Quality Assurance Manager

Quality Manager overseeing GxP/QA operations for pharmaceutical/life-science warehousing and distribution at the Whiteland, Indiana facility.

About the Role

Core responsibilities include leading the Quality Assurance/Quality Unit and serving as the primary quality authority for warehouse/distribution operations.

Responsibilities

• Develop and maintain quality strategy, policies, SOPs/work instructions, processes, and quality culture.
• Interpret and apply GxP regulations to operational and compliance issues.
• Manage internal/external audits, regulatory inspections, assessments, CAPAs, investigations, and non-compliance issues.
• Own quality metrics/KPIs and provide quarterly quality performance reporting to leadership.
• Act as the primary quality contact for pharmaceutical clients/customers, including QBRs and quality requests.
• Monitor CQA (Critical Quality Attributes) and CPP (Critical Process Parameters) and recommend improvements.
• Lead risk management, quality projects, and GxP-related change initiatives.
• Partner with Operations to manage resources, priorities, schedules, and quality objectives.
• Develop and train warehouse personnel on GxP, GDP, compliance, and quality requirements.
• Manage/mentor Quality personnel and lead cross-functional/matrix teams.
• Support regulatory agency interactions and ensure client and regulatory requirements are met.
• Identify regulatory/business changes and assess their impact on warehouse quality.

Qualifications

• 7–10 years of pharmaceutical/life-sciences quality operations experience.
• Bachelor's degree in Biochemistry, Chemistry, Biology, or STEM preferred.

Required Skills

• Strong experience with:
• GxP / GMP / GDP
• Pharmaceutical distribution / 3PL / warehouse operations
• Quality Assurance / Quality Management
• Audits and regulatory inspections
• CAPA, deviations, investigations
• SOPs / quality systems
• Training / LMS
• Quality metrics and reporting
• Leadership experience managing QA personnel or cross-functional teams.