Senior Manager Quality Assurance

The Senior Manager, Computer Systems Quality job oversees aspects of the Quality Management System (QMS) at Emmes and manages staff within the QA Department. Manager works with QA, company, and project leadership to ensure adherence to applicable regulations, industry standards, and project requirements.

• • Manages the quality support for computer system validation activities for Emmes’ proprietary, Veridix AI, and commercial off-the-shelf (COTS) software systems used in clinical trials.
  • Leads review and audits of computer systems verification and validation processes to identify potential gaps and non-compliance.
  • Ensures the review of validation documentation for computerized systems and applications.
  • Manages deviations and CAPAs related to computerized systems
  • Manages one of multiple components of Emmes’ Quality Management System

  (e.g., internal auditing program, document control, CAPA program, etc.)

  • Supervises QA Department staff
  • Drafts and reviews QA policies and procedures
  • Reviews and approves audit reports
  • Creates audit schedules
  • Analyzes quality data for improvements in the QMS
  • Leads process improvement activities
  • Leads client audits and regulatory inspections
  • Prepares reports for QA management and internal leaders
  • Provides corporate training and guidance as needed
  • Other duties as assigned

• Bachelor’s degree in Life Sciences or a related scientific field
• Ten (10) years experience working in a regulated environment (e.g., GCP, GLP, GMP, ISO), to include management experience
• Advanced knowledge and understanding of 21CFR Part 11/EU Annex 11, GAMP 5, and related industry standards required with familiarity with security regulations such as NIST SP 800-53 and FISMA preferred.
• CQA, CCRP, ISO certification (or equivalent) preferred