Your responsibilities

• Leadership and development of the QA team, including resource planning, qualification, coaching and targeted staff development.
• Ensuring GMP compliance, data integrity and effectiveness of the quality management system in compliance with regulatory requirements and group-wide quality standards.
• Control and continuous optimization of quality-relevant processes, in particular deviation management, CAPA, change control, complaints, and management of quality risks and escalations.
• Management and support of government inspections, customer and supplier audits as well as self-inspections including follow-up and implementation of agreed measures.
• Responsibility for quality indicators, product quality reviews and management reports, as well as the derivation, implementation and follow-up of sustainable improvement measures.
• Further development and harmonization of quality standards, SOPs and cross-site QM processes in close cooperation with Corporate QA and other relevant stakeholders.
• Central contact person and decision-maker for quality-critical issues as well as professional communication with authorities, customers, suppliers and internal interfaces.
• Promoting a sustainable quality culture and supporting strategic quality and compliance initiatives with a focus on risk management, continuous improvement and operational excellence.

Your profile

Completed studies in natural sciences or comparable training, ideally in pharmacy
Several years of experience in the GMP-regulated environment of the pharmaceutical industry
Regulatory knowledge of GMP and relevant regulations, including corresponding quality assurance requirements.
Solid knowledge of quality management, audits, inspections and documentation
Excellent written and spoken English skills
Good comprehension skills and technical understanding

The Manufacture QA Lead is a key role within the German QA organization to ensure manufacturing, material management and warehousing operations at Wuppertal site (MFG19) are GMP compliant and follow internal procedures and processes

Part III Minimum Requirements for the Position

Educational background and experience

1. At least 8 years of relevant working experience in the pharmaceutical industry, with at least 5 years spent in a Quality role.

2. Working knowledge of Validation principles and knowledge of Computerized System Validation/ Cleaning/ Process Validation is preferred

3. Strong oral and writing English (Chinese and German is a plus)

4. Solid understanding of GMP and European regulations (German drug law is a plus)

5. Results oriented and ability to deliver under pressure in a fast paced environment

6. Think individually with a strong sense of service, decisiveness and responsibility. Good knowledge of Microsoft Office – Powerpoint, Word, Excel

How To Apply:

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Responsibilities