QA Contract Manufacturing Senior Manager
Mission: Ensure 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 :
1. 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.
2. Leadership in managing and improving Almirall's QMS for external operations on commercial pharma and biopharma products, ensuring compliance with regulatory standards.
3. Provide technical expertise to resolve complex quality issues, support manufacturing, QC & QA processes in CMOs, and drive continuous improvement initiatives.
4. Plan and execute GMP audits as Lead Auditor for CMOs, including biologics manufacturing sites and related supplies/services.
5. Manage QA aspects of transfer projects for pharmaceuticals and biologics, ensuring integration into the existing QMS.
6. Support evaluation of Business Development opportunities for commercial pharma products and biologics as a QA expert/SME, aiding decision-making with technical insights.
7. Serve as a training and knowledge resource within the QA CM team on commercial biologics.
Required profile
Education:
* University degree in Life Sciences or related field; biotechnology background or additional training in biotechnology highly valued.
Specific expertise :
* 8-10+ years of experience in external quality management of pharmaceutical/biopharmaceutical products.
* Deep knowledge of manufacturing, QC, QA, and change management of commercial biologics (Drug Substance & Drug Product).
* Proficiency in quality systems with strong knowledge of GXP and international regulatory requirements (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.
Corporate Values
* Care: Listening, empathy, valuing diversity, and supporting each other's success.
* Courage: Challenging the status quo, ownership, and learning from successes and failures.
* Innovation: Centering on patients and customers, creating novel solutions, empowering entrepreneurial mindsets.
* Simplicity: Acting decisively, understanding why before acting, being agile, and keeping things simple.
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