Head of Q&a

Vor 3 Tagen

Duesseldorf, Deutschland Eppendorf Vollzeit

Your Challenges- Manager Responsibility for the Bioprocess Quality Assurance & Compliance team, especially regarding product and process conformity-
- Meeting the needs and expectations of Pharma & Biotech customers working in a regulatory (manufacturing) environment (as characterized by FDA’s cGMP, EMA’s GMP, ICH, PICs etc.) in respect to our product offering (instruments, software and onsumables)- Ensuring overall compliance and continuous improvement of QA processes and systems-
- Ensuring supply chain compliance in qualifying suppliers, defining specifications, gathering necessary certificates and managing change notifications- Ensuring manufacturing is in accordance with required standards and traceability- Ensuring the development of products and services are complaint with customer needs and applicable standards- Managing in-field customer-facing QA specialists and in collaboration with Sales team to address customers and regulators’ questions- Communication, negotiation and clarification with Pharma & Biotech customer regarding their regulatory requirements- Proactive definition and implementation of quality systems with emphasis on prevention, and programs to continuously improve the customer satisfaction- Representation of the department and it’s systems during external inspections and audits by authorities and customers- Development, implementation and maintenance of processes during the entire product life cycle by using quality assurance systems- Supporting the commercial functions within BP to manage customers from the regulated market

Your Expertise- Master's degree or equivalent education in Business Administration, Engineering, Science or related fields-
- Relevant years of profound experience in the Quality Management / Regulatory Affair environment in the Pharma/Biotech industry (cGMP, IGMP, ICH, etc)-
- Experience working with and advising senior management teams, representing analysis and recommendations-
- Outstanding and concise verbal and written communication in English-
- Qualification as auditor-
- Accomplished leader and good business partnering skills-
- Strong interpersonal skills, ability to network effectively and establish good working relationships

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