Senior Quality Operations Specialist

About the role

Reporting to the Director of Operations Quality, the Senior Quality Operations Specialist operates as a key contributor—both independently and through project teams—to embed quality culture, reduce compliance risk, identify efficiencies, drive continuous improvement, and achieve business results. The role ensures that processes, procedures, people, analytics and technology are leveraged to maximize quality processes and compliance across the network. It provides direction during high-risk and critical events that may impact product by applying experience and judgment within defined policies, and influences investigation quality standards, documentation rigor, and work prioritization to promote consistent application of internal procedures and applicable regulatory requirements. The Senior Quality Operations Specialist also supports the Director Operations Quality in maintaining the effectiveness of USPD’s Quality Management System (QMS) in accordance with internal policies and applicable laws and regulations, including preparedness for emerging regulatory and operational changes. This is an onsite role located in Shepherdsville, KY (i.e., the Clermont Specialty DC).

Responsibilities

• Operations Quality Support and Collaboration
  • Serve as the primary Quality liaison to Operations at the Clermont DC
  • Maintain a regular onsite presence to foster a culture of quality, compliance and collaboration
  • Partner with cross‑functional stakeholders to address operational quality needs and risks
  • Promptly escalate critical events while planning the investigative approach based on event risk, urgency, resource availability, and potential business impact
  • Oversee critical investigation execution, coordinating cross‑functional input as needed to support timely and effective resolution
• Quality System Execution and Oversight
  • Drive expectations for quality at the Distribution Center (DC), including creating, reviewing and/or editing Standard Operating Procedures (SOPs) and Work Instructions (WIs) to enhance operational efficiency and compliance with corporate policies and regulations
  • Ensure operational compliance with DSCSA and implementation of National Standards
  • Support the administration and completion of operational investigations, coaching teams on root cause analysis tools and the appropriate development and implementation of CAPAs to ensure regulatory defensibility
  • Translate investigation data, trends, and business drivers into actionable recommendations that improve investigation outcomes and inspection readiness
  • Identify operational pain points and emerging risks and translate them into system or procedural improvements while maintaining operational efficiency
• Technical Resource Role
  • Serve as the Subject Matter Expert (SME) in:
    • Documentation Management / Version Control / Good Documentation Practices
    • Change Control
    • Investigations / Root Cause Analysis
    • Corrective and Preventive Actions (CAPAs)
    • Regulatory Inspection Management
    • Validation
    • Electronic Quality Management Systems (e.g., TrackWise and MasterControl)
    • Data Integrity
• Quality Leadership, Coaching & Knowledge Development
  • Partner with the site Director of Operations to support training delivery to enhance Operations’ understanding and application of Quality principles and requirements
  • Act as a technical and process expert for less‑experienced colleagues, providing guidance during critical events and offering direction as appropriate without formal people‑management responsibility
• Audit and Inspection Readiness
  • Support Operations to ensure continuous audit and inspection readiness
  • Assist with inspection preparation activities and post‑inspection responses as assigned
  • Participate in and support regulatory inspections, supplier/customer audits, and internal assessments as needed

Requirements

• Degree or equivalent and typically requires 7+ years of relevant experience
• Bachelor’s degree in a scientific, technical, or quality‑related field; advanced degree preferred

Critical Skills

• 7+ years of progressive experience in pharmaceutical / medical device quality, or regulated distribution environments
• Knowledge of cGMPs and Good Distribution Practices with a minimum of 3 years in a Quality Assurance role
• Experience working in a large, matrixed organization with cross‑functional exposure to Quality, Operations, Compliance, Technology, and external partners
• Ability to conduct complex initiatives in a self‑directed manner, with minimal oversight, and to deliver superior results in a timely manner
• Excellent written and verbal communication skills to effectively communicate and influence a broad spectrum of business segment personnel and senior management
• Superior level of professionalism to work effectively with internal and external personnel
• Excellent decision‑making and judgment capability
• Ability to influence without formal authority
• Ability to follow established procedures and instructions

Specialized Knowledge & Skills

• Knowledge of FDA regulations and requirements applicable to pharmaceutical distribution, including the Code of Federal Regulations (21 CFR), Drug Supply Chain Security Act (DSCSA), and industry standards for temperature excursion management (e.g., USP, USP)
• Experience working in pharmaceutical or medical device manufacturing
• Demonstrates analytical, problem‑solving, and decision‑making skills, including interpretation of data and regulatory standards to support sound and regulatory‑defensible conclusions
• Experience contributing to CAPA development and execution, quality system enhancements, inspection readiness activities, and execution of regulatory‑aligned investigation and documentation practices
• Practical expertise working within an electronic Quality Management System (eQMS), including supporting investigation workflows, documentation standards, user enablement, and data integrity
• Excellent prioritization skills to manage complex investigations and quality initiatives within a regulated environment

Pay

Target salary for this role is between $128,000 and $130,000 along with a 20% bonus.

Schedule

• Routine onsite presence required in an office and distribution center environment
• Interaction with warehouse operations as needed to support quality activities
• Ability to travel domestically overnight 20% of the time

Working Conditions

• General office requirements, including extended periods of computer and keyboard use
• Access to warehouse environment and activities as needed
• Ability to attend virtual meetings and training sessions
• Ability to work in refrigerated environments for short periods of time to support quality activities