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Supplier Quality Assurance Manager

2 months ago

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

Lantheus Medical Imaging Inc., a leader in the medical imaging field, is dedicated to enhancing patient care through innovative diagnostics and therapeutic solutions. With a rich history spanning over six decades, we are committed to fostering a dynamic and inclusive workplace that values diverse perspectives and skill sets.

Role Summary

The Supplier Quality Assurance Manager is responsible for orchestrating quality initiatives to ensure that external partners and suppliers consistently meet or exceed Lantheus' stringent standards for pharmaceutical products and Positron Emission Tomography (PET) drug manufacturing.

Key Responsibilities

  • Collaborate with cross-functional teams, including senior management, to uphold high-quality supplier standards and provide constructive feedback.
  • Design and implement Supplier Quality programs aimed at enhancing supplier performance and process validation.
  • Support the management and resolution of critical issues affecting product release at Contract Manufacturing Organizations (CMOs).
  • Develop, maintain, and review Supplier Quality procedures to ensure compliance with regulatory requirements.
  • Track supplier performance metrics and analyze trends to communicate findings to senior management and suppliers.
  • Lead investigations into supplier-related defects and ensure timely corrective actions are taken.
  • Recommend and implement enhancements to the Supplier Quality Program in response to new regulations and industry standards.
  • Oversee Quality-related activities at supplier facilities, including reviewing supplier deviations and participating in Health Authority inspections.
  • Conduct audits of external suppliers to ensure compliance with quality standards.
  • Contribute to new product introductions and cost reduction initiatives, ensuring adherence to product specifications and regulatory requirements.
  • Provide Quality support for New Product Development and technology transfer activities.
  • Review and execute Quality Agreements as necessary.
  • Analyze customer complaints to support supplier-related investigations and corrective actions.
  • Lead risk management initiatives to identify and mitigate design and process risks associated with supplier activities.
  • Promote safety awareness and adherence to safety practices within the organization.

Qualifications

  • Bachelor's degree in a relevant medical, science, or engineering discipline.
  • A minimum of 7-10 years of experience in quality assurance or supplier quality engineering within the pharmaceutical or life sciences sector.

Additional Requirements

  • In-depth knowledge of US and EU cGMP, ICH guidelines, and ISO standards.
  • Experience in aseptic manufacturing processes and PET drug manufacturing is preferred.
  • Proficient in Microsoft Office applications with strong communication skills.
  • Detail-oriented with a focus on continuous improvement.
  • Certifications such as Black Belt or Green Belt in Six Sigma/LEAN are advantageous.

Core Values

The ideal candidate will exemplify Lantheus' core values:

  • Empower individuals to excel
  • Foster mutual respect and collaboration
  • Embrace learning and adaptability
  • Recognize the importance of health in our hands
  • Take ownership of solutions and drive results

Lantheus is an equal opportunity employer, committed to creating a diverse environment and is proud to be an E-Verify Employer.