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.

ROLE RESPONSIBILITIES

Inspection Readiness

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.

Engagement

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.

Quality Management

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

BASIC QUALIFICATIONS

Bachelor's Degree3+ years of pharmaceutical experience with solid experience in clinical studies, investigational supplies, supply chain, GMP/GCP QualityDemonstrated organizational and project management skillsDemonstrated strength in analytical skills and attention to detailGood understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operationsAbility to manage multiple complex projects and has business acumenExcellent interpersonal effectiveness and written and verbal communication skillsTechnical 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)

PREFERRED QUALIFICATIONS

Ability to progress work activities with oversightRegulatory inspection experienceKnowledge of clinical trial processes and relationshipsKnowledge of GCP requirements and applicable SOPs and regulationsProject management, administrative, and technical capabilitiesStrong and effective verbal and written communication skillsAttention to detailQuality or compliance experienceScientific background in Life Sciences, Regulatory AffairsStrong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlinesAbility to adapt to changing situations and work well under pressureSpeak/read Japanese and/or Chinese

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

May include domestic and international travel to GCS sites Will periodically require working across US, EU, Asia hours to support regulatory activity and/or engagement with global colleagues.

  
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Logistics & Supply Chain Mgmt

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