Head of Quality Germany

vor 5 Monaten

Wuppertal, Deutschland WuXi Biologics Vollzeit

**Organization Description**:
**WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept to commercial manufacturing.**:
**Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites in China, the United States, Ireland, Germany and Singapore. We currently employ over 10,000 people and provide services to more than 400 customers worldwide, including all the top 20 biopharmaceutical companies.**:
**Key Accountabilities**:

- Leadership of the Quality Assurance (QA) and Quality Control (QC) functions within the German Quality organization for the Leverkusen, Wuppertal Elberfeld, and Wuppertal Aprath sites.
- Holder of the role as Head of Quality Assurance for the production sites for biological finished medicinal products in Leverkusen (DP7) and for biological active pharmaceutical ingredients in Wuppertal-Elberfeld (MFG19).
- Development and implementation of the overall quality strategy for Germany in line with the German strategic business plans, the global production strategy, and the corporate quality strategy.
- Responsible for budget, personnel planning, project work, meeting deadlines, personnel management and development, target agreements and the success of the department.
- Overall responsibility for the quality status of the production sites in Germany towards the WuXi Biologics management in Germany and globally, as well as control authorities worldwide.
- Oversee site quality processes such as manufacturing, product release, process quality, quality control, quality systems, qualification, and validation. Establish and monitor quality metrics.
- Ensure that the sites' quality standards, practices, procedures, and documentation comply with cGMP regulations, pharmacopoeias, global, regional, and site-specific requirements of the company, as well as required industry standards.
- Drive the development, implementation, and improvement of the Pharmaceutical Quality Management System (PMS) for the German manufacturing sites as part of continuous improvement.
- Lead the preparation and execution of regulatory inspections and customer audits. Maintaining the state of inspection readiness.
- Interact with customers during customer visits, meetings, project planning and to resolve quality issues.
- Member of the management team of WuXi Biologics Deutschland GmbH.

**Requirements**:

- At least 15 years relevant work experience in quality including 10 years of managerial experiences and 15 years of experience in pharmaceutical industries. Experience in Biologics is preferable.
- Proven track record of accomplishments in the Quality and GMP area.
- Very good knowledge of EMA & FDA regulations, and ICH & WHO guidelines.

**Skills**:

- Excellent oral & written communication skills (English & German).
- Proactive and extraordinary leadership skills.
- Good interpersonal communication skills.
- Excellent organizational skills.

**Education**:

- Advanced degree (Bachelor, Master or PhD) in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or another related field.

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