Head of Quality Germany (w/m/d)

at  WuXi Biologics

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.

Please refer the Job description for details