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

  • Career level: Direct Entry
  • Employment: Fulltime, permanent
  • Start: 01-01-23
  • Location: Jülich / Enfield, CT
  • Job-ID: R5633

Would you like to work for a company who has made it its mission to make a contribution to improving human living conditions? With around 5,000 employees worldwide Eppendorf is a leading Life Sciences company. We develop and distribute devices, consumables and services for use in laboratories worldwide. Our daily work is characterized by our principle: Collaborate on new ideas. You would like to be in an environment in which you can work efficiently? At Eppendorf you will be using your competencies to work on solutions for operational matters in a positive and affirmative working environment. You will be working closely with your team. You are also motivated by responsible tasks? Then apply now!

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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

Please note that we can only consider applications that are submitted online via our application management tool.

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