Healthcare Quality Assurance Manager

Role Overview

• Communicates and manages quality policy and objectives
• Reports on the overall effectiveness of the UPS Healthcare quality program
• Develops, manages and supports people resources and processes
• Ensures direct and indirect reports have documented career goals
• Conducts frequent performance evaluations in a consistent, fair and objective manner
• Delivers training
• Identifies individual and team skill gaps and developmental opportunities
• Holds others accountable to established performance levels to achieve individual and group goals
• Resolves individual and group performance issues
• Coaches others and provides on-going feedback and support to improve performance
• Identifies opportunities to involve others in new and challenging work assignments or rotations that advance the skills of the individual
• Makes salary recommendations to reward employee performance
• Manages staffing levels and manages resource needs in order to meet the business demand
• Manages risk assessment & risk minimization of storage, distribution and transportation of healthcare products
• Manages and conducts assessments of current SCS capabilities
• Manages licensing and RA appropriate risk assessment procedures and processes to minimize risk
• Conducts consultations with Corporate Legal to determine compliance implications of pending business opportunities
• Assesses risk and develops corrective and preventive actions (CAPA) to close identified gaps or concerns
• Manages information gathering, scheduling, preparation and distribution of reports to prepare for internal and client audits
• Reviews and approves audit response to findings
• Manages audit response timeliness
• Ensures that action items from AIPs are completed on time
• Manages change controls, training, PACs, audits, audit responses and the writing and revising of procedures identified as needed
• Creates, revises, reviews and approves controlled documents and record templates
• Supports growth of new and expanded facilities, clients and services
• Supports continuous quality management system improvements
• Reviews and approves major and critical nonconformance reports
• Evaluates and manages procedures across locations to ensure consistency in content and implementation
• Analyzes information on incidents to determine causes and document findings
• Identifies patterns or trends among incidents to determine next steps required by type of incident

Requirements

• Possess at least a Bachelor’s degree in a Science-related discipline
• Possess 5 to 7 years’ experience in pharmaceutical or healthcare industry in a quality related role
• Possess strong technical quality and regulatory affairs (QA/RA) knowledge
• Prior experience with GMP and/or GDP guidelines
• Prior experience with ISO 13485 and 9001 standards
• Demonstrate superior people management with prior experience in past roles
• Demonstrates a detailed understanding of supply chain concept
• Display superior attention to detail
• Display positive leadership, influence and negotiation skills
• Possess strong written and verbal communications skills
• Proficient in Microsoft Office applications (Word, PowerPoint, Excel)

Benefits

• Health insurance
• 401(k) matching
• Flexible working hours
• Paid time off
• Remote work options