Specialist Pharmaceutical Quality Systems

Specialist Pharmaceutical Quality Systems 

Summary:  

The Pharmaceutical Quality Systems Specialist enables effective adoption, integration, and compliance of digital tools across Quality Control (QC) cell and gene therapy (CGT) laboratory operations. The role spans system onboarding, stakeholder engagement, training, change management, and issue resolution. Primary systems include 1Lab, GQCLIMS, and MODA, and workflow tools such as Businessmap. 

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: 

• Digital Systems Integration: Lead onboarding and configuration of laboratory digital tools across QC processes, ensuring workflows, templates, roles, and access align with operational needs and controlled documentation. 

• Stakeholder Collaboration: Act as liaison among laboratory staff, IT, QA, and project leadership to gather requirements, address concerns, align scope, and communicate status and decisions. 

• Training & Documentation: Develop and deliver user-focused training, SOPs, quick reference guides, and controlled templates; conduct readiness assessments and provide postgolive support. 

• Issue Resolution & Enhancements: Troubleshoot system onboarding and usage challenges; coordinate incident triage and enhancement delivery with technical teams; maintain issue/change logs and user feedback loops. 

• Data Integrity & Compliance: Ensure GxP aligned configuration and use across systems; uphold 21 CFR Part 11/Annex 11 controls, audit trails, role-based access, validated states, and traceability to URS/FRS/test scripts. 

• 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: 

• Associates Degree with 3 years experience OR Bachelor’s in Life Sciences, Chemistry, or related field and one year experience implementing  or administering digital laboratory systems in GMP environments 

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

• Knowledge of 1Lab, GQCLIMS, MODA, and Business map  

• Demonstrated ability to design and deliver training, author SOPs, and lead change management for system rollouts 

• Excellent stakeholder engagement, communication, and issue management; comfort with cross-functional coordination 

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The annual base pay for this position ranges from $82,223 to $123,334. 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.