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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Head of Quality Compliance Release Management / Qualified Person

Full-Time
No salary listed
Senior
Halle, Germany
In PersonFinancial support is available for a work-related relocation.
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • You have qualification as a Qualified Person under Section 15 of the German Medicines Act or Article 49 of Directive 2001/83/EC.
  • You have several years of leadership experience, ideally at least five years.
  • You have at least five years of professional experience in the pharmaceutical industry.
  • You have professional experience in a quality environment, preferably Quality Control.
  • You have knowledge of sterile or aseptic manufacturing, including sterile solutions, lyophilizates, and powders.
  • You have thorough knowledge of the EU Good Manufacturing Practice guidelines, particularly Annex 1 and Annex 16.
  • You have thorough knowledge of pharmaceutical regulatory requirements, particularly the German Medicines Act.
  • You demonstrate assertiveness and strong communication and organizational skills.
  • You have experience using quality systems and relevant information technology applications, such as Veeva, laboratory information management systems, and enterprise resource planning systems.
  • You have fluent German and English skills, both spoken and written.
Responsibilities
  • You provide professional and disciplinary leadership for a team, including coaching, employee development, and succession planning.
  • You plan resources, prioritize tasks, and ensure efficient achievement of objectives within your area of responsibility.
  • You are responsible for releasing batches of bulk and finished products in accordance with legal requirements.
  • You assess deviations and their impact on product quality.
  • You review and assess batch documentation.
  • You process and assess product complaints in accordance with regulatory requirements.
  • You approve quality agreements in the contract development and manufacturing organization business.
  • You support customer audits and inspections by authorities.
  • You participate in improvement projects in Quality Assurance and pharmaceutical production.
  • You supervise and train pharmacy students in accordance with legal requirements.
Desired Qualifications
  • Professional experience in a quality environment, preferably Quality Control.
  • At least five years of leadership experience is stated as ideal.

About the company

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Simtra BioPharma Solutions

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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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