We are looking for a QA Contract Manufacturing Senior Manager for our Commercial & External Sites Quality Assurance area. The position is based in San Andreu de la Barca (Barcelona).MissionEnsure excellence in Quality Assurance (QA) management of Contract Manufacturing Organizations (CMOs) and the associated Quality Management System (QMS) for commercial Pharmaceutical and Biopharmaceutical drug products manufactured and supplied by external sites.Functions and key aspects of the role :
Excellence in QA management of partnerships and CMOs manufacturing Pharma and Biopharma products, acting as the key QA contact with CMOs and QA Contract Manufacturing representatives in cross-functional projects.Leadership in managing and improving Almirall's QMS for external operations on commercial pharma and biopharma products, ensuring compliance with regulatory standards and meeting production needs.Provide technical expertise to resolve complex quality issues, support manufacturing, QC & QA processes in CMOs, and drive continuous improvement initiatives.Plan and execute GMP audits, acting as Lead Auditor for audits to CMOs, including biologics manufacturing sites and related supplies/services.Manage QA aspects of transfer projects for pharmaceutical and biologics products, ensuring integration into the existing QMS.Support evaluation of business development opportunities for commercial pharma products and biologics as a QA expert/SME, assisting in decision-making with technical insights.Serve as a training and knowledge resource within the QA CM team on commercial biologics.Required profileEducation :
University degree in a Life Science-related field. A biotechnology background or additional training in biotechnology is highly valuable.Specific expertise :
8-10+ years of experience in external quality management of pharmaceutical/biopharmaceutical products.Deep knowledge and direct expertise in Manufacturing / QC / QA & Change Management of commercial biologics (Drug Substance & Drug Product).Proficiency in quality systems with strong knowledge of GXP and international regulatory requirements (e.G., EU, FDA, ICH).Excellent oral and written communication skills in English.Experience in dealing with complex business situations in a global environment, including negotiation skills.Knowledge of devices for biologics (e.G., combination products) is an advantage.Languages :
Advanced written and verbal communication skills in English and Spanish are essential.Corporate ValuesCare :
We listen & empathize. We value diverse perspectives & backgrounds and support each other's success.Courage :
We challenge the status quo, take ownership, and learn from successes and failures.Innovation :
We focus on patients and customers, creating novel solutions and fostering entrepreneurial mindsets.Simplicity :
We act decisively, understand the reasons before acting, and strive for agility and simplicity.
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