Germany Quality Head

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

The Germany Quality Head will;

1. Lead Quality Assurance and Quality Control department in Germany with full Quality responsibility for the manufacturing site as well as the Quality Control labs associated to the manufacturing site and Wuppertal-Aprath

2. Responsible to ensure cGMP compliance at all operations in Germany

3. Support facilities establishment qualification validation and operation

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

• Provide technical and managerial leadership to German Quality Organization including QA Operations Quality Systems and GMP compliance CQV/CSV QA QA for QC and Warehouse group QPs and QC laboratories.

• Drive Quality System development and improvement for German manufacturing sites.

• Key Member of German Leadership Team for WuXi Biologics GmbH play an integral role in the strategy budget and business planning process ensure cross functional collaborations and leadership execution.

• The role will require extensive liaison with counterparts and business leaders in WuXi Biologics corporate to include the highest level of professional representation of the German sites.

• Develop the overall Quality strategy and targets for Germany aligned with the German strategic business plans global manufacturing strategy and corporate quality strategy.

• Provide Quality oversight of side operations such as manufacturing product release process quality quality control quality systems qualification and validation.

• Ensure that sites Quality standards procedures and documentations are in accordance with cGMP regulations pharmacopoeia and corporate global regional and the sites requirements as well as industry standards and best practices.

• Lead the preparation and execution of regulatory inspections and client audits. Maintain the state of inspection readiness.

• Drive and promote the continuous improvement of Quality processes systems and tools.

• Interact with internal and external customers to resolve quality issues in a timely manner.

• Implement site Quality performance indicators (KPI) in alignment with global WuXiBiologics KPI system and definitions. Measure the quality Team s performance against KPIs.

• Ensure the engagement of team with learning and development initiatives and the performance management system for the site.

• Develop a culture of continuous improvement recognition and constructive feedback in the team. Build and develop a high performing quality organization including attraction development and retention of talents.

• Act as a role model for Quality function and the wider organization in adherence to WuXi corporate core values local site shared commitments and behaviors.

• Establish an overall Quality mindset and an understanding of all site functions about their contribution to quality.

• Prepare and defend Quality budget. Maintain quality operating costs within the approved budget.

• Act as QA site head for MFG19.

• Be flexible to take additional tasks as required by the supervisor.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

• Master or PhD degree in Pharmacy Biology Chemistry or related life science discipline
• At least 15 years of experience in the pharmaceutical industry
• At least 15 years of experience in Quality Assurance or/and Quality Control including team lead

Besondere Kenntnisse / Special Knowledge

• Must be familiar with EMA and FDA regulations
• Excellent oral and writing skills English
• Excellent organizational and management skills
• Proactive and extraordinary leadership skills