Senior Specialist Pharmaceutical Quality Systems

 Senior Specialist Pharmaceutical Quality Systems 

Summary: 

The Pharmaceutical Quality Systems Senior Specialist supports Quality Control (QC) cell and gene therapy (CGT) laboratory operations by ensuring the reliability and readiness of laboratory infrastructure. The role emphasizes equipment lifecycle management, cross-functional coordination, and compliant, efficient operations. 

As part of Laboratory Management and Stability (LMS) team, the role supports shared core responsibilities such as stability program coordination, sample flow oversight, inventory management, and the management of OOT/OOS, deviations, CAPAs, and continuous improvement initiatives. 

Key Responsibilities: 

• Laboratory Infrastructure: Manage laboratory infrastructure, utilities, and maintenance programs to ensure operation efficiency. 

• Equipment & Asset Management: Own preventive maintenance and calibration schedules; manage qualification status (IQ/OQ/PQ), lifecycle tracking, service history, and audit readiness. 

• Cross-Functional Coordination: Interface with Facilities, Validation, and IT to address utilities, environmental monitoring, instrument integration, and computerized system support while maintaining QC ownership of readiness. 

• Vendor Oversight: Schedule, escort, and oversee external service vendors; ensure safety, GMP compliance, and complete service documentation. 

• Digital Systems Administration: Admin/power user for GQCLIMS, 1Lab, Businessmap, and MODA. 

• LMS Core Operations Support: Support sample flow oversight across QC CGT labs; assist with investigations for OOT, OOS, deviations, and CAPAs; contribute to stability program; and maintain inventory management processes including Kanban room controls, min/max levels, and timely replenishment to sustain compliant operation. 

• Audit & Inspection Support: Prepare evidence packages (training records, configuration summaries, validation status, change histories) and participate in internal/external audits and inspections. 

Minimum Qualifications: 

• High School Diploma and 10 years of experience or Associate’s degree and 8 years of experience OR Bachelor’s in Life Sciences, Engineering, or related field and 6 years’ experience in GMP laboratory operations (CGT/biologics preferred); experience with equipment qualification and computerized system compliance 

• Strong knowledge of 1Lab, GQCLIMS, MODA, and Businessmap 

• Strong knowledge of GMP/GxP, 21 CFR Part 11/Annex 11, and ALCOA+ 

• Audit/inspection support experience 

• Demonstrated vendor management and cross-functional coordination 

• Excellent stakeholder engagement, communication, and issue management 

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The annual base pay for this position ranges from $98,725 to $148,088. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individ