Full-Time
Associate Director Quality Compliance / QA Client
Simtra BioPharma Solutions
Sterile injectable drug manufacturing
No salary listed
Halle, Germany
In Person
Financial relocation support is available for job-related moves.
Master's, PhD
 Biology & Biotech (1) |
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- A successfully completed doctorate or master's degree in pharmacy, biology, or a comparable natural-science degree is required.
- More than 10 years of professional experience in a pharmaceutical Good Manufacturing Practice environment is required, ideally in sterile manufacturing or a contract development and manufacturing organization.
- Substantial experience in Quality Assurance and comprehensive knowledge of Food and Drug Administration and European Medicines Agency requirements are required.
- Several years of leadership experience are required, preferably including at least five years leading Quality Assurance teams.
- Experience building and managing inspection-readiness programs and leading regulatory authority inspections is required.
- Fluent German and English skills, both written and spoken, are required.
- Provide strategic and operational leadership for Quality Compliance, including QA Client, and ensure continuous compliance with regulatory requirements and further development of the quality management system.
- Provide professional and disciplinary leadership and development for teams in Client Communication & Auditing, Data Integrity, Regulatory Intelligence, and Release Management.
- Ensure site audit and inspection readiness, including planning, organization, and follow-up of audits, inspections, and associated corrective and preventive actions.
- Represent the Quality function as the central contact person during regulatory authority inspections and customer audits.
- Own oversight of data-integrity compliance within Good Manufacturing Practice processes and ensure appropriate measures to investigate and remediate risks.
- Lead internal compliance assessments and site self-inspection programs.
- Build and maintain a global network and promote collaboration with other sites to continuously develop an effective quality management system.
- Promote a sustainable quality and speak-up culture within the organization.
- Support continuous-improvement and operational-excellence projects.
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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