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Senior Quality Assurance Manager

Senior Quality Assurance Manager

TFS HealthScienceHamburg, Hamburg, Germany
Vor 30+ Tagen
Stellenbeschreibung

TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes fullservice capabilities resourcing and Functional Service (FSP) solutions.

The Quality Assurance Manager will support quality issue management and corrective and preventive actions (CAPA) management ensuring compliance and driving continuous improvement across processes.

As part of our SRS / FSP team you will be dedicated to a global pharmaceutical / biotech company that is an industry leader in advancing healthcare solutions.

Key Responsibilities

  • Maintain and approve quality issues and CAPAs in the electronic Quality Management System (eQMS).
  • Provide support to internal customers with records in quality issues and root cause / CAPA processes.
  • Contribute to improvements in the eQMS and ensure highquality data metrics and KPIs.
  • Drive quality through proactive support training coaching and consulting adhering to quality by design principles.
  • Advise internal teams on addressing issues while ensuring compliance with global regulations and standard operating procedures.
  • Identify risk areas proactively offering solutions that align with business needs.
  • Participate in health authority inspections.

Qualifications

  • Extensive experience in Quality Assurance within the pharmaceutical / biotech industry or clinical development.
  • Proficient in managing deviations quality issues and CAPA processes.
  • Expertise in continuous improvement methodologies including Lean Six Sigma.
  • Indepth knowledge of GCP regulations ICH guidelines and validation principles (e.g. GAMP5).
  • Basic understanding of other GxP disciplines such as GVP GLP GRP and GMP.
  • Strong understanding of QA principles risk management and regulatory frameworks.
  • Experience with computerized system development.
  • Fluent in English with excellent communication problemsolving and organizational skills.
  • High learning agility selfmotivated and teamoriented with intercultural awareness.

    • What We Offer

    We provide a competitive compensation package comprehensive benefits and opportunities for personal and professional growth in a rewarding environment. Join our team to make a meaningful impact on patients lives working with a supportive and collaborative team.

    A Bit More About Us

    Founded over 27 years ago in Lund Sweden TFS HealthScience is a global Contract Research Organization. With more than 800 professionals across 40 countries we offer flexible solutiondriven clinical research services in key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology. Our core values of Trust Quality Passion Flexibility and Sustainability guide us in creating a unified innovative and collaborative culture driving us towards a healthier future.