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, we offer you the opportunity to work in an innovative environment that motivates you to think critically and provides you with opportunities to develop both your personal and professional skills.
We are looking for individuals who are creative and eager to improve performance and achieve excellence in every aspect of work. We provide you with the training and support you need to grow your skills, along with the chance to work on innovative projects that contribute to collective success. Every individual will be able to reach their full potential while contributing to the success of the team.
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Contractor Quality Lead (9)
About the job
Role Description:
The Global External Quality Operations Mission is to drive a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented.
External Supply Operations Quality (ESOQ) supports Pfizer Global Supply by assuring the quality of products manufactured and packaged by external contractors.
ESOQ manages the Quality & Regulatory oversight of approximately 300 global partners.
Accountabilities
Contributes to ensuring external suppliers deliver high quality products on time and in compliance with regulations.
Responsibilities:
Manage product quality and compliance for external contract manufacturers and suppliers.
Assess supplier quality systems, processes, and product specifications.
Support auditing and regulatory inspection activities.
Ensure compliance with GMP and GDP standards.
Manage risks and implement quality improvement plans.
Support onboarding and offboarding of contractors and products.
Make quality decisions ensuring regulatory compliance.
Lead quality decision-making across teams and stakeholders.
Provide leadership within cross-functional teams.
Develop and manage quality agreements.
Review and approve quality and stability reports.
Perform batch disposition endorsement.
Drive continuous improvement initiatives.
Track and document quality actions.
Lead investigations, complaints, and risk assessments.
Provide performance metrics and reports.
Work independently with senior management and stakeholders.
Build and maintain stakeholder relationships.
Support development of innovative quality systems.
Lead cross-functional projects and initiatives.
Support ESOQ leadership as required.
Qualifications:
Bachelor’s degree in Science, Pharmacy, Engineering, or related field.
10+ years in pharmaceutical or medical device quality roles.
Experience with external suppliers and contractors.
Advanced computer skills (MS Office, SAP, QTS, Vault, Documentum, Minitab).
Strong English communication and technical writing skills.
Strong leadership, organizational, and conflict resolution skills.
Knowledge of global GMP standards and compliance practices.
Ability to lead teams and manage complex projects.
Work Location: Hybrid
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