QA Manager Systems and Process

Target PR Range: 56-68/hr DOE

QA Manager Systems and Process is responsible for oversight, support, and administration of Computer System Validation (CSV) and Data Integrity, assuring effective and efficient process maintenance to support GxP functions.

Primary role is supporting end users, Business Owners (BOs), Systems Owners (SO and QA, assuring applicable requirements are in place and met, system compliance, managing accounts, evaluating and managing CSV/DI and related changes, deviations and CAPAs, executing on continuous system improvements, and supporting Quality Management Systems (QMS) activities, as applicable.

• Analyze user enhancement requests to deliver solutions that establish and improve business processes, assuring process and system efficiency, elimination of process gaps, enabling automation
• Assemble document user and functional requirements
• Author and execute implementation plans, develop solutions, effectively manage timelines for timely execution
• Perform User Acceptance testing (UAT), Performance Qualification (PQ), Validation testing
• Create and run reports; track follow-up actions to ensure data quality and compliance
• Generate metrics to support business goals, as applicable
• Pro-actively improve monitoring, eliminate user issues, deliver better value to cross-functional teams
• Drive CSV/DI and QMS results, timeliness and compliance in QA, across System and Business Owners, and in cross-functional project forums
• Escalate timely and effectively

• Manage system access and permissions
• Perform QMS activities (changes, deviations, tracking, etc.)
• Design solutions; manage configuration
• Work proactively with users to resolve issues and drive timelines
• Create reports based on defined requirements
• Maintain system documentation and associated records
• Create and run reports; track follow-up actions, ensure data quality and compliance
• Review/approve validation deliverables (URS, FS, IQ/OQ/PQ, etc.)
• Identify, mitigate, escalat e and resolve issues and risks
• Author/review CSV, DI records, and QMS records, as applicable (policies, procedures, lifecycle documents)
• Generate metrics to support business goals as requested
• Maintain end-user support information
• Revise business guidance and user reference documentation
• Support internal and external audits/inspections
• Support CSV/DI program

• None

• Bachelor’s degree in science or related field and a minimum of 7 years of related experience; or,
• Equivalent combination of education and experience.

• At least 5 years of experience with validated applications in a pharmaceutical or regulated environment.
• Experience and knowledge of the quality and regulatory business processes.
• Direct hands-on experience implementing GxP computerized systems and maintaining validated state, and DI.
• Result driven
• Strong process improvement and negotiation skills, driving process excellence.
• Proven business and technology skills, successful in providing customer- oriented technology solutions.
• Proven excellent communication skills, with users, technical communities, cross-functional project groups. Communicates ideas in technical and user-friendly language.
• Collaborative team player, driving for results and timeliness.

• Knowledge of System Administration (Veeva Platform (Quality QMS, Quality QDocs));
  SaaS systems;
  Other Regulated Applications (Learning Management Systems, QMS)
• Knowledge of databases and computer networking
• Excellent communication skills (oral, written, presentations)

Environment:
Onsite