About this role
About Human Pharmaceutical Business With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Position Summary ： The Quality Assurance Specialist supports the effective operation, maintenance, and continuous improvement of the Quality Management System (QMS). The role performs quality oversight activities, monitors compliance and quality performance, supports laboratory quality processes, and promotes a strong quality culture. The position works closely with laboratory and cross-functional stakeholders to ensure that quality processes are implemented consistently, records are complete and traceable, and improvement actions are followed through to closure.
Key Responsibilities ： Quality Oversight • Monitor quality KPIs, analyze trends, prepare periodic reports, and follow up improvement actions. • Coordinate the lifecycle of controlled documents, including drafting support, review, approval, issuance, periodic review, archival, and retirement. • Participate in routine quality walkthroughs of laboratory and operational areas; document observations and track actions to closure. • Conduct periodic checks and reviews against applicable procedures, quality requirements, and identified risk areas. • Coordinate GMP and quality-related training programs, training assignments, completion monitoring, record maintenance, and effectiveness follow-up. • Serve as Local Management System Owner (LMSO) for discrepancy and CAPA management, data integrity, and supplier management. • Follow up deviations, CAPAs, and other quality records to support timely, complete, and effective investigation, approval, implementation, and closure. • Support supplier quality activities, including documentation review, performance monitoring, issue follow-up, and audit-related coordination. Quality System Maintenance & Improvement • Support daily operation, maintenance, and user coordination for quality systems such as LOS, GoTrack, Veeva, GSPECS Cloud, and other applicable platforms. • Participate in discrepancy investigations, root cause analysis, CAPA definition, effectiveness checks, and investigation quality improvement. • Coordinate internal audit and self-inspection activities, including planning, logistics, documentation, finding follow-up, and closure tracking. • Support external audits and inspections through preparation, document coordination, on-site support, response tracking, and remediation follow-up. • Identify opportunities to simplify, standardize, and improve quality processes while maintaining compliance and effective controls. Quality Culture • Organize and coordinate quality training sessions, workshops, awareness campaigns, and employee engagement activities. • Prepare quality communication and learning materials in alignment with site and global quality initiatives. • Promote quality ownership, speak-up behaviors, cross-functional collaboration, learning from experience, and continuous improvement. • Support quality culture assessments and follow-up activities, where applicable.
Laboratory Quality Assurance Focus • Provide quality oversight for GMP analytical laboratory activities and laboratory quality processes. • Apply data integrity principles to laboratory records, analytical data, computerized systems, audit trails, and data review practices. • Support laboratory discrepancies, deviations, OOS/OOT investigations, CAPA implementation, and effectiveness follow-up. • Support lifecycle oversight of laboratory computerized systems, including chromatography data systems and other digital or paperless laboratory solutions, within the assigned QA scope. • Participate in laboratory walkthroughs and periodic checks covering critical materials, controlled records, equipment and system use, good documentation practices, and data integrity risks. • Support inspection readiness and the continuous improvement of laboratory compliance practices. Requirements: - Bachelor’s degree or above in pharmacy, chemistry, biology, or a related scientific discipline. - Typically 2–5 years of experience in Quality Assurance, Quality Systems, or a GMP-regulated environment. Relevant laboratory QA experience is strongly preferred. - Good understanding of GMP, QMS, document control, training management, discrepancy and CAPA processes, data integrity, quality risk management, audit, and inspection requirements.
Knowing about the establishment of CNAS quality system is a plus. - Experience with electronic quality systems or learning/document management systems is required. Familiarity with Veeva, LOS, GoTrack, GSPECS Cloud, chromatography data systems, or laboratory computerized systems is highly preferred. - Good written and verbal communication skills in Chinese and English.