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Quality Assurance Manager

2 months ago

Billerica, Massachusetts, United States Lantheus Medical Imaging Inc Full time
Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team at Lantheus Medical Imaging Inc. As a key member of our quality team, you will be responsible for ensuring that our external partners and suppliers meet or exceed our requirements for pharmaceutical products and positron emission tomography (PET) drug manufacturing.

Key Responsibilities
  • Quality Program Development: Develop and maintain supplier quality programs and processes designed to improve supplier performance, productivity, and process validation.
  • Supplier Management: Work closely with cross-functional teams to ensure Lantheus maintains high-quality suppliers and provides appropriate supplier feedback.
  • Investigation and Resolution: Lead investigations and ensure follow-up and corrective action closure to reduce and eliminate supplier-related defects.
  • Regulatory Compliance: Prepare, maintain, and review supplier quality procedures to ensure compliance with customer and local, state, federal, and international regulations.
  • Performance Metrics: Maintain supplier performance metrics, develop trend data of supplier-related processes, and communicate data to senior Lantheus management and suppliers as appropriate.
Requirements
  • Education: Bachelor's degree in a related medical, science, or engineering discipline.
  • Experience: Minimum of 7-10 years quality assurance/supplier quality engineering experience in a pharmaceutical/life-science environment.
  • Skills: Strong knowledge of US and EU cGMP, ICH requirements, ISO 9001, ISO 13485, international and federal regulatory regulations.
  • Additional Requirements: Experienced in aseptic manufacturing, including strong technical understanding of aseptic manufacturing processes, equipment, and facilities requirements. Proficient with Microsoft Office applications. Excellent oral and written skills. Strong attention to detail. Black Belt or Green Belt Six Sigma/LEAN preferred. CQE or CQA preferred.
Core Values
  • Let People Be Their Best
  • Respect One Another and Act as One
  • Learn, Adapt, and Win
  • Know Someone's Health is in Our Hands
  • Own the Solution and Make It Happen