Manager, Quality Assurance

Job Description

Description:

The Manager, QA – Kentucky Distribution Center is responsible for overall Quality Assurance leadership and oversight of all quality systems, regulatory compliance activities, and quality operations within the Kentucky Distribution Center and Transportation operations. This position ensures that all distribution-related activities, including product receipt, inspection, storage, release, returns, recalls, transportation, environmental controls, and compliance programs, are performed in full compliance with cGMPs, FDA regulations, company Quality Manual requirements, and applicable regulatory standards. The role provides strategic direction, quality system governance, audit readiness leadership, and people management for the QA Distribution team.

Essential Functions:

• Quality System Oversight & Governance: Provides full QA oversight for distribution center operations, including product receipt, inspection, storage, handling, release, customer returns, recalls, HOLD/QUARANTINE inventory, and transportation quality.
• Ensures all distribution quality systems are compliant with FDA regulations, cGMPs, and corporate quality standards.
• Owns and maintains distribution center related SOPs and ensures alignment with corporate quality policies.
• Ensures effective management of environmental monitoring and pest control programs, including review, trending, documentation, and corrective action follow-up.
• Ensures regulatory licensing and facility registrations are reconciled, maintained, and compliant.
• Regulatory & Compliance Leadership Serves as the site QA representative for regulatory inspections, customer audits, and third-party audits related to distribution activities.
• Responsible for site QMS (Deviation, CAPA, Change Control), DMS (SOPs, Work instructions etc), Document Control, and LMS Ensures ongoing inspection readiness and leads remediation of audit findings, CAPAs, and compliance commitments.
• Maintains expert-level knowledge of current regulatory requirements and emerging trends impacting distribution and transportation compliance.
• Operational Quality Oversight: Reviews and approves quality documentation associated with product disposition, quarantine, release, returns, and recall activities.
• Oversees inventory status controls (HOLD/QUARANTINE/RELEASED/REJECT) and ensures discrepancies are investigated and resolved.
• Ensures proper documentation and execution of transportation quality requirements.
• Leadership & People Management: Directly supervises QA Distribution Associates both on site and Associates located at Amneal’s SETE office (India) Provides coaching, performance management, development planning, and succession planning for team members.
• Ensures adequate staffing, training, and competency within the QA Distribution function.
• Promotes a culture of quality, compliance, and continuous improvement.
• Training & Continuous Improvement: Ensures site-wide cGMP and distribution quality training programs are maintained and current.
• Identifies process improvement opportunities and drives enhancements to efficiency, compliance robustness, and risk mitigation.
• Leads periodic review of quality metrics and drives corrective and preventive actions where needed.
  
  
  

Additional Responsibilities:

• Leads internal audits of distribution center quality systems and ensures effective follow-up on findings.
• Oversees vendor qualification and performs external vendor audits related to distribution and transportation services.
• Participates in cross-functional quality initiatives and corporate quality programs.
• Supports quality risk assessments and change management activities impacting distribution operations.
• Performs other duties as assigned by QA leadership.
  
  
  

Qualifications

Education:

• Bachelors Degree (BA/BS) Life Sciences, Pharmacy, Engineering, or related field - Required
• Master Degree (MS/MA) Advanced Degree (Master's) - Preferred
  
  
  

Experience:

• 5 years or more in Experience in FDA regulated industry
• 2 years or more in Managerial Experience
  
  
  

Specialized Knowledge:

• Strong leadership and people management skills
• Excellent written and verbal communication skills
• Strong decision-making and risk assessment capabilities
• Ability to influence cross-functional stakeholders
• High level of integrity and discretion with confidential information
• Strong organizational and documentation skills
• Ability to manage multiple priorities in a regulated environment
• Strong analytical and problem-solving abilities
  
  
  

Licenses:

• -Upon Hire-Preferred