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HLD Compliance System Validation Assoc Manager

Newark Primary Location: 211 LAKE DRIVE , ALPHARETTA, GA - United States, 30005 Facility Newark Job ID 256097

The Healthcare Quality Assurance (QA) Validation Associate Manager plans and sets direction for the Validation team to maintain validation of facilities, chambers, and information technology systems utilized for healthcare applications. He/She performs and reviews assessments of facilities and systems using predetermined healthcare industry standards ensuring compliance with governmental regulations and UPS quality policies. The Healthcare QA Validation Associate Manager monitors the identification of facilities, chambers, and systems requiring validation, resolves validation issues, and provides validation expertise. He/She oversees the management of validation activities and documents and assists in determining applicable regulations and capabilities for validation purposes. He/She participates in client audits and regulatory agency inspections. The Healthcare QA Validation Associate Manager supports the implementation of new clients by providing direction and facilitates testing of new facilities, chambers, and systems. This position manages supervisors and specialists.

Responsibilities and Duties

  • Provides direction and facilitates testing of new healthcare facilities, chambers, and systems to cultivate successful and compliant implementations for new clients
  • Conducts management reviews to ensure validation issues are escalated appropriately and in a timely manner
  • Reviews and approves standard operating procedures and work instructions to ensure proper procedures are followed by Operations, Information Technology (IT), Plant Engineering (PE), and Order-to-Cash personnel
  • Interfaces with Corporate Compliance and evaluates procedures across locations to identify overlaps and gaps in procedures and guidelines and ensure consistency in content and implementation
  • Manages resources and people processes (e.g., Performance Management, Career Development, Training, Staffing, etc.) to ensure the day to day administration of processes and formal procedures
  • Identifies individual and team skill gaps and developmental opportunities (e.g., training, special assignments, conferences, projects, etc.) to facilitate individual and team development
  • Coordinates and responds to Corporate Compliance audits to take corrective and preventive action, track and trend audit findings, and maintain proof of audits and documentation
  • Conducts pre-audits to ensure agenda information is in compliance with the requirements and specifications
  • Consults with internal groups (e.g., Operations, Business Development, IT, PE, etc.) to investigate and resolve healthcare issues regarding compliance and regulations
  • Monitors agency and client follow-up after inspections and discovery of internal issues to meet respective agency requirements in a timely manner

Knowledge and Skills

  • Identifies the business problem that requires research; identifies sources of information that are relevant to a problem; reviews literature and data related to the research question; summarizes information from data sources
  • Applies knowledge of agencies' functions and regulations to compliance and enforcement activities; identifies routine situations where the organization may be out of compliance as well as the specific impacts of non-compliance
  • Tests new products, solutions, services, or technology to ensure developed components meet design requirements; designs in-depth testing plans; balances quality of components with time and cost constraints
  • Identifies and evaluates risks; determines and applies appropriate risk treatment(s)
  • Demonstrates a basic understanding of supply chain concepts; identifies issues within a supply chain
  • Recognizes the basic impact of technology on UPS business, services, and processes; identifies technological barriers in achieving desired objectives; maintains appropriate breadth and depth of technological knowledge for current work assignment
  • Bachelor's Degree in Computer Science or Science related field - Preferred
  • Healthcare Industry experience - Preferred

UPS is an equal opportunity employer. UPS does not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity or any other characteristic protected by law
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