Team Lead (m/w/d) QA Computer Systems Validation (CSV)
Simtra BioPharma Solutions · Halle, North Rhine-Westphalia, Germany
Posted 23 days ago
or apply directly on Simtra BioPharma Solutions's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 23 days Simtra BioPharma Solutions's roles stay open a median of 43 days
- Reposted
- No
- Salary listed
- No 3% of Simtra BioPharma Solutions's roles list one
- Ghost-job risk at Simtra BioPharma Solutions
- high 49 stale, 9 reposted of 103 open
- Hiring momentum
- 140 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-09-17
Measured from postings appearing on and disappearing from Simtra BioPharma Solutions's own greenhouse board since 2026-08-03. Full hiring picture for Simtra BioPharma Solutions.
About this role
As a Team Lead in QA Computer Systems Validation (CSV) at Simtra, you will be responsible for planning, executing, and continuously improving the CSV and Computer Software Assurance (CSA) processes in a GMP-regulated environment. Your role includes evaluating IT systems, coordinating CSV activities, conducting investigations related to GMP deviations, and collaborating with various teams to ensure compliance with regulatory guidelines. Additionally, you will present CSV topics during audits and inspections, contributing to the overall effectiveness of the CSV program.
- benefits
- 5/5
- freshness
- 4/5
- career value
- 4/5
- role clarity
- 4/5
- pay transparency
- 0/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Simtra BioPharma Solutions as an employer.
What you need
- Completed degree (Bachelor, Master, Diploma) in a scientific, technical, or IT-related field
- At least 5 years of experience in data management, IT systems, CSV/CSA in a GMP environment
- Strong knowledge of relevant regulatory requirements and guidelines (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 skills, logical thinking, and solution-oriented focus
- Very good German and English language skills, both written and spoken
What you get
- Fair collective wage including social benefits such as a 13th salary, vacation pay, company pension scheme, and additional nursing insurance
- On-site modern cafeteria with attractive subsidies
- 30 days of vacation plus special leave
- Weekly working hours of 37.5 hours
- Job bike leasing
- Corporate benefits: exclusive discounts for employees at numerous well-known brands
Worth weighing
- No salary information provided
- The role involves significant regulatory compliance responsibilities, which may be stressful
- The position requires strong communication skills and collaboration with various teams, which may not suit all candidates
Summarised from Simtra BioPharma Solutions's posting. Read the full original.
Listed by Simtra BioPharma Solutions on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.
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