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:
* Excellence in QA management of partnerships and CMOs manufacturing Pharma and Biopharma products acting as key QA contact with CMOs and QA Contract Manufacturing representative in cross-functional projects.
* Leadership of the management and improvement of Almirall QMS for external operations on commercial pharma and biopharma products ensuring that needs of commercial production are met and aligns with applicable regulatory standards.
* Provides technical expertise to solve complex quality issues, support manufacturing, QC & QA processes in CMOs and drive continuous improvement initiatives.
* Plan and execute audits acting as Lead Auditor for GMP audits to CMOs, including Biologics manufacturing sites and related supplies/services.
* Is involved and manage QA aspects of transfer projects for Pharmaceutical and Biologics and ensure integration into the existing QMS.
* Support as QA expert/SME role in evaluation of Business Development opportunities for commercial pharma products and biologics and support decision-making processes with technical expertise, as requested.
* Act as a training and knowledge reference within QA CM Team on commercial Biologics.
Required profile
Education:
* University degree in Life Science related field. Biotechnology background or additional training in biotechnology highly valuable.
Specific expertise:
* 8-10+ years related experience in external quality management of pharmaceutical/biopharmaceutical products.
* Deep knowledge and direct expertise on Manufacturing/QC/QA & Change Management of commercial Biologics (Drug Substance & Drug Product) is essential.
* Technical working proficiency in quality systems with strong knowledge of GXP and international Regulatory requirements (e.g. EU, FDA, ICH).
* Oral and written communication skills in English are essential.
* Global business environment knowledge and expertise in dealing and negotiation in complex business situations are essential.
* Knowledge on devices for biologics (e.g., combination product) will be considered an advantage.
Languages:
* Advanced written and verbal communication skills in English and Spanish are essential.
Corporate Values
* Care: we listen & empathize. We value diverse perspectives & backgrounds and we help each other succeed.
* Courage: we challenge the status quo. We take full ownership and we learn from our success & failures.
* Innovation: we put the patient and customer at the center. We create novel solutions and we empower entrepreneurial mindsets.
* Simplicity: we act decisively and avoid over-analysis. We understand why before we act and we are agile & keep things simple.
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