Lead Quality Control

Gland Pharma; France; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Gland Pharma is seeking an experienced Quality Control Lead to manage QC operations across multiple pharmaceutical manufacturing plants in France. You will oversee analytical testing, method validations and transfers, laboratory compliance, and product release while guiding a skilled QC team and ensuring data integrity.

The role requires extensive experience in injectable/sterile QC, strong knowledge of GMP/GxP practices, and proven leadership in a regulated environment.

Qualifications

• 10 to 15 years in Pharmaceutical Quality Control.
• 5+ years mandatory experience in Injectable / Sterile Pharma.
• Expertise in Method Validation, Verification & Transfer.
• Strong knowledge of OOS/OOT, CAPA, Deviations & Change Control.
• Good understanding of GxP, GLP, GDP & Data Integrity.
• Experience in QC team leadership, analytical review & product release.
• Knowledge of Pharmacopoeia, Stability & Regulatory requirements.

Responsabilités

• Lead day-to-day QC operations and laboratory activities.
• Manage analytical method validation, verification and transfers.
• Support ANDA projects, testing, analysis and product release.
• Review analytical reports, COAs, specifications, STPs and GTPs.
• Oversee OOS/OOT, deviations, CAPA, incidents and change controls.
• Ensure GxP, GLP, GDP and data integrity compliance.
• Review calibration, qualification and validation records.
• Oversee stability studies, protocols and regulatory requirements.
• Review raw material, in-process and finished product testing.
• Lead QC team training, analyst qualification and competency.
• Ensure laboratory safety, equipment maintenance and audit readiness.
• Drive continuous improvement and compliance across QC operations.

Connaissances

Quality Control leadership

Laboratory management

GxP compliance

Analytical testing

Problem solving

Description du poste

Quality Control Lead

Job Overview

We are looking for an experienced QC Lead to manage Quality Control operations for multiple pharmaceutical manufacturing plant in France. The role will oversee analytical testing, method validation and transfers, laboratory compliance, product release, investigations, team management, and GxP/data integrity requirements.

Key Responsibilities

• Lead day-to-day QC operations and laboratory activities.
• Manage analytical method validation, verification and transfers.
• Support ANDA projects, testing, analysis and product release.
• Review analytical reports, COAs, specifications, STPs and GTPs.
• Oversee OOS/OOT, deviations, CAPA, incidents and change controls.
• Ensure GxP, GLP, GDP and data integrity compliance.
• Review calibration, qualification and validation records.
• Oversee stability studies, protocols and regulatory requirements.
• Review raw material, in-process and finished product testing.
• Lead QC team training, analyst qualification and competency.
• Ensure laboratory safety, equipment maintenance and audit readiness.
• Drive continuous improvement and compliance across QC operations.

Reporting Structure

Functional Reporting to: Group QC Head

Candidate Requirements

• 10 to 15 years in Pharmaceutical Quality Control.
• 5+ years mandatory experience in Injectable / Sterile Pharma.
• Expertise in Method Validation, Verification & Transfer.
• Strong knowledge of OOS/OOT, CAPA, Deviations & Change Control.
• Good understanding of GxP, GLP, GDP & Data Integrity.
• Experience in QC team leadership, analytical review & product release.
• Knowledge of Pharmacopoeia, Stability & Regulatory requirements.

Location & Visa

• Position is based at our European subsidiary in France.
• Candidate is expected to be based in France for this role.
• France work visa support will be facilitated by the organization for the selected candidate.