Quality Assurance Manager
1 day ago
We are seeking a highly skilled Quality Assurance Manager to join our team at Lantheus. As a key member of our quality team, you will be responsible for ensuring that our suppliers meet or exceed our requirements for pharmaceutical products and PET drug manufacturing.
Key Responsibilities- Develop and maintain supplier quality programs and processes to improve supplier performance, productivity, and process validation.
- Work closely with cross-functional teams to ensure Lantheus maintains high-quality suppliers and provides appropriate supplier feedback.
- Lead investigations and ensure follow-up and corrective action closure to reduce and eliminate supplier-related defects.
- Recommends and implements improvements to the Supplier Quality Program induced by new regulations, agency guidance documents, industry standards, new technologies, and internal needs.
- Leads and supports quality-related actions and activities at supplier facilities.
- Bachelor's degree in a related medical, science, or engineering discipline.
- Minimum of 7-10 years quality assurance/supplier quality engineering experience in a pharmaceutical/life-science environment.
- Strong knowledge of US and EU cGMP, ICH requirements, ISO 9001, ISO 14385, international, and federal regulatory regulations.
- Experience with aseptic manufacturing, including strong technical understanding of aseptic manufacturing processes, equipment, and facilities requirements.
- Experience with PET drug manufacturing and 21 CFR Part 212 regulations preferred.
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
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