Production Quality Assurance Manager | Manager (m/w/d) Qualitätssicherung in der Produktion
Simtra Deutschland GmbH
Job Summary
As the Production Quality Assurance Manager, you will lead the QA departments at a pharmaceutical manufacturing site in Halle/Westfalen specializing in life-saving oncology medications. This leadership role involves both disciplinary and technical management of teams responsible for monitoring weighing, formulation, aseptic filling, visual inspection, and packaging processes. You will be instrumental in ensuring GMP compliance, managing environmental monitoring, and overseeing the timely review of batch documentation. Beyond daily operations, you will represent the QA department during international audits and inspections, drive a 'Right-First-Time' quality culture, and manage departmental budgets and resources. This position is ideal for an experienced professional looking to influence operational excellence within a highly regulated FDA/EMA environment. The role offers an attractive compensation package, modern onsite facilities, and a commitment to professional diversity and development.
Required Skills
Education
Completed university degree (Master's or Doctorate/PhD) in a natural sciences field.
Experience
- At least 5 years of professional experience in leading employees within Quality Assurance or Production environments
- Professional experience in aseptic manufacturing within an internationally regulated environment (FDA, MHRA, EMA, etc.) is highly desirable
- Proven experience in handling quality-relevant issues and continuous improvement projects (Right-First-Time performance)
Languages
Additional
- Work location is Halle/Westfalen. Position involves budget responsibility and representation during official inspections. Must have experience with electronic Quality Management Systems (eQMS).
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