Fresenius Kabi

Senior Manager Quality Operations (m/f/d)

Fresenius Kabi  •  Federal Republic of Germany (Onsite)  •  3 days ago
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Job Description

As a Senior Manager Quality Operations (m/f/d), you will play a key role in ensuring quality and compliance throughout the lifecycle of innovative biosimilar and combination products.

Working closely with global stakeholders and external partners, you will drive Quality Operations activities, support technology transfers, and help maintain the highest quality standards in a highly regulated environment.

This position can be based in Austria or Germany.

Your responsibilities:

  • Maintain an up-to-date knowledge of cGxP regulation and applicable standards (especially in the US and EU) and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc)
  • Manage a GMP compliant transition of Programs from development to commercial
  • Manage GMP compliance during Tech Transfer of manufacturing activities of Combination Product
  • Manage GMP compliance during Analytical Transfer activities
  • Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to Drug Substance, Drug Product and Combination Products
  • Contribute to QM programs and GMP/GDP/MDR compliance activities as appropriate
  • Manage GMP/GDP/MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers

Your Qualifications:

  • Bachelor's, Master's, or PhD degree in a technical or engineering discipline or related field or equivalent qualification
  • Minimum seven years’ experience in a Quality function with increasing levels of responsibility biotechnology, life sciences, or pharmaceutical industry
  • Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10), cGMP requirements for Pharmaceuticals and Combination Products, including Biologic Products
  • Strong understanding of GMPs and best quality practices with regards to biotech manufacturing processes
  • Experience with regulatory agencies such as the FDA, EMA, etc.
  • Proven success in third-parties’ quality management
  • Professional proficiency in English, both written and spoken; German and/or French are considered an asset
  • Strong communication, leadership, problem-solving, and stakeholder management skills

Drive the future of Biopharma – join #futurefresenius and apply now through our online portal to make an impact!

Fresenius Kabi

About Fresenius Kabi

As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With over 41,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.

Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.

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Imprint: www.fresenius-kabi.com/imprint

Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
Bad Homburg, DE
Year Founded
Unknown
Website
fresenius-kabi.com
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