Quality Assurance Manager

Life Science Logistics•Durham, NC

About The Position

The Quality Assurance Manager oversees quality assurance across 3PL operations, ensuring compliance with applicable FDA, cGMP, DEA, DSCSA, state licensing, and client-specific quality requirements. The role maintains inspection readiness, leads and supports regulatory inspections and client audits, and oversees internal audits and supplier/vendor qualification activities. The manager oversees and improves the Quality Management System, including deviations and nonconformances, CAPA, change and document control, record retention, GMP training, complaints, returns, recalls, and temperature excursions. The role ensures thorough investigations, effective corrective actions, data integrity, and electronic-record compliance. It also exercises quality authority to quarantine, hold, and release products under approved procedures. The position provides quality oversight of cleanroom sampling and dispensing, environmental monitoring, and related qualification, cleaning, disinfection, and monitoring requirements. It leads quality improvement initiatives, reviews trends and KPIs, reports performance and actions at management review, and serves as the primary quality contact for commercial clients. The manager also leads and develops QA professionals, including the Sampling and Dispensing Supervisor, and promotes accountability and quality excellence. Work is primarily in an office, with regular time in warehouse and cleanroom areas as needed. Travel of up to 15% is required. The role involves light to medium physical work, frequent walking and standing, occasional lifting up to 50 pounds, and gowning and PPE use for cleanroom entry. A valid driver’s license and successful completion of preliminary employment requirements, such as a background check and drug screen, are required.

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 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.
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.
Ability to perform light to medium work, including frequent walking and standing, occasional lifting up to 50 pounds, and gowning and wearing PPE for cleanroom entry.

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 or support inspections and audits, respond 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, 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 in accordance with 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 environmental monitoring program, including data review and trending, investigation and CAPA for excursions, and maintenance of 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 primary quality contact for commercial clients; address concerns and quality events, meet client notification requirements, and support quality agreements.
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.