Director, Quality Systems

4 weeks ago

North Billerica, United States Lantheus Medical Imaging Inc Full time
Job DescriptionJob Description

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

This role is responsible for leading Lantheus’ Quality Systems & Compliance team. This role will oversee the global compliance function and related processes, providing multi-site oversight of laboratory, manufacturing, and distribution operations. Manages and provides direction to Quality Systems, Compliance and Product Quality Complaints staff, ensuring that processes and activities are performed in compliance with company policies, procedures, standards and applicable local, state, federal, and international regulations governing drug products and medical devices. This role will partner with various internal and external cross-functional teams as well as external regulatory and auditing agencies.

Key Responsibilities/Essential Functions

  • 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. Lead or actively participate in implementation of updates and enhancements to these processes.
  • Provide project and Subject Matter Expert support for all activities involving modifications, upgrades and or business process changes related to Quality Systems tools and applications.
  • Develop and implement ways to improve Quality Systems business processes and strategies, which increase efficiency, improve compliance, and reduce system maintenance requirements.
  • Partner with the IT organization to manage initiatives related to Quality Management Systems.
  • Responsible for inspection readiness and manage 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.
  • Respond 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 processes, activities, and teams, including Field Actions and Recalls. Drives formal submission of FDA Field Alert Reports (FAR) and medical device reporting.
  • Provides quality compliance oversight of Pharmacovigilance (PV) to ensure Adverse Event, complaint management and post market surveillance are executed compliantly and in a timely manner.
  • Manages the creation and maintenance of compliance metrics, development of trend data of audit / inspection observations and communication of results expediently to applicable groups.
  • Identify areas of improvement and participate in process improvement initiatives. Implements quality and process improvements evaluating multiple perspectives. Create new processes aimed at continual improvements, supporting a LEAN company culture. Manage multiple projects, realigning resources, and priorities to meet challenging timeframes.
  • Responsible for driving functional excellence though the tactical execution of improvement activities.
  • Manages the range of performance management processes for direct reports. Contributes to budgetary processes, including efficiency opportunities, in collaboration with leadership.
  • Manage the budgeting process for the Quality Systems & Compliance function, and ensure expenditures align with budget.
  • Other duties as assigned.

Basic Qualifications

  • Bachelor’s degree in a related medical, science or business discipline and minimum 15+ years’ functional experience in Quality, Regulatory or comparable compliance discipline within the pharmaceutical, biopharmaceutical, medical device, or equivalent industries; or equivalent combination of education and experience.
  • Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements.
  • Previous people management and/or team leadership experience required.
  • Demonstrated cross functional leadership skills, with ability to lead and develop teams.

Other Requirements

  • Strong planning and project management skills; demonstrated ability to influence and gain commitment from others.
  • Excellent verbal, written and presentation skills at all levels both internally and externally, including regulatory bodies as well as customers.
  • Ability to communicate effectively at all levels of the organization, as well as teach and present complex and/or new ideas with clarity and simplicity.
  • Must be detail oriented with the ability to multitask and respond to ever changing priorities.
  • Ability to work independently, influence with or without authority, facilitate groups with diverse perspectives and bring teams to consensus/alignment.

Core Values:

The ideal candidate will embody Lantheus core values:

  • Let people be their best
  • Respect one another and act as one
  • Learn, adapt, and win
  • Know someone’s health is in our hands
  • Own the solution and make it happen

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