Quality Management Specialist

1 week ago

Makati City, National Capital Region, Philippines Pfizer Full time

Quality Management Specialist page is loaded

Quality Management Specialist Apply locations Philippines - Makati City time type Full time posted on Posted Yesterday job requisition id

The Quality Management Specialist will be r eporting to the Global Clinical Supply (GCS) Manila Operations 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 GCS Quality Management Specialist role will provide support for inspection readiness and pre-inspection preparations for global inspections. The role involves interaction with GCS colleagues and contractors to ensure state of program inspection readiness at all times .

ROLE RESPONSIBILITIES

Responsibilities include the following:

Inspection Readiness

  • Initiate inspection readiness tools, such as GCS Inspection Readiness Storyboard .
  • W ork with IRM Inspection Readiness Lead and the Clinical Supply Teams to ensure inspection readiness tools are finalized .
  • Manage inspection readiness trackers .
  • Support pre-inspection preparation for global inspections ( e.g., notifications, Teams channels, documents, presentations ) .
  • Support collection of pre-inspection documentation for inspections conducted in Asia ( i.e., Japan, China, Taiwan ) .
  • Review and trigger prompts for updates to GCS Risk, Decision, Roster tool.
  • 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.

Quality Management

  • Update Teams and SharePoint sites accordingly .
  • Participate in trend analysis and lessons learned and proactively share and manage components relating to GCS .
  • Perform data analysis and trending, generate presentations, and present findings ( e.g . , IRM quarterly metrics ) .
  • Escalate concerns to Head of GCS Inspection and Risk Management and PharmSci OQ related to timelines, engagement, and quality.
  • Work in collaboration with 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 complexprojects 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

PHYSICAL/MENTAL REQUIREMENTS

Office work only

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Will periodically require working across US, EU, Asia hours to support regulatory activity and/or engagement with global colleagues.

Hybrid Set Up

#LI-PFE

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 #J-18808-Ljbffr

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