Director Quality Operations Development Programs & LCM (m/f/d)

Your tasks

• Maintain an up-to-date knowledge of cGxP regulation and applicable standards (especially in the US and EU) and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc)
• Manage a GMP compliant transition of Programs from development to commercial
• Manage GMP compliance during Tech Transfer of manufacturing activities of Drug Substance, Drug Product and/or Combination Product by authoring, reviewing, approving, as applicable, protocols, plans and reports (e.g. Validations) and identify the risks and establish appropriate mitigation plan
• Manage GMP compliance during Analytical Transfer activities
• Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to Drug Substance, Drug Product and Combination Products
• Contribute to QM programs and GMP/GDP/MDR compliance activities as appropriate
• Act on behalf of Senior Director Quality Operations with regards to subjects related to Quality Operations and Quality Life-Cycle Management

Our expectations

• A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field
• Minimum 10 years’ experience in a Quality function with increasing levels of responsibility in the biotech, lifescience or pharmaceutical industry
• Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10), cGMP requirements for Pharmaceuticals and Combination Products, including Biologic Products
• Strong understanding of GMPs and best quality practices with regards to biotech manufacturing processes
• Experience with regulatory agencies such as the FDA, EMA, etc
• Proven success in third-parties’ quality management
• Excellent communication skills in English, both written and oral
• Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm

We offer

• Highly varied range of tasks
• Training opportunities and personal development within the company
• Career opportunities in an international pharmaceutical company
• Attractive, performance-based remuneration (minimum gross annual salary of € 75,000; higher salary depending on qualifications)