Quality Management Specialist

anization 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 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)

PREFERRED QUALIFICATIONS

• 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

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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