Quality Assurance Manager

LifeScience Logistics • Brownsburg, IN

6d

About The Position

The Quality Assurance Manager oversees quality operations across 3PL activities, ensuring compliance with applicable FDA, cGMP, DEA, DSCSA, state licensing, and client-specific requirements. The role maintains inspection readiness; leads or supports audits and inspections; and oversees the quality management system, including deviations, CAPAs, change control, document control, training, complaints, returns, recalls, and temperature excursions. The manager ensures robust investigations, effective corrective actions, data integrity, and appropriate quality decisions regarding product quarantine, holds, and release.

The position provides quality oversight of cleanroom sampling and dispensing and the environmental monitoring program. It reviews operational records and monitoring data, ensures adherence to procedures and aseptic practices, and oversees investigation and resolution of related quality events. The manager leads continuous-improvement efforts, monitors quality trends and KPIs, reports performance to management, and serves as the primary quality contact for commercial clients.

The role leads and develops QA personnel, including the Sampling and Dispensing Supervisor, and fosters accountability and quality excellence. Additional requirements include successfully completing preliminary employment checks, travel of up to 15%, and a valid driver’s license. Work is primarily office-based, 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 pharmaceutical and medical-device warehousing and distribution, 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 skills 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.
• Successfully pass preliminary employment requirements, such as a background check and drug screen.
• Ability to travel up to 15%.
• Valid driver’s license.
• Ability to perform light-to-medium work involving frequent walking and standing, periods of sitting, occasional lifting of up to 50 pounds, and gowning and wearing PPE for cleanroom entry.
• 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.

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, such as CQA, CQM/OE, or 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 regulatory inspections and client audits, including timely responses to observations and follow-through on commitments.
• Support internal audits and supplier/vendor qualification activities.
• Oversee and continuously improve QMS processes, including deviations, nonconformances, CAPAs, 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 review of records, labeling, chain of custody, and line clearance, and investigation of related deviations.
• Oversee the cleanroom environmental monitoring program, including data review and trending, excursion investigations and CAPAs, 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 quality performance and improvement actions at management review.
• Serve as the primary quality contact for commercial clients and address client concerns and quality events with urgency and transparency.
• 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 roles, responsibilities, and expectations for direct reports; participate in hiring, performance reviews, and development planning.
• Promote accountability, ownership, and quality excellence across the organization.
• Perform other duties as assigned.

What This Job Offers

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