RBW Consulting

About the Company

RBW Consulting is a proudly B Corp certified life sciences recruitment & search consultancy with purpose, delivered through what we call Human Intelligence.

We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale.

We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients

We give back by playing an active role in funding initiatives that change lives

We've created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain

Listed Jobs

Company Name

RBW Consulting

Job Title

Quality Assurance Officer (CMC)

Job Description

**Job Title** Quality Assurance Officer (CMC) **Role Summary** Provide end‑to‑end QA oversight for CMC activities in pharmaceutical product development, acting as the QA‑CMC expert within project teams, drafting quality agreements, reviewing product specifications, clinical batch files, and ensuring compliance with GMP and ICH standards. **Expectations** - Deliver independent, rigorous QA support across active ingredient and investigational drug stages. - Maintain high quality standards, proactively identify risks, and drive continuous improvement. - Communicate effectively in English and French with cross‑functional teams and external partners. **Key Responsibilities** - Serve as QA‑CMC on project teams, ensuring quality from active ingredient to investigational drug. - Draft, update, and manage Quality Agreements. - Review Product Specification Files, protocols, stability reports, validation documents, and other supporting documentation. - Conduct clinical batch file reviews for release of active ingredients and investigational injectable drugs. - Evaluate deviations, CAPAs, change controls, anomalies, and out‑of‑specification events. - Lead or contribute to risk analyses supporting CMC strategy. - Participate in due‑diligence activities for sub‑contracted projects. **Required Skills** - Strong knowledge of GMP (Annex 1 & Annex 13) and ICH guidelines. - Analytical, detail‑oriented, organized, and autonomous. - Agile, pragmatic, proactive, and solution‑oriented. - Excellent written and verbal communication in English and French. - Experience in sterile and dry‑form pharmaceutical development. **Required Education & Certifications** - Pharmacist or engineering degree (Pharma, Chemical, or related field). - 3–5 years of quality experience in pharmaceutical development (sterile and dry forms). - Certifications in GMP or related quality disciplines preferred.

Orléans, France

Hybrid

22-10-2025