Head of Quality Systems

2 weeks ago

North Billerica, United States Lantheus Medical Imaging Inc Full time
Position Overview

Lantheus Medical Imaging Inc. is a leading organization in the field of medical imaging, dedicated to enhancing patient care through innovative diagnostics and therapeutics. With a rich history spanning over 60 years, we pride ourselves on our entrepreneurial spirit and commitment to excellence.

Role Summary

The individual in this pivotal role will lead the Quality Systems & Compliance team, ensuring adherence to global compliance standards across our laboratory, manufacturing, and distribution operations. This position involves managing a dedicated team focused on maintaining the highest quality standards in accordance with applicable regulations governing pharmaceutical and medical device products.

Key Responsibilities

  • Oversee the Quality Systems & Compliance team, ensuring effective management of product quality complaints, post-market surveillance, and compliance audits.
  • Act as the process owner for Quality Systems Management, including Quality Events, Deviation, Non-Conformance, CAPA, and Change Control.
  • Support the implementation of enhancements to Quality Systems tools and applications, providing subject matter expertise.
  • Drive initiatives to improve business processes, increasing efficiency and compliance while reducing maintenance requirements.
  • Collaborate with IT to manage Quality Management Systems initiatives.
  • Ensure inspection readiness and manage regulatory inspection processes, providing training on best practices.
  • Develop and manage an internal auditing program to maintain compliance with policies and regulatory requirements.
  • Track and analyze compliance issues, ensuring alignment with corporate standards.
  • Respond promptly to compliance concerns and facilitate problem resolution.
  • Oversee drug Product Quality Complaint processes and medical device post-market surveillance activities.
  • Manage compliance metrics and trend data, communicating results to relevant stakeholders.
  • Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency.
  • Oversee performance management processes for direct reports and contribute to budgetary planning.
  • Manage the budget for the Quality Systems & Compliance function, ensuring alignment with financial goals.
  • Perform additional duties as assigned.

Qualifications

  • Bachelor's degree in a relevant field with a minimum of 15 years of experience in Quality, Regulatory, or compliance disciplines within the pharmaceutical or medical device industries.
  • Proven knowledge of cGMP, ICH, and global regulatory requirements.
  • Experience in people management and team leadership.
  • Strong cross-functional leadership capabilities.

Essential Skills

  • Excellent planning and project management skills with the ability to influence and gain commitment.
  • Strong verbal and written communication skills, capable of engaging with diverse audiences.
  • Detail-oriented with the ability to manage multiple priorities effectively.
  • Ability to work independently and facilitate consensus among diverse teams.

Core Values

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

  • Empowering individuals to excel
  • Fostering mutual respect and collaboration
  • Embracing learning and adaptability
  • Prioritizing health and safety
  • Taking ownership and driving solutions

Lantheus is committed to equal employment opportunities and values diversity in the workplace.

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