Head of Q&A & Compliance Bioprocess (m/w/d)

☞ Eppendorf Group

見る: 153

更新日: 19-10-2024

場所: Jülich North Rhine-Westphalia

カテゴリー: 法務/契約

業界: Biotechnology Research

レベル: Associate

ジョブタイプ: Full-time

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仕事内容

Your Challenges
  • Manager Responsibility for the Bioprocess Quality Assurance & Compliance team, especially regarding product and process conformity
  • Development and implementation of a regulatory strategy for BP, focusing on the target customer markets (technical and regulatory compliance by target application and target geographies).
  • 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
  • Surveillance and steering of the BP process quality by applying respective KPIs
  • 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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締切: 03-12-2024

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