Quality Assurance Manager

LifeScience Logistics•Durham, NC

16d

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 and leads or supports regulatory inspections, client audits, internal audits, and supplier/vendor qualification. The manager oversees the Quality Management System, including deviations, CAPA, change control, document control, training, complaints, returns, recalls, and temperature excursions, while ensuring investigations identify root causes and produce effective corrective actions. The role also ensures data integrity and electronic-record compliance in GxP systems and exercises quality authority over product quarantine, holds, and release. The position provides quality oversight of cleanroom sampling and dispensing, which is performed day to day under the Sampling and Dispensing Supervisor. It oversees environmental monitoring and cleanroom qualification, cleaning, disinfection, and monitoring requirements. The manager leads quality improvement efforts, analyzes trends and KPIs, reports performance at management review, and serves as the primary quality contact for commercial clients. The position leads and develops QA staff, including the Sampling and Dispensing Supervisor, and supports hiring, performance reviews, and development planning. The role requires a bachelor’s degree in a related field or equivalent experience, at least five years of quality experience in a regulated industry, and at least three years of supervisory experience. It requires knowledge of pharmaceutical and medical-device warehousing and distribution regulations. The position may require travel up to 15%, a valid driver’s license, and successful completion of preliminary employment requirements. Work is primarily office-based, with regular time in warehouse and cleanroom areas.

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 ability to interpret and apply them.
Excellent verbal and written communication and presentation skills.
Strong analytical skills, including investigation, root-cause analysis, and quality-metric trending and presentation.
Sound critical-thinking skills and attention to detail.
Strong organization and time-management skills, with 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 provided.
Proficiency in Microsoft Outlook, Excel, Word, and PowerPoint.
Must successfully pass preliminary employment requirements such as a background check and drug screen.
Must be able to travel up to 15%.
Must have a valid driver’s license.
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 (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 regulatory inspections and client 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, including deviations and nonconformances, CAPA and effectiveness checks, change control, document control and record retention, GMP training and personnel qualification, and product complaints, returns, recalls, and temperature excursions.
Ensure investigations are thorough, root causes are identified, 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, aseptic practices, record review, labeling, chain of custody, line clearance, and deviation resolution.
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, increase Right-First-Time execution, and improve 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, deviations, and quality events with urgency and transparency.
Meet client notification requirements under quality agreements and SOPs; support quality agreement development, maintenance, and compliance.
Lead, coach, and develop QA professionals, including the Sampling and Dispensing Supervisor.
Set clear 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.