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 :
* Manage QA partnerships and oversee CMOs manufacturing Pharma and Biopharma products, acting as the key QA contact with CMOs and QA Contract Manufacturing representatives in cross-functional projects.
* Lead the management and continuous improvement of 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 ongoing improvement initiatives.
* Plan and conduct audits as Lead Auditor for GMP audits to CMOs, including biologics manufacturing sites and related supplies/services.
* Manage QA aspects of transfer projects for pharmaceutical and biologics products, ensuring their integration into the existing QMS.
* Support evaluation of Business Development opportunities for commercial pharma products and biologics as a QA expert/SME, aiding decision-making with technical insights.
* Serve as a training resource and knowledge expert within the QA CM Team on commercial biologics.
Required profile
Education;
* University degree in Life Sciences or related field; biotechnology background or additional biotech training is highly valued.
Specific expertise :
* 8-10+ years of experience in external quality management of pharmaceutical and biopharmaceutical products.
* Deep expertise in 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 negotiations in a global environment.
* Knowledge of devices for biologics (e.g., combination products) is advantageous.
Languages :
* Advanced proficiency in written and verbal English and Spanish.
Corporate Values
* Care: we listen, empathize, value diverse perspectives, and support each other's success.
* Courage: we challenge the status quo, take ownership, and learn from successes and failures.
* Innovation: we focus on the patient and customer, creating novel solutions and empowering entrepreneurial mindsets.
* Simplicity: we act decisively, understand the reasons behind actions, and maintain agility by keeping things simple.
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