Associate Director Quality Compliance / QA Client

Role Summary

Simtra is a premier contract development & manufacturing company that has been bringing sterile injectable medicines to market worldwide for over 65 years in collaboration with more than 60 international customers. Our main focus is on the production of cancer therapeutics. With the support of over 2,000 employees at our three locations in Bloomington, Indiana, USA; Parsippany, New Jersey, USA and Halle/Westphalia, Germany, we can offer our customers a broad portfolio of delivery systems including prefilled syringes, liquid/lyophilized vials, reconstitution diluents, powder filled vials and sterile crystallization. In addition to GMP manufacturing, we also offer other services including formulation and development support, freeze-drying optimization, global regulatory support and secondary packaging.

Simtra is made up of diverse teams in different areas! Become part of the team and support us in providing life-changing medicines to patients worldwide.

At our factory in Halle/Westphalia, we produce medicines for the treatment of various cancer and other life-threatening diseases.

We are looking for you to join our team as Associate Director (m/f/d) Quality Compliance / QA Client (2217).

In this position, you are responsible for the strategic and operational management of the Quality Compliance area including QA Client and ensure continuous compliance with regulatory requirements and the further development of the quality management system. This means in detail:

Technical and disciplinary leadership as well as further development of teams in the areas of Client Communication & Auditing, Data Integrity, Regulatory Intelligence and Release Management

• Ensuring site audit and inspection readiness including planning, organizing and tracking audits, inspections and related CAPAs
• Representing the quality department as the central contact person for authority inspections and customer audits
• Responsible for monitoring data integrity compliance within GMP processes and ensuring appropriate measures are taken to investigate and remediate risks
• Leading internal compliance assessments and self-inspection programs at the site

Establishing and maintaining a global network and promoting collaboration with other locations for the continuous development of an effective quality management system

Promote a sustainable quality and speak-up culture within the organization

Support continuous improvement and operational excellence projects

Requirements

You bring with you

• Successfully completed doctorate or master's degree in pharmacy, biology or a comparable natural science course
• More than 10 years of professional experience in the pharmaceutical GMP environment, ideally in sterile manufacturing or in the CDMO environment
• In-depth experience in quality assurance and extensive knowledge of FDA and EMA requirements
• Several years of leadership experience, preferably at least 5 years leading QA teams
• Experience in setting up and managing inspection readiness programs as well as in leading government inspections
• Strong communication and leadership skills
• Fluent written and spoken German and English skills

Benefits

This is what we offer you

• In-house modern canteen with attractive subsidies
• 30 days vacation plus special vacation
• Job bike leasing
• Corporate Benefits: Exclusive discounts for employees at numerous well-known brands
• Good transport connections and free employee parking spaces
• Job-related move? We provide financial support as part of our moving expenses allowance
• Free company sports such as badminton, football and fitness courses
• We offer interesting opportunities to committed and talented people. Gender, age, skin color, origin, sexual orientation and impairments do not play a role - on the contrary: we promote diversity and believe that diversity is an enrichment.
• We look forward to receiving documents about your previous professional career directly via our online system.
• If you have any questions, please contact Hartmut Sperber -----
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