager
  2. A practical case exercise
  3. A final conversation with our group's Senior Leader.
• Once all interviews are complete, the manager will be in touch with a final decision.

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