GxP Quality Systems Manager

4 days ago


Dublin, Dublin City, Ireland Endo Full time

About Our Company

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Endo is a global healthcare leader dedicated to delivering life-enhancing products through innovation and execution. Our mission is to improve patients' lives by developing and delivering solutions that address unmet medical needs. We foster a workplace where talented individuals can grow and thrive.

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Job Summary

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The Senior Quality Specialist is responsible for leading an individual system and assisting in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities. They provide quality guidance on product transfers and validations and ensure all activities related to manufacturing, packaging testing, release, and distribution of commercial products meet requirements in the U.S. market and other approved markets.

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Key Performance Indicators

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  • Quality Documentation/Reports Review:">
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    • Reviews and prepares controlled documents (e.g., SOPs) required for compliance.">
    • Ensures all activities related to manufacturing, packaging testing, release, and distribution of commercial products meet requirements in the U.S. market and other approved markets.">
    • Develops and implements quality policies and procedures to ensure compliance with applicable laws, regulations, and company quality standards.">
    • Provides quality guidance on product transfers and validations.">
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  • Quality Systems & Investigations:">
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    • Investigates and resolves quality issues with each CMO.">
    • Leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities.">
    • Develops and implements quality systems and procedures to ensure compliance with applicable laws, regulations, and company quality standards.">
    • Collaborates with cross-functional teams to prepare for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities, and special projects.">
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  • Inspection Readiness:">
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    • Participates in cross-functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities, and special projects.">
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Qualifications

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  • Bachelor's degree in a scientific-related field with a minimum of 5-8 years' relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry.">
  • Master's degree in above fields with 3-6 years' relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry OR">
  • Technical and quality background related to the sciences.">
  • Background in sterile manufacturing 1-5 years.">
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Key Competencies

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  • Strong knowledge of all current state, federal, and local US and EU standards and regulations (ICH, EU GMPs, US CFRs, ISO, etc.).">
  • Knowledge of 21-CFR-210, 21-CFR-211, and ICH Guidelines.">
  • Strong knowledge of the principles, concepts, and theories of the compliance/QA discipline.">
  • Strong verbal and communication skills required.">
  • Attention to detail required.">
  • Demonstrated excellent interpersonal skills and flexibility.">
  • Ability to handle multiple priorities in a fast-paced environment.">
  • Good writing skills.">
  • Strong organizational skills.">
  • Ability to build peer relationships.">
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Our Commitment to Diversity, Equity, and Inclusion

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We foster a culture of inclusion that values diversity and promotes equity.

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