Bachelor's degree in Biology, Chemistry, Engineering, or related field (equivalent experience may be considered).
Minimum of 5 years of quality experience in FDA-regulated industries.
At least 3 years of supervisory experience.
Knowledge of FDA, DEA, PDMA, and DSCSA regulations related to pharmaceuticals and medical devices.
Preferred experience in 3PL, cleanroom operations, and hosting regulatory inspections.
Responsibilities
Ensure compliance with FDA regulations and maintain inspection readiness.
Lead regulatory inspections and client audits, addressing observations promptly.
Oversee and improve core Quality Management System processes.
Ensure thorough investigations and effective corrective actions for quality issues.
Lead initiatives to enhance quality performance and operational efficiency.
Serve as primary quality contact for clients, addressing concerns transparently.
Lead and develop a team of QA professionals, fostering a culture of quality excellence.
Benefits
Opportunity for professional development and training.
Engagement in a collaborative team environment.
Exposure to diverse quality operations in a regulated industry.
Potential for career advancement within the organization.
Full Job Description
Responsibilities
Regulatory Compliance and Inspection Readiness
Ensure compliance with FDA regulations, cGMP, DEA, DSCSA, applicable state licensing requirements, and client-specific quality requirements across all 3PL operations.
Maintain a constant state of inspection readiness for internal, client, and regulatory audits.
Lead and support regulatory inspections and client audits, ensuring timely, complete responses to observations and follow-through on commitments.
Support the internal audit (self-inspection) program and supplier/vendor qualification activities.
Quality Management System
Oversee and continuously improve core QMS processes, including:
Deviations and nonconformances (NCs)
Corrective and Preventive Actions (CAPA), including effectiveness checks
Change control
Document control and record retention
GMP training and qualification of personnel
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 in accordance with approved procedures.
Cleanroom Sampling and Dispensing
Provide quality oversight of cleanroom sampling and dispensing, which is executed day to day under the Sampling and Dispensing Supervisor.
Ensure adherence to SOPs, cGMP, and aseptic practices; timely review of records, labeling, chain of custody, and line clearance; and thorough investigation and resolution of related deviations.
Environmental Monitoring (EM)
Oversee the cleanroom EM program, ensuring data are reviewed and trended, excursions receive timely investigation and CAPA, and cleanroom qualification, cleaning/disinfection, and monitoring requirements are maintained.
Continuous Improvement and Reporting
Lead initiatives that improve quality performance, reduce variation and deviations, and increase Right-First-Time (RFT) execution and operational efficiency.
Analyze quality trends, metrics, and KPIs to identify systemic issues and drive data-based decisions.
Report quality performance and improvement actions at management review.
Client Partnership
Serve as the primary quality contact for commercial clients, ensuring strong communication and partnership.
Address client concerns, deviations, and quality events with urgency and transparency.
Ensure client notification requirements are met in accordance with quality agreements and SOPs.
Support quality agreement development, maintenance, and compliance.
Team Leadership
Lead, coach, and develop a team of QA professionals, including the Sampling and Dispensing Supervisor, to ensure high performance and engagement.
Establish clear roles, responsibilities, and expectations for all direct reports, and participate in hiring, performance reviews, and development planning.
Drive a culture of accountability, ownership, and quality excellence across the organization.
Perform other duties as assigned.
Qualifications and Job Specifications
Bachelor's degree in Biology, Chemistry, Engineering, or a related field (equivalent experience may be considered).
Minimum of 5 years of quality experience in the pharmaceutical, medical device, or other FDA-regulated industry.
Minimum of 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, with the ability to interpret and apply them.
Preferred
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.
Technical Expertise
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; able to prioritize in a fast-paced environment.
Ability to learn and use quality and warehouse management systems: eQMS, LIMS, Tecsys Elite, and WebCTRL (training provided).
Proficiency in Microsoft Outlook, Excel, Word, and PowerPoint.
Additional Employment Requirements
Must successfully pass preliminary employment requirements (e.g., background check and drug screen).
Must be able to travel up to 15%.
Must have a valid driver's license.
Physical/Mental/Visual Demands
Physical: light to medium work with frequent walking and standing, and periods of sitting; occasional lifting of up to 50 lbs; ability to gown and wear PPE for cleanroom entry.
Mental: ability to analyze data, manage multiple priorities, make timely decisions, and communicate effectively under deadlines.
Visual: ability to read documents, screens, and labels, and to visually inspect materials and records.
Working Conditions
Work is performed primarily in an office environment, with regular time in warehouse and cleanroom areas as needed to oversee quality operations.
Warehouse areas may involve temperature variations, noise, and the presence of material-handling equipment.
Equipment Operated
Equipment: laptop computer, cell phone, copier, and desk phone.
Systems: Outlook, Excel, Word, PowerPoint, MQ1 (quality management software), Tecsys Elite, and WebCTRL.
