What are the responsibilities and job description for the Senior Quality Assurance Manager position at Jobleads-US?
Job Overview
We are seeking an experienced Quality Control Leader to join our team at Advanced Accelerator Applications, a Novartis company. As a leading innovator in nuclear medicine, we are committed to delivering the next generation of targeted radioligand therapy to cancer patients.
The successful candidate will lead the Millburn Quality Control organization, overseeing release and in-process testing, environmental monitoring, sterility assurance, stability testing, lab investigations, and analytical science and technology.
Key Responsibilities
- Lead the Millburn Site QC function, managing a team of 40 associates and ensuring resource allocation meets timelines and key milestones.
- Develop and strengthen the Quality Culture within the Quality Control organization.
- Ensure quality systems meet all applicable Health Authority regulations, guidelines, etc.
- Set and manage department objectives and performance.
- Evaluate impact and anticipate implications of emerging regulatory requirements, industry trends, and external regulatory actions.
Requirements
- Bachelor's degree in Chemistry, Biology, Pharmacy, Biotechnology, Biomedical Engineering, or related field.
- 10 years' experience in Quality Control, Quality Assurance, Quality Systems, Quality/Regulatory Compliance, Operational GxP areas, Supplier Quality, and/or Post-Market Quality.
- Prior experience with aseptic manufacturing and developing high-performing teams.
- Familiarity with FDA and ex-USA regulatory requirements, as well as industry quality management tools, standards, and quality systems.
About Us
At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
