Regional Quality Manager

2 semanas atrás

São Paulo, Brasil Knight Therapeutics Brasil Tempo inteiro

The Regional Quality Performance Manager is responsible for managing the quality activities related to two key areas: the Performance of Knight Quality Management System and local quality operations of Argentina, Chile, and Mexico. Ensure full compliance with all local GMP regulations and corporate policies and act as the main contact person accountable for quality activities in the affiliates.


  • Lead development, maintenance, and continuous improvement of QMS, ensuring compliance, enabling consistency across regions, and leveraging global expertise.
  • Partner with regions to operationalize the global suppliers.
  • Oversees Quality KPI


The ideal candidate is highly organized, details oriented, has good communication capabilities, technical knowledge in quality assurance, quality control, validations, and quality systems; demonstrate good problem-solving skills and can adapt to priorities changes.


PRINCIPAL FUNCTIONS

  • Being responsible for the Quality Performance of Knight Quality Management System in cooperation with international QA Teams, establish and maintain corporate quality objectives, actively promote an effective quality management system (QMS).
  • Lead all the quality team responsible for the Global Quality Systems and local quality operations of the in-license and imported products commercialized in Argentina, Chile, and Mexico.
  • Ensure documented system is in place to support GxP compliance management both internally and externally, with all manufacturers and third parties to whom activities are delegated.
  • Act as a key liaison with Regional Business Partners in International Supply Chain and Commercial and provide strategic direction and alignment with business needs.
  • Act as the Lead of Global Suppliers Qualification planning and executing the Knight annual audits.
  • Implement internal processes for the development of the people of Quality department.
  • Ensure the quality team have all the capabilities required to be compliant to the concepts of Pharmaceutical Quality Systems ICH Q10 and local GMP regulations.
  • Evaluate processes, results, operations, and trends to ensure compliance with local and international standards related to GMP, GLP, GDP. GSP, GPP
  • Manage all QMS activities: document management, training, change control, deviations, CAPAs, supplier qualification, risk management, complaints, batch release, OOS, stability studies, physical chemical and micro tests, qualifications, and validations, APQR, quality agreements, internal audits.
  • Manage quality activities done by local service providers.
  • Maintaining Sites licenses, preparing related amendments and notification to Health Authority.
  • Manage quality activities of on-site audits. Spearheading GMP audits.
  • Conducting inspections of suppliers involved in the manufacturing and/or distribution of products.
  • Manage compliance matters raised internally, by suppliers or corporate partners.
  • Manage any required product recall procedure as per internal SOPs.
  • Lead quality activities to the preparation of CTD modules or responses related to the Chemistry and Manufacturing component of a regulatory dossier for future submission.
  • Create, manage, and review quality KPIs and reports and implement actions to meet the company year objectives.
  • Being responsible for the implementation of the Quality Management System (software QMS) acting as a “go-to” QA Subject Matter Expert.
  • Assure appropriate escalations and notifications to line management.
  • Provide Quality leadership for territory expansion and new product introduction locally.


Required for the Function

  • B.Sc, M.Sc or PhD in Pharmacy
  • Other health sciences graduation can be considered.
  • Language Skills: Spanish fluent, English fluent

Required

  • 10 years within the pharmaceutical industry and acting on Quality activities.
  • Strong knowledge of Microsoft Office Suite
  • Strong Experience in People Management.
  • Ability to influence senior management and other colleagues without direct report lines.
  • Ability to work in a dynamic environment and to constantly redefine priorities according to the company’s business.
  • Strong management and leadership ability.
  • Strong knowledge of the Local regulations and good ability to interpret policies and guidelines.
  • Strong knowledge on aseptic process, clean areas, oral solid and liquid pharmaceutical products manufacturing.
  • Knowledge on analytical method transfer, research.

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