Quality Assurance Manager

LifeScience Logistics•Lower Macungie Township, PA

16d

About The Position

The Quality Assurance Manager oversees quality and regulatory compliance across 3PL operations, maintaining inspection readiness and leading responses to regulatory inspections and client audits. The role oversees the quality management system, including deviations, CAPAs, change control, document control, training, complaints, returns, recalls, and temperature excursions. It also exercises quality authority over product quarantine, holds, and release, and ensures data integrity in GxP systems. The position provides quality oversight of cleanroom sampling and dispensing, which is conducted day to day under the Sampling and Dispensing Supervisor, and oversees the environmental monitoring program. The manager leads quality improvement and reporting, serves as the primary quality contact for commercial clients, and leads and develops a team of QA professionals. The work is primarily office-based, with regular time in warehouse and cleanroom areas as needed. Travel up to 15% is 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 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 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 perform light to medium work involving frequent walking and standing and periods of sitting; occasional lifting up to 50 lbs; 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 (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, including 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, CAPAs 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 identify root causes and result in effective, sustainable corrective actions.
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, 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.
Ensure client notification requirements are met and support development, maintenance, and compliance with quality agreements.
Lead, coach, and develop QA professionals, including the Sampling and Dispensing Supervisor.
Set clear roles, responsibilities, and expectations for direct reports and participate in hiring, performance reviews, and development planning.
Drive a culture of accountability, ownership, and quality excellence.
Perform other duties as assigned.