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Associate Director Quality Compliance / QA Client
Job description
Simtra is a first-class contract development & manufacturing company that has been bringing sterile, injectable drugs to market for over 65 years in collaboration with more than 60 international clients worldwide. Our primary focus is on the manufacturing 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/Westfalen, Germany, we can offer our clients a broad portfolio of administration systems, including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization. In addition to GMP manufacturing, we also offer other services, including formulation and development support, lyophilization optimization, global regulatory support, and secondary packaging.
Simtra is made up of diverse teams in various areas! Become a part of the team and help provide patients worldwide with life-changing medicines in the future.
We manufacture drugs for the therapy of various cancers and other life-threatening diseases at our plant in Halle/Westfalen.
For our team, we are looking for you as an Associate Director (m/f/d) Quality Compliance / QA Client (2217).
In this position, you will be responsible for the strategic and operational management of the Quality Compliance department, including QA Client, and ensure continuous compliance with regulatory requirements and the further development of the Quality Management System. This includes in detail:
- Professional 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 the audit and inspection readiness of the site, including planning, organization, and follow-up of audits, inspections, and associated CAPAs
- Representing the Quality department as the central point of contact for authority inspections and client audits
- Responsibility for monitoring Data Integrity compliance within GMP processes and ensuring appropriate measures for the investigation and remediation of risks
- Leading internal compliance assessments and self-inspection programs at the site
- Building and maintaining a global network and fostering collaboration with other sites for the continuous further development of an effective Quality Management System
- Promoting a sustainable quality and speak-up culture within the organization
- Supporting projects for continuous improvement and operational excellence
What you bring:
- Successfully completed doctorate or master's degree in Pharmacy, Biology, or a comparable natural science degree
- More than 10 years of professional experience in the pharmaceutical GMP environment, ideally in sterile manufacturing or the CDMO environment
- In-depth experience in Quality Assurance and comprehensive knowledge of FDA and EMA requirements
- Several years of leadership experience, preferably at least 5 years in leading QA teams
- Experience in building and managing inspection readiness programs as well as in leading authority inspections
- Strong communication and leadership skills
- Negotiation skills in German and English, both written and spoken
What we offer:
- In-house modern canteen with attractive subsidies
- 30 days of vacation plus special leave
- Job bike leasing
- Corporate Benefits: Exclusive discounts for employees at numerous well-known brands
- Good public transport links and free employee parking spaces
- Relocation due to work? We provide financial support within our relocation cost flat rate
- Free company sports, e.g., badminton, football, and fitness classes
We offer interesting opportunities to dedicated and talented individuals. Gender, age, skin color, origin, sexual orientation, and disabilities play no role – on the contrary: we promote diversity and believe that diversity is an enrichment.
We look forward to receiving your professional background documents directly via our online system.
For any questions, please feel free to contact Hartmut Sperber -----
To learn more about Simtra's data protection policy, please read the global data protection policy of the Simtra Recruitment Platform: » Recruiting Privacy Notice (DE)
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Company information
- Company
- simtrabps
- Location
-
Halle, North Rhine-Westphalia
Germany - Posted
- 1 day ago
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