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Quality Assurance Manager

Quality Assurance Manager

SwisslinxVisp, Switzerland
Vor 15 Tagen
Stellenbeschreibung

Job description :

On behalf of our client, a leading global life sciences company, we are seeking an experienced Quality Assurance Manager to oversee compliance and customer quality agreement (QAA) activities for Drug Product Visp . This role requires strong collaboration with cross-functional teams and external stakeholders to ensure regulatory compliance and quality assurance excellence.

Requirements :

Quality Agreements & Compliance :

  • Establish, negotiate, and manage Quality Agreements (QAA) in close collaboration with Drug Product Services (DPS) in Basel / Stein and Drug Substance (DS) sites (e.g., Slough / Visp).
  • Act as the primary QA contact for customers , addressing all quality-related topics, complaints, deviations, changes, and technical inquiries.

Cross-Functional Collaboration & Project Support :

  • Represent Quality Assurance (QA) in cross-functional teams , ensuring seamless collaboration with Manufacturing, QC, Support Functions, Project & Site Engineering for effective Drug Product processes.
  • Act as a QA representative in technical transfer projects and customer meetings , ensuring compliance during new product introductions (NPI) and project execution.
  • Interface with customers regarding deviation reports (DR), change requests (CR) , and other regulatory follow-ups.

    • Risk Management & Documentation Oversight :

  • Support and approve project / product-specific risk assessments and regulatory gap assessments .
  • Review and release critical product documentation, including process descriptions, workflows, manufacturing protocols, transfer documents, test plans, and parameter lists .
  • Assess, review, and approve quality records such as deviations, change controls, CAPAs, investigations, and effectiveness checks in accordance with local GMP guidelines.

    • Continuous Improvement & Quality System Optimization :

  • Support continuous improvement programs to enhance Quality Management Systems (QMS) for Drug Product operations.
  • Author, review, and approve GMP-relevant documents and SOPs , ensuring compliance with industry regulations.

    • Competences : Education :

  • Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biotechnology, or a related field .

    • Experience :

  • 5-10 years of experience in Quality Assurance (QA) within the pharmaceutical or life sciences industry .
  • Strong background in GMP compliance, technical transfers, and risk management .
  • Proven experience in customer-facing QA roles and cross-functional collaboration .

    • Skills :

  • Deep understanding of regulatory requirements, quality risk management, and GMP principles .
  • Strong analytical, problem-solving, and negotiation skills.
  • Ability to manage multiple projects in a fast-paced environment.
  • Fluency in English is mandatory; German is a strong asset .

    • Compensation benefits :

  • The opportunity to drive key quality initiatives within a global pharmaceutical leader.
  • A dynamic and collaborative work environment with significant opportunities for professional growth.
  • Competitive contract conditions with the potential for extension.
    • Jobalert für diese Suche erstellen

    Quality Manager • Visp, Switzerland