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Director of Quality Management

1 settimana fa

Milano, Lombardia, Italia Brightstar Care of Ft. MyersNaples A tempo pieno

As a Director of Quality Management, you will be responsible for developing and implementing quality strategies to optimize manufacturing processes and ensuring compliance with GMP and regulatory requirements.

Responsibilities:
  • Quality Strategy Development: Design and implement quality strategies to ensure compliance with regulatory requirements.
  • Regulatory Compliance: Ensure adherence to international regulatory standards, including FDA, EMA, and AIFA regulations.
  • Batch Release and Deviations: Oversee batch release activities, deviations, CAPA, change controls, and risk assessments as the Qualified Person.
  • Team Leadership and Training: Lead and manage a team of quality professionals, providing training and development opportunities to foster a culture of quality and continuous improvement.
  • Audit and Compliance: Oversee internal and external audits, driving audit readiness and ensuring timely resolution of findings.

The ideal candidate will have a Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biology, or a related field and recognized QP eligibility under EU Directive 2001/83/EC.