Operational Quality Assurance Manager

hace 1 semana


Cuernavaca, Morelos, México Haleon A tiempo completo
Job Summary

We are seeking an experienced Operational Quality Assurance Manager to join our team at Haleon. As an Operational Quality Assurance Manager, you will be responsible for providing effective and efficient support to the Local Operating Country (LOC) Quality Manager to maintain an effective Quality Management System (QMS) and perform LOC Quality Operation activities in compliance with GSK Policies, QMS, and local regulations.

Key Responsibilities
  • Execute and deliver Local Operating Country (LOC) Quality Objectives and LOC Quality Improvement Plan.
  • Perform trending of Quality KPIs to support continuous improvement at the LOC.
  • Maintain a robust, sustainable, and effective QMS (Quality Management System) at the LOC to ensure LOC Quality operations and processes are in full compliance with GSK standards and policies, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and local regulatory requirements.
  • Responsible for quality performance of the assigned 3rd party contractors/service providers/suppliers and ensuring potential quality and compliance issues are identified, communicated, and promptly resolved.
  • Ensure quality systems are in place and in use according to GSK QMS standard.
  • Coordinate LOC Quality Council meetings.
  • Participate in LOC Quality Council(s) in identifying Quality-related issues and continuous improvement opportunities.
  • Perform activities to support risk management process to ensure timely mitigation of quality risks.
  • Perform quality impact assessment to ensure all planned changes at the LOC are appropriately managed.
  • Perform self-inspections at the LOC and 3rd party service providers' operations with potential product quality and regulatory compliance impact.
  • Support investigations and root cause analysis in response to deviations, quality issues, audit findings, and customer complaints.
  • Ensure product supplied to market have the right quality, safety, efficacy, and comply with local regulations.
Requirements
  • Associate degree
  • 5 years of experience in life sciences industry in Quality Assurance role
  • Experience with cGMP (Clinical Good Manufacturing Practices) in pharma testing/secondary repacking
  • Operational experience with Good Documentation Practices (GDP) in warehousing and distribution
Preferred Qualifications
  • Bachelor's degree
  • Ability to engage and work well in cross-functional teams
  • Ability to multi-task and work under pressure
About Haleon

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.



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