Supplier Quality Assurance Manager

2 weeks ago


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

Lantheus Medical Imaging Inc., a leader in the medical imaging sector, is seeking a dedicated professional to oversee supplier quality assurance activities. With a rich history of over 60 years, Lantheus is committed to enhancing patient care through innovative diagnostics and therapeutics.

Role Summary

The successful candidate will be responsible for planning, organizing, and directing quality assurance activities to ensure that external partners and suppliers consistently meet or exceed Lantheus' stringent standards for pharmaceutical products and PET drug manufacturing.

Key Responsibilities

  • Collaborate with cross-functional teams, including senior management, to maintain high-quality supplier relationships and provide constructive feedback.
  • Develop 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).
  • Prepare and review Supplier Quality procedures to ensure compliance with applicable regulations.
  • Maintain and analyze supplier performance metrics, communicating findings to senior management and suppliers as necessary.
  • Lead investigations into supplier-related defects and ensure corrective actions are implemented effectively.
  • Recommend improvements to the Supplier Quality Program based on new regulations and industry standards.
  • Oversee quality-related actions at supplier facilities, including the review of deviations and documentation.
  • Conduct audits of external suppliers to ensure compliance with quality standards.
  • Support new product introductions and improvement projects to meet compliance requirements.
  • Provide guidance for supplier selection and qualification processes.
  • Review customer complaints related to suppliers and support investigations.
  • Lead risk management initiatives to identify and mitigate design and process risks.
  • Promote safety awareness and adherence to safety protocols within the organization.

Qualifications

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

Additional Requirements

  • In-depth knowledge of US and EU cGMP, ICH guidelines, and ISO standards.
  • Experience in aseptic manufacturing processes and PET drug regulations is preferred.
  • Strong proficiency in Microsoft Office applications and excellent communication skills.
  • Attention to detail and a commitment to quality are essential.
  • Certifications such as Black Belt or Green Belt in Six Sigma/LEAN are advantageous.
  • Willingness to travel as needed.

Core Values

The ideal candidate will embody Lantheus' core values, including:

  • Empowering individuals to excel
  • Fostering mutual respect and teamwork
  • Embracing continuous learning and adaptation
  • Recognizing the importance of health in our responsibilities
  • Taking ownership of solutions and driving results

Lantheus is an equal opportunity employer, committed to diversity and inclusion in the workplace.



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