Quality Assurance Manager (m/f/d)

AiCuris Anti-infective Cures AG

Quality Assurance Manager (m/f/d)

Full time/Reporting to the CEO

AiCuris Anti-infective Cures AG

Wuppertal, Germany

The Powerhouse for Anti-infectives - Committed to making the difference.

AiCuris is a clinical stage biopharmaceutical company developing novel therapeutic candidates for the treatment of serious and potentially life-threatening infectious diseases. Our front-runner drug Prevymis®, a prophylactic treatment for CMV infection in transplant patients, has been outlicensed and is marketed globally since 2017. Prevymis® is followed by an innovative pipeline of antiviral and antibacterial agents including our wholly owned therapeutic candidate Pritelivir, which is currently in phase III clinical development. Passionate about our mission to develop anti-infective medicines for patients in need, a team of internationally recognized experts is driving our research development.

Ready to fight against infectious diseases? Join our team!

At AiCuris, ensuring quality of our products and processes is of the highest importance. Bringing broad knowledge to the quality assurance function, you will work together with our project-teams during drug development up to approval regarding all manufacturing, non-clinical and clinical quality assurance aspects related to our development projects covering small molecules and biologics.

Responsibilities

  • Leads or contributes to the strategic direction for our risk-based quality assurance program;
  • Supports and continuously improves the QM system related to GxP;
  • Manages effective audit programs and performs audits;
  • Performs internal and external system audits;
  • Coordinates with external auditors to prepare, conduct and report outsourced audits;
  • Organizes and attends inspections by authorities or potential partners;
  • Oversees the process on non-compliances, controls corrective and preventive actions (CAPAs) and works together with all in-house functions and departments relating to quality issues;
  • Supports in vendor selection and qualification activities;
  • Provides expertise/consultancies on GxP related items to the development teams;
  • Ensures compliance, maintains and further develops the company´s SOP system under a document management system, including review and approval of SOPs;
  • Plans, organizes and documents SOP and GxP-trainings.

Skills and qualifications

  • Academic degree in natural science, pharmaceutics or medicine;
  • At least 5 years of experience with quality assurance management in the pharmaceutical industry regarding clinical-and non-clinical-related activities (incl. CMC) during development (phase 1- 3) until approval;
  • Very good knowledge of GxP regulations in Germany, Europe and US;
  • Excellent communication, team working and leadership;
  • Good organizational and intercultural skills;
  • Flexible, scientific working style and willingness for continuous education;
  • Fluency in English.

What we can offer

  • A dynamic and family friendly atmosphere with flexible working hours;
  • Working with highly motivated professionals in international and interdisciplinary teams;
  • A culture of independent thinkers embracing debate and initiative;
  • Scientific excellence in research and development aiming to make a difference for patients in need;
  • Flexible combination of on-site and remote work;
  • Regular trainings with opportunities to grow;
  • Attractive remuneration and company pension scheme;
  • A wide range of offers in terms of health care and work-life balance.

How to apply

Interested in joining our team?

Then apply online.

If you have any questions, please do not hesitate to contact us at +49 (0)202 317 63 - 0.

AiCuris Anti-infective Cures AG
Human Resources
Ariane Mlitzko Oliveira
Friedrich-Ebert-Str. 475/Build. 302
42117 Wuppertal, Germany
www.aicuris.com

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Don't forget to mention EuroPharmaJobs when applying.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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