Head of Manufacturing Quality Assurance > Joboolo FR :
Société : Barrington James Lieu : Paris
Description of Responsibilities:
The Head of ManufacturingQualityAssurance 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 QualityAssurance 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.
