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 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.
• Identifies areas of quality and process improvement and leads improvement initiatives. Creates new processes aimed at continual improvements, supporting a LEAN company culture. Manages 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.
• Manages the budgeting process for the Quality Systems & Compliance function in collaboration with leadership, and ensures 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.
• Previous oversight of quality systems, compliance, or quality operations areas.
• Broad and deep quality operations experience in Quality Systems and Compliance with leading knowledge of industry trends and best practices for efficiency, compliance and effectiveness.
• Expert proficiency and knowledge of FDA, ICH, ISO and other US and worldwide regulatory requirements.
• Demonstrated experience in the design, management and improvement of electronic global quality management systems (QMS) and governance models across GxP (GLP, GCP, GVP, GMP and GDP).
• Regulatory inspection management experience.
• Proven ability to implement and improve KPIs that are fit-for-purpose enabling effective assessment of the health of quality systems.
• Strong planning and project management skills; demonstrated ability to influence and gain commitment from others.
• Proven leadership capabilities; developing individuals and teams.
• Demonstrated strategic planning and execution skills.
• Strong problem solving and critical thinking skills with ability to make sound decisions.
• Excellent communication and presentation skills with proven track record of building and promoting a culture of Quality and Excellence.
• Detail oriented with the ability to multitask and respond to changing priorities.
• Ability to work independently, influence with or without authority, facilitate groups with diverse perspectives and bring teams to consensus/alignment.

Other Requirements

• This role works five days per week on-site at the Billerica, MA location.

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

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.

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