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 products manufactured and supplied by external sites.
Responsibilities
* Ensure excellence in QA management of partnerships and CMOs manufacturing pharmaceutical and biopharmaceutical products, acting as the key QA contact for CMOs and as the contract manufacturing QA representative in cross-functional projects.
* Lead the management and improvement of Almirall’s QMS for external operations in commercial pharmaceutical and biopharmaceutical products, ensuring commercial production needs are met and aligned with applicable regulatory standards.
* Provide technical expertise to resolve complex quality issues, support manufacturing, QC, and QA processes at CMOs, and promote continuous improvement initiatives.
* Plan and execute audits, acting as Lead Auditor for GMP audits of CMOs, including biological manufacturing sites and related supply / services.
* Participate in and manage QA aspects of transfer projects for pharmaceutical and biological products, ensuring integration into the existing QMS.
* Support as a QA expert / SME in evaluating business development opportunities for commercial pharmaceutical and biological products, and contribute technical expertise to decision-making processes as requested.
* Act as a training and knowledge reference within the Commercial Biologics QA CM team.
Education
* University degree in a life sciences-related field. Additional training in biotechnology is highly valued.
Experience and Specific Knowledge
* 8–10+ years of relevant experience in external quality management of pharmaceutical / biopharmaceutical products.
* In-depth knowledge and direct experience in manufacturing / QC / QA and change management of commercial biologics (drug substance and drug product) is essential.
* Technical competence in quality systems with strong knowledge of GxP and international regulatory requirements (e.g., EU, FDA, ICH).
* Strong oral and written communication skills in English are essential.
* Knowledge of the global business environment and experience in negotiation in complex business situations are essential.
* Knowledge of devices for biologics (e.g., combination products) will be considered an advantage.
* Advanced written and verbal communication skills in both English and Spanish are essential.
Why work with Almirall?
We are a people-centric company where employees are at their best, patients and customers are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all.
Additionally, for the 17th year in a row, we have been certified as Top Employer Spain, and also Top Employer Germany for the first time. This strengthens our commitment to create a unique work environment that helps our employees to develop their skills to fullest and grow both professionally and as individuals. We are delighted to have a great team that is proactive, innovative, and eager to transform the world of people with skin conditions. We are proud of each one of our employees and their development and growth.
Our 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.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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