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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Head of Quality Compliance Release Management / Qualified Person

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeHalle, GermanyNo salary listedIn-person

About the Job

Requirements

  • Hold the qualification of Sachkundige Person / Qualified Person under §15 AMG or Article 49 of Directive 2001/83/EC.
  • Have several years of leadership experience, ideally at least five years.
  • Have at least five years of professional experience in the pharmaceutical industry.
  • Have experience in a quality environment, preferably in Quality Control.
  • Have knowledge of sterile or aseptic manufacturing, including sterile solutions, lyophilisates, and powders.
  • Have thorough knowledge of EU GMP guidelines, particularly Annex 1 and Annex 16.
  • Have thorough knowledge of regulatory requirements in the pharmaceutical environment, particularly the German Medicines Act (AMG).
  • Have experience with quality systems and relevant IT applications such as Veeva, LIMS, and ERP systems.
  • Have business-fluent spoken and written German and English.

Responsibilities

  • Provide professional and disciplinary leadership for the Release Management team, including coaching, employee development, and succession planning.
  • Plan resources, prioritize tasks, and ensure efficient achievement of objectives within the area of responsibility.
  • Take responsibility for batch release of bulk and finished products in accordance with legal requirements.
  • Assess deviations and their impact on product quality.
  • Review and assess batch documentation.
  • Process and assess product complaints in accordance with regulatory requirements.
  • Approve quality agreements in the CDMO business.
  • Support customer audits and inspections by authorities.
  • Contribute to improvement projects in Quality Assurance and pharmaceutical production.
  • Supervise and train pharmacy students in accordance with legal requirements.

Desired Qualifications

  • Experience in a quality environment, preferably in Quality Control.
  • Ideally have at least five years of leadership experience.

About the Company

Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Simtra BioPharma Solutions is a contract development and manufacturing organization specializing in sterile injectable medicines. It supports pharmaceutical and biotechnology companies with formulation, process development, clinical and commercial manufacturing, filling, packaging and related technical services. Facilities and teams operate under regulated quality systems suited to complex parenteral products. Simtra is a business-to-business manufacturing partner rather than a consumer drug brand, helping sponsors move therapies from development into reliable supply through dedicated production expertise and capacity.

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