QA Contract Manufacturing Senior Manager

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).

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 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 that the needs of commercial production are met and aligned with regulatory standards.

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 of 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, assisting in decision-making with technical insights.

Serve as a training and knowledge resource within the QA CM Team on commercial biologics.

Required profile

Education :

University degree in a Life Science-related field. 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, and change management of commercial biologics (drug substance & drug product) is essential.

Proficiency in quality systems with strong knowledge of GXP and international regulatory requirements (EU, FDA, ICH).

Excellent oral and written communication skills in English are essential.

Experience in dealing with complex business negotiations in a global environment is required.

Knowledge of biologics devices (e.g., combination products) is 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 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 fostering entrepreneurial mindsets.

Simplicity : We act decisively, avoid over-analysis, understand why before acting, and aim for agility and simplicity.

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