Head of Manufacturing Quality Assurance

il y a 3 semaines

Paris, Ile-de-France Barrington James Temps plein

Description of Responsibilities:


The Head of Manufacturing Quality Assurance oversees the GMP Quality team and ensures adherence to quality standards and regulations throughout the manufacturing and clinical supply process.


Responsibilities:


  • leadership, mentoring, training, and support to a team of GMP Quality professionals.
  • with stakeholders to develop or revise manufacturing and clinical supply standards.
  • training and compliance guidance on GMP standards to relevant team members.
  • internal and external audits related to manufacturing and clinical supply activities.
  • investigations and resolution of deviations related to manufacturing and clinical supply activities and vendors.
  • readiness for inspections by facilitating meetings, reviewing documents, and conducting mock inspections.
  • during inspections by managing requests and performing quality control reviews of documents.
  • audit, inspection, deviation, and CAPA activities related to vendors to ensure timely closure and high quality.
  • to Qualified Person certification activities by overseeing manufacturing intermediate batch release review.
  • quality updates, maintain meeting minutes, and ensure completion of action items.
  • and approve quality technical agreements with vendors to reflect necessary oversight throughout product development.
  • and report on quality and compliance trends from audits, deviations, inspections, and CAPAs.
  • critical findings and requests to the appropriate authority.
  • opportunities for continuous improvement throughout the product lifecycle.
  • other compliance activities as needed.


Requirements:


  • Education, Training, and Certifications:
  • or Doctorate degree in Pharmacy, Chemistry, Quality Management, or equivalent.
  • in GMP, quality, and compliance.
  • experience or certification as a GMP auditor and Qualified Person preferred.
  • in English.


Professional Experience Level:


  • 10 years of experience in pharmaceuticals, biotechnology, or related healthcare.
  • 8 years of GMP-related Quality Assurance or relevant clinical trial experience.

Technical Skills:

  • in project management and achieving results.
  • to prioritize and manage multiple projects with demanding timelines.
  • to detail and proficiency in analyzing complex data.
  • in developing presentations and conducting trainings.
  • of ICHQ6, ICHQ9, ICHQ10, and regulatory dossiers such as CTA/CTD.
  • in outsourcing management (GMP-Chapter 7).
  • Skills:
  • experience in leading and managing diverse, inclusive, and equitable teams.
  • team player focused on patient and company success.
  • a continuous improvement mindset and positive attitude.
  • communication skills, both verbal and written, with internal and external stakeholders.

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