Director, Quality Strategy & Risk Management

About Lantheus

Description

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years.

Today, we are expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world.

At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We are dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress.

Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands.

This role is responsible for quality strategic planning and quality risk management at Lantheus, ensuring growth and competitive advantage. The role will implement a quality risk management program and lead complex strategic initiatives for improving Lantheus' quality management system strategy, utilizing a solid background of quality management principles and tools. This role manages a team of analysts.

This position is based in Bedford, MA and requires a presence on-site of three days per week, and is open to applicants authorized to work for any employer within the United States.

• Leads strategic planning sessions to establish short and long-term quality goals and objectives. Responsible for monitoring the progress of strategic initiatives and reporting results to Quality leadership.
• Develops and implements strategic plans that align with established goals and objectives through analyzing data and trends and identifying opportunities for improvement.
• Identifies and manages risks that could impact the organization's ability to achieve its goals; develops contingency plans to address potential challenges.
• Develops operational and quality objectives (KPIs, metrics, dashboards) that drive improved business outcomes aligned with regulatory requirements and organizational goals. Collects, analyzes, and interprets data to identify trends, support decision-making, and strengthen organizational performance improvement efforts.
• Identifies opportunities for improvement within the Quality Management System and leads complex quality improvement initiatives. Drives Quality Systems modernization, advancing digital transformation, AI-based analytics, and real-time dashboards.
• Leads cross-functional teams to implement strategic initiatives, ensuring projects are completed on time and within budget.
• Responsible for developing and implementing Lantheus' Quality Risk Management program. Design, implement and maintain risk management processes throughout the product lifecycle, ensuring compliance with ICH Q9, by collaborating with cross-functional teams.
• Supports the assessment and planning for Quality on potential strategic business initiatives.
• Manages multiple deliverables and projects, realigning priorities to meet challenging time frames.
• Contributes to budgetary processes, including efficiency opportunities, in collaboration with leadership and ensures expenditure aligns with approved budget.

• Bachelor's degree in a scientific discipline and minimum 15+ years' progressive experience in Quality, Regulatory or comparable compliance discipline in the radiopharmaceutical, pharmaceutical, medical device or related industry, including a minimum of 5 years' management experience and 2+ years' project management experience; or equivalent combination of education and experience.
• Strong knowledge of quality management systems (e.g. 21 CFR Part 820, ICH Q10) and risk management (e.g. ICH Q9, ISO 14971) guidelines, standards, and requirements.
• Demonstrated proficiency with data analytics using application tools (e.g. Excel, Jump, Power BI, etc.) and project management software (e.g. MS Project, Smartsheet, etc.).
• Demonstrated cross functional leadership skills, with ability to lead and develop teams.

• Strong analytical and problem-solving skills.
• Strong planning and project management skills.
• Ability to collaborate across functions with demonstrated ability to influence and gain commitment from others.
• Excellent verbal, written and presentation skills at all levels of the organization.
• Must be detail oriented with the ability to multitask, manage multiple projects, 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.
• PMP certification desired but not required.

The ideal candidate…