Team Lead (m/w/d) QA Computer Systems Validation (CSV)

Simtra is a first-class contract development and manufacturing company that has been bringing sterile injectable drugs to market for over 65 years in collaboration with more than 60 international clients worldwide. Our core specialization is the production of oncology drugs. With the support of over 2,000 employees at our three sites in Bloomington, Indiana, USA; Parsippany, New Jersey, USA and Halle/Westfalen, Germany, we can offer our clients a broad portfolio of delivery systems, including pre-filled syringes, liquid/lyophilized vials, reconstitution diluents, powder-filled vials, and sterile crystallization. In addition to GMP-compliant manufacturing, we offer other services including formulation development support, lyophilization optimization, global regulatory support, as well as secondary packaging. Simtra is made up of diverse teams in various fields! Become part of the team and help provide patients with life-saving medicines worldwide in the future. At our Halle/Westfalen site, we produce medicines for the therapy of various oncological and other life-threatening diseases. For our team, we are looking for you as a Team Lead (m/f/d) QA CSV (2237).

As Team Lead (m/f/d) CSV in the QA Quality Systems department, you will be responsible for planning, executing, and continuously improving Computer System Validation (CSV) and Computer Software Assurance (CSA) at the site. You will contribute to the reliable and compliant data integrity operation of IT systems, applications, databases, and digital processes in a regulated GMP environment. Your responsibilities include, in particular:

• Responsibility for the CSV area at the Halle site
• Implementation of current CSV/CSA guidelines and regulatory requirements at the site and continuous improvement of the CSV program, including further development and creation of workflows and SOPs
• Evaluation of existing, new, or modified IT systems, applications, databases, and tools regarding their relevance for validation or CSA
• Planning, coordination, and execution of CSV/CSA activities according to internal requirements and regulatory expectations
• Participation in projects concerning CSV requirements, including risk-based assessment, documentation, and tracking
• Conducting CSV-related investigations within GMP deviations, determining appropriate CAPAs, and impact assessment
• Creation and analysis of KPIs, trend analyses, and reports on the performance and reliability of the CSV program
• Presentation of CSV/CSA-related topics in client audits and regulatory inspections, as well as responding to professional inquiries
• Close collaboration with local departments, the IT department, global CSV and IT teams, as well as partner sites

You have:

• A completed university degree (Bachelor's, Master's, Diploma) with a science, technical, or IT-oriented education, e.g., in STEM
• At least 5 years of experience in the field of data governance, IT systems, CSV/CSA in a GMP environment
• A solid understanding of relevant regulatory requirements and guidelines will be an advantage (EU GMP Annex 11, PIC/S PI 041-1, FDA Computer Software Assurance, ICH Q9(R1), ISPE GAMP 5 Second Edition and ISPE Pharma 4.0.)
• Strong communication, logical thinking, and problem-solving orientation
• Very good knowledge of German and English, both spoken and written

We offer:

• A fair collective wage agreement including social benefits such as 13th month's salary, holiday pay, company pension scheme, and supplementary long-term care insurance
• Our own modern canteen with attractive subsidies
• 30 days of vacation plus additional leave
• A 37.5-hour work week
• Bicycle leasing (Job-Rad)
• Corporate benefits: exclusive employee discounts from numerous well-known brands
• Good transport links and free parking for employees
• Relocation due to employment? We provide financial support within our relocation cost compensation
• Free corporate sports, e.g., badminton, soccer, and fitness classes
• For motivated and talented people, we offer exciting opportunities at all stages of their professional lives. Gender, age, skin color, origin, sexual orientation, and disability do not matter – on the contrary: we encourage diversity and believe that diversity enriches us

We look forward to receiving your professional experience documents via our online system. Please note that a resume is mandatory – without it, your application will unfortunately not be considered. For questions, please contact Hartmut Sperber (recruiter contact). To learn more about Simtra's privacy policy, please refer to the Simtra Recruitment Platform Global Privacy Notice: » Recruiting Privacy Notice (DE)