Director, Quality Systems

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden.  For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. 

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.  At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.  Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands.  We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. 

Summary of Role

The Director, Global Quality Systems, provides strategic leadership and direction in the design, oversight of execution, and effectiveness of the Lantheus Quality Management System (QMS) to ensure compliance with regulatory requirements, industry standards, and company policies. In collaboration with quality and business partners, the position will be responsible for managing an effective QMS that drives operational excellence, risk mitigation, and continuous improvement across the organization. This position within the Quality Organization is vital to the advancement and scaling of the QMS as Lantheus continues to grow and expand. This role requires strong leadership skills, as well as the ability to be independent and autonomous. This role requires expert technical skills and demonstrated experience and capabilities assessing the QMS for effectiveness in execution, collaborating for change management, and championing a culture of quality and continual improvement.

This individual will demonstrate Lantheus core values, as well as model leadership behaviors instilling a culture of quality, engagement, development, and transparency.

Key Responsibilities/Essential Functions

• Provides strategic direction for the development and enhancement of a global quality management system (QMS) to ensure scalability and efficiency to meet emerging and future business needs. Establishes, oversees and maintains the QMS that ensures compliance with regulatory requirements, industry standards, and company policies.
• Oversees the management of the Quality Systems & Compliance team supporting product quality complaints, post market surveillance, Annual Product Quality Reports, field alerts, recalls, internal audit program, inspection readiness and external audits / inspections, Compliance Surveillance, Quality metrics, and Quality Management Review (QMR).
• Process owner for Quality Systems Management processes including Quality Events, Deviation, Non-Conformance, CAPA, Change Control, Complaint Investigations, Document Control, and Training. Drives or actively leads implementation of updates and enhancements to these processes.
• Provides project and Subject Matter Expert support for all activities involving modifications, upgrades and or business process changes related to Quality Systems tools and applications.
• Develops and implements ways to improve Quality Systems business processes and strategies, which increase efficiency, improve compliance, and reduce system maintenance requirements.
• Partners with the IT organization to manage initiatives related to Quality Management Systems.
• Responsible for inspection readiness and managing regulatory inspection processes relating to cGMP including, but not limited to, FDA, MHRA, EMA, Health Canada, and Notified Body, across multiple sites. Provides corporate training on inspection readiness, inspection process and best practices. May act as key liaison for local, state, federal, and global regulatory agency inspections.
• Develops and manages the internal auditing program to ensure a constant state of compliance. Plans and executes compliance audits of internal operations as they relate to GxPs to ensure compliance with policies, procedures, and regulatory requirements; drives timely completion of associated corrective actions. Track and trend multi-site compliance issues to assure alignment with corporate standards.
• Responsible for the Compliance Surveillance program, tracking and trending new and changed regulations, agency guidance documents, industry standards, etc., identifying impact to Lantheus and driving resolution to close gaps.
• Responds in a timely manner to compliance concerns and contribute to problem resolution.
• Responsible for the drug Product Quality Complaint and medical device Post Market Surveillance