Quality System Specialist

Job Title: Quality Systems & Data Integrity SME Location: Philadelphia, PA Job Overview We are seeking an experienced Quality Systems & Data Integrity Subject Matter Expert (SME) to support GMP quality and compliance initiatives within a pharmaceutical or biotechnology manufacturing environment. The ideal candidate will possess deep expertise in Data Integrity, Quality Systems, Record Retention, Process Performance, and Product Quality, while driving continuous improvement and ensuring compliance with global regulatory requirements. Key Responsibilities Lead Data Integrity assessments, gap analyses, remediation plans, and compliance initiatives. Ensure adherence to ALCOA+ principles, FDA regulations, EU GMP, ICH guidelines, and 21 CFR Part 11 requirements. Oversee record retention programs and document lifecycle management in accordance with GMP standards. Monitor and analyze process performance metrics to identify trends and implement continuous improvement strategies. Review product quality data, support quality investigations, and drive effective CAPA implementation. Collaborate with Quality Assurance, Manufacturing, Validation, Engineering, and Regulatory Affairs teams to strengthen Quality Systems and GMP compliance. Support internal audits, regulatory inspections, and readiness activities. Provide technical guidance on quality system improvements, data governance, and compliance best practices. Required Qualifications Bachelor's degree in Life Sciences, Engineering, Chemistry, Pharmacy, or a related discipline. 8+ years of Quality Assurance or Quality Systems experience within pharmaceutical, biotechnology, or biologics manufacturing. Strong expertise in Data Integrity, Quality Systems, Record Retention, and GMP documentation practices. Experience performing Data Integrity assessments and implementing remediation strategies. Hands‑on knowledge of Process Performance Monitoring, Product Quality Reviews (PQR/APR), and Quality Metrics. Thorough understanding of FDA, EU GMP, ICH, 21 CFR Part 11, Annex 11, and ALCOA+ principles. Experience supporting investigations, CAPA, change control, deviations, and audit readiness. Excellent analytical, communication, and cross‑functional collaboration skills. #J-18808-Ljbffr United Pharma Technologies Inc