Quality Control Deputy Manager
22 hours ago
Saint-Julien-en-Genevois
🔬 We’re Hiring: Quality Control Deputy Manager 📍 Saint-Julien-en-Genevois, France GTP Biologics – Olon France, part of the OLON Group, is a Contract Development and Manufacturing Organization (CDMO) specializing in the development of production processes and the manufacturing of biotherapeutics, including recombinant proteins and antibody-drug conjugates. To support our growth and future challenges, we are looking for a Quality Control Deputy Manager to join our dynamic, human-sized team. 🚀 Key Responsibilities 1. Operational Management & Planning • Develop and manage the annual QC laboratory workload plan (physico-chemical & biological), • Translate strategic plans into weekly operational schedules, • Optimize resource allocation based on project priorities (DS, DP, validation, stability, routine testing), • Monitor performance indicators and report to the QC Manager 1. Quality Support & Document Review • Review and approve QC documentation (analytical reports, validation protocols, SOPs, methods), • Ensure compliance with GMP, data integrity (ALCOA+), and internal standards 1. Deviations & Investigations • Manage QC deviations (OOS, OOT, environmental non-conformities), • Lead root cause investigations (5-Why, Ishikawa), • Define and implement CAPAs and communicate outcomes to stakeholders 1. Training & Competency Development • Oversee QC training and qualification plans, • Support team development through coaching and mentoring, • Ensure continuous competency assessment and certification 1. Method Validation Support • Contribute to validation planning and review protocols/reports, • Ensure availability of equipment, materials, and qualified personnel 1. Compliance & Continuous Improvement • Participate in audits and inspections (internal, client, regulatory), • Drive continuous improvement initiatives (Lean, 5S, digitalization), • Ensure GMP compliance of labs and equipment 🎯 Candidate Profile Education • Master’s degree or Engineering degree in Analytical Chemistry, Biology, Biotechnology, Microbiology, or related field Experience • Minimum 5 years in QC (pharma/biotech), ideally within a CDMO, • Strong GMP knowledge (ICH, Pharmacopoeia, FDA/EMA), • Experience in team coordination or cross-functional leadership Technical Skills • Expertise in analytical techniques (HPLC/UPLC, UV, ELISA, Western Blot), • Knowledge of microbiological testing (bioburden, endotoxins, sterility, EM), • Familiarity with method validation (ICH Q2/Q14) and data integrity Soft Skills • Strong organizational and prioritization skills, • Leadership mindset and team-oriented approach, • Excellent communication and coaching abilities, • Ability to manage multiple complex projects, • Fluent in French and English (written & spoken) 📌 What We Offer • Permanent contract (CDI) – annual package (213 days) + JRTT, • Company health insurance, • 1 day/week remote working, • CET and meal vouchers Olon is committed to providing equal employment opportunities. Our policy ensures that equal employment opportunities are offered without discrimination based on age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, and/or any other legally protected status under applicable local laws.
