Health Care Validation Supervisor

Job Summary

The Healthcare Quality Assurance (QA) Validation Supervisor provides guidance to Operations or Information Technology [IT] to maintain validation of facilities, chambers, or systems utilized for healthcare applications. He/She assesses facilities or systems being evaluated for use in healthcare applications and provides training and subject matter expertise to achieve and maintain validated status. This position identifies facilities, chambers or systems requiring validation, elevates validation issues appropriately, and provides validation expertise. He/She manages validation documents, determines applicable regulations and capabilities for transporting clients' healthcare products, and supports audits and inspections. The Healthcare Quality Assurance Validation Supervisor reports to the manager.

Job Duties

• Identifies facilities, chambers or systems requiring validation (i.e., reliable proof systems and equipment perform to defined specifications) to develop validation plans and documents.
• Participates in management reviews to ensure validation issues are elevated appropriately.
• Develops and revises change control procedures, training, and audits to ensure the maintenance of validation.
• Writes and executes validation protocols, generates validation reports, and performs corrective actions for deviations to provide subject matter expertise for Supply Chain Solutions (SCS) in validation matters.
• Establishes and maintains audit programs for validated facilities, chambers or systems to create synergies and consistency.
• Consults with internal groups ( e.g., Operations, Business Development, Information Technology, etc.) and investigates and resolves healthcare issues to ensure compliance with rules and regulations.
• Reviews policies, procedures, and regulations with clients to determine specialized requirements and ensure compliance.
• Interfaces with client QA departments and attends sales presentations and business reviews to support the coordination of client activities.
• Participates in regulatory agency interactions to interpret rules and regulations.
• Assists in agency follow-ups after inspections and discovery of internal issues to meet respective agency requirements.
• Follows up with clients after audits to identify issues and mutually acceptable solutions.
• Writes and revises standard operating procedures (SOPs) and work instructions to ensure proper procedures are followed by Operations, IT or Order-to-Cash personnel.
• Coordinates document and data control (e.g., numbering, version control, controlled copies, etc.) to ensure documentation and data are maintained in an orderly manner and meet quality standards.
• Implements training programs and materials to train QA and internal clients on SOPs, work instructions, and regulatory topics.
• Helps interface with Corporate Compliance and evaluates procedures across locations to ensure no overlaps and gaps in procedures and guidelines and consistency in content and implementation exist.
• Establishes and maintains quality policies and programs within the IT area to ensure proper document and data control methods are utilized.
• Participates in information gathering and scheduling to prepare for internal and client audits.
• Records information and observations from internal audits to support the preparation and distribution of internal audit reports.
• Interacts with internal auditors to discuss audit plans and findings.
• Hosts and responds to corporate compliance audits to take corrective and preventative action, track and trend audit findings, and maintain proof of audits and documentation.
• Hosts and responds to regulatory agency inspections to identify and conduct follow-up activities.
• Identifies client product types and requested service requirements (e.g., storage, etc.) to determine applicable regulations.
• Assess current Supply Chain Solutions (SCS) capabilities to determine SCS's ability to meet client requirements and proposed solutions.
• Assists in establishing and completing risk assessment procedures and processes to support risk minimization.
• Participates in consultations with Corporate Legal to determine compliance implications of pending business.
• Communicates with Contracts, BD, and Solutions to support consultation on potential business opportunities.

Basic Qualifications:

• Bachelor's degree - Science preferred or equivalent Business experience.
• Experience in a FDA/DEA related business is required.
• Applicants must be legally authorized to work in the United States.