ROLE SUMMARY

The Quality Management Specialist will be reporting to the Global Clinical Supply (GCS) Strategic Hubs Team Lead, with a matrix reporting relationship to the Inspection and Risk Management (IRM) Senior Director. The GCS IRM Group instills concepts of Risk Management and Inspection Readiness throughout GCS to ensure that clinical trial project work is conducted to internal and external standards and can withstand Regulatory Inspection.

The Global Clinical Supply Quality Management Specialist role involves interaction with GCS colleagues and contractors to ensure state of program inspection readiness at all times. The role requires understanding of GCP and GMP to support the regulatory requirements and needs of different study types, quality management, inspection readiness, audit/inspection process, and clinical trial processes and systems within GCS. Strong organization and communication skills, both written and oral, are critical.

• Own and update IR trackers.
• Review and trigger prompts for updates to GCS Risk, Decision, Roster tool.
• Support the IRM Inspection Readiness Lead with inspection readiness tools, e.g., GCS Inspection Readiness Storyboard, work with the Clinical Supply Teams.
• Support pre-inspection preparation for global inspections, e.g., Teams channels, documents, presentations.
• Support collection of pre-inspection documentation for inspections conducted in Asia, i.e., Japan, China, Taiwan.
• Ensure information provided during inspections are appropriately archived once inspection is complete.
• Utilize and share learnings, perform lessons learnt from inspections to advance quality culture.

• Update Teams and SharePoint sites accordingly.
• Participate in trend analysis and lessons learned and proactively share and manage components relating to GCS.
• Perform QPI data analysis and trending. Generate presentations and present findings.
• Work in collaboration with GCS/PharmSci Operations Quality (PSOQ) inspection teams and the IRM Inspection Readiness Lead to manage activities and required communications.

• Escalate concerns to Head of GCS Inspection and Risk Management and PharmSci OQ related to timelines, engagement, and quality.
• Work across GCS functional lines and PharmSci OQ to manage and deliver responsibilities.
• Use data applications to surface, highlight, manage and share information to improve quality across GCS in functional line meetings, lesson learned

• Bachelor's Degree
• 3+ years of pharmaceutical experience with solid experience in clinical studies, investigational supplies, supply chain, GMP/GCP Quality
• Demonstrated organizational and project management skills
• Demonstrated strength in analytical skills and attention to detail
• Good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations
• Ability to manage multiple complex projects and has business acumen
• Excellent interpersonal effectiveness and written and verbal communication skills
• Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; tools for analysis and graphing and reporting (Spotfire)

• Ability to progress work activities with oversight
• Regulatory inspection experience
• Knowledge of clinical trial processes and relationships
• Knowledge of GCP requirements and applicable SOPs and regulations
• Project management, administrative, and technical capabilities
• Strong and effective verbal and written communication skills
• Attention to detail
• Quality or compliance experience
• Scientific background in Life Sciences, Regulatory Affairs
• Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines
• Ability to adapt to changing situations and work well under pressure
• Speak/read Japanese and/or Chinese