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: 

• 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 individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.