As a (Senior) Manager Sterility Assurance (m/f/d), you will play a key role in ensuring global GMP compliance in the areas of microbiology, sterilization, and aseptic manufacturing. You will develop standards, support sites worldwide, and significantly contribute to the continuous improvement of our quality processes.
Conducting and documenting site and laboratory assessments in microbiology, aseptic techniques, and sterilization processes.
Supporting or conducting internal and external assessments, including audits of suppliers and contract laboratories.
Advising production units, QA, QC, and local site teams on closing GMP gaps and strengthening local expertise.
Leading or supporting global quality improvement projects in close collaboration with various production sites.
Preparing training materials for different target groups on microbiological and aseptic topics.
Developing, reviewing, and further enhancing global SOPs, guidelines, and template documents.
Reviewing site documents related to microbiological and aseptic processes.
Summarizing and analyzing microbiological quality metrics and tracking deviations together with the respective sites.
Advanced degree (MSc or higher) in Biology or a related field
At least 10 years’ experience in pharmaceutical quality assurance or quality control
Extensive knowledge of pharmaceutical quality systems and global regulatory requirements (EU GMP, WHO GMP, CFR, ISO 9001)
Strong understanding of microbiological processes as well as compliance requirements according to EU Annex 11 and CFR Part 11
Proven expertise in conducting inspections, and audits in microbiological laboratories and aseptic manufacturing environments
Experience working internationally and willingness to travel up to 50%
Excellent communication skills and fluency in English
Strong teamwork, leadership, and proactive problem-solving abilities
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.
User information & community guidelines: https://www.fresenius-kabi.com/social-media-terms-conditions
Imprint: www.fresenius-kabi.com/imprint
