(Senior) Manager Sterility Assurance (m/f/d)

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.

Your Responsibilities

• 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.

Your Profile

• 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