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Head of Quality Systems and Compliance
2 months ago
Lantheus Medical Imaging Inc. is a leader in the medical imaging sector, with a rich history of over 60 years in enhancing patient care through innovative diagnostic solutions. Our organization is dynamic and rapidly evolving, dedicated to providing cutting-edge diagnostics, targeted therapies, and AI-driven solutions that empower healthcare professionals in their fight against disease.
Role Summary
The Director of Quality Systems and Compliance will spearhead the Quality Systems & Compliance team, ensuring adherence to global compliance standards across laboratory, manufacturing, and distribution operations. This pivotal role involves managing a dedicated team, ensuring that all processes align with corporate policies, industry standards, and regulatory requirements governing pharmaceutical and medical device products.
Key Responsibilities
- Lead the Quality Systems & Compliance team, overseeing product quality complaints, post-market surveillance, and compliance audits.
- Act as the process owner for Quality Systems Management, including Deviation, Non-Conformance, CAPA, and Change Control.
- Support project initiatives related to Quality Systems tools and applications, ensuring efficient implementation of updates.
- Enhance Quality Systems processes to improve efficiency and compliance while minimizing maintenance requirements.
- Collaborate with IT to manage Quality Management Systems initiatives.
- Ensure inspection readiness and manage regulatory inspections across multiple sites, providing training on best practices.
- Develop and execute an internal auditing program to maintain compliance with GxPs and corporate standards.
- Monitor and analyze compliance issues, driving resolutions to align with evolving regulations.
- Oversee the management of product quality complaints and post-market surveillance processes.
- Generate compliance metrics and trend data, communicating results to relevant stakeholders.
- Identify opportunities for process improvements and implement quality initiatives that support a culture of continuous improvement.
- Manage performance processes for direct reports and contribute to budgetary planning.
- Ensure that the Quality Systems & Compliance budget aligns with organizational goals.
- Perform additional duties as assigned.
Qualifications
- Bachelor's degree in a relevant field and a minimum of 15 years of experience in Quality or Regulatory compliance within the pharmaceutical or medical device industries.
- Proven knowledge of cGMP, ICH, and global regulatory requirements.
- Experience in team leadership and cross-functional collaboration.
Essential Skills
- Strong project management and planning capabilities.
- Excellent communication skills, both verbal and written, with the ability to engage with various stakeholders.
- Detail-oriented with strong multitasking abilities.
- Capacity to work independently and influence cross-functional teams.
- Willingness to work onsite as required.
Core Values
The ideal candidate will embody Lantheus' core values:
- Empower individuals to excel
- Foster mutual respect and collaboration
- Embrace learning and adaptability
- Prioritize patient health and safety
- Take ownership and drive solutions
Lantheus is committed to fostering an inclusive workplace and is an equal opportunity employer.
