Quality Assurance Manager

Life Science Logistics • Brownsburg, IN

15d

About The Position

The Quality Assurance Manager oversees quality and regulatory compliance across all 3PL operations, maintaining inspection readiness and leading or supporting regulatory inspections, client audits, internal audits, and supplier/vendor qualification. The role exercises quality authority to quarantine, hold, and release product and ensures regulatory and client quality requirements are met.

The manager oversees and continuously improves the Quality Management System, including deviations and nonconformances, CAPA, change control, document control, record retention, GMP training, complaints, returns, recalls, and temperature excursions. The role ensures thorough investigations, effective corrective actions, data integrity, and compliance in eQMS, LIMS, and other GxP systems.

The position provides quality oversight of cleanroom sampling and dispensing, as well as the environmental monitoring program. It leads quality improvement initiatives, analyzes trends and KPIs, and reports quality performance at management review. The manager serves as the primary quality contact for commercial clients and leads, coaches, and develops QA personnel, including the Sampling and Dispensing Supervisor. Work is primarily in an office, with regular time in warehouse and cleanroom areas as needed.

Requirements

• Bachelor’s degree in Biology, Chemistry, Engineering, or a related field; equivalent experience may be considered.
• At least 5 years of quality experience in the pharmaceutical, medical device, or another FDA-regulated industry.
• At least 3 years of supervisory experience.
• Working knowledge of state and federal laws and regulations governing warehousing and distribution of pharmaceuticals and medical devices, including FDA, DEA, PDMA, and DSCSA, and the ability to interpret and apply them.
• Excellent verbal and written communication and presentation skills.
• Strong analytical skills, including investigation, root-cause analysis, and trending and presentation of quality metrics.
• Sound critical thinking and attention to detail.
• Strong organization and time-management skills, with the ability to prioritize in a fast-paced environment.
• Ability to learn and use quality and warehouse management systems, including eQMS, LIMS, Tecsys Elite, and WebCTRL; training is provided.
• Proficiency in Microsoft Outlook, Excel, Word, and PowerPoint.
• Ability to analyze data, manage multiple priorities, make timely decisions, and communicate effectively under deadlines.
• Ability to read documents, screens, and labels and visually inspect materials and records.
• Ability to perform light to medium work involving frequent walking and standing, periods of sitting, occasional lifting of up to 50 lbs, and gowning and wearing PPE for cleanroom entry.
• Must have a valid driver’s license and be able to travel up to 15%.
• Must successfully pass preliminary employment requirements, such as a background check and drug screen.

Nice To Haves

• Experience in 3PL, warehouse, or distribution quality operations.
• Experience with cleanroom operations, sampling and dispensing, and environmental monitoring.
• Experience hosting regulatory inspections and client audits.
• ASQ certification (e.g., CQA, CQM/OE, CPGP) and/or ISO auditor certification.

Responsibilities

• Ensure compliance with FDA regulations, cGMP, DEA, DSCSA, applicable state licensing requirements, and client-specific quality requirements across 3PL operations.
• Maintain inspection readiness for internal, client, and regulatory audits; lead and support inspections and audits; ensure timely, complete responses to observations and follow-through on commitments.
• Support the internal audit (self-inspection) program and supplier/vendor qualification activities.
• Oversee and continuously improve QMS processes covering deviations and nonconformances, CAPA and effectiveness checks, change control, document control, record retention, GMP training, complaints, returns, recalls, and temperature excursions.
• Ensure investigations identify root causes and corrective actions are effective and sustainable.
• Ensure data integrity and electronic record compliance in eQMS, LIMS, and other GxP systems.
• Exercise quality authority to quarantine, hold, and release product according to approved procedures.
• Provide quality oversight of cleanroom sampling and dispensing, including adherence to SOPs, cGMP, and aseptic practices; review records, labeling, chain of custody, and line clearance; and investigate related deviations.
• Oversee the cleanroom environmental monitoring program, including data review and trending, excursion investigations and CAPA, and cleanroom qualification, cleaning/disinfection, and monitoring requirements.
• Lead initiatives to improve quality performance, reduce variation and deviations, and increase Right-First-Time execution and operational efficiency.
• Analyze quality trends, metrics, and KPIs to identify systemic issues and support data-based decisions; report performance and improvement actions at management review.
• Serve as primary quality contact for commercial clients; address client concerns and quality events; meet client notification requirements; and support quality agreement development, maintenance, and compliance.
• Lead, coach, and develop QA professionals, including the Sampling and Dispensing Supervisor; establish expectations; and participate in hiring, performance reviews, and development planning.
• Promote accountability, ownership, and quality excellence across the organization.
• Perform other duties as assigned.
• Travel up to 15%.
• Successfully pass preliminary employment requirements, such as a background check and drug screen; maintain a valid driver’s license.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager