Lantheus · 4 days ago
Director, Quality Strategy & Risk Management
Bedford, MA
Full-time
Hybrid
Director/Executive
$172K/yr - $287K/yr
15+ years expLantheus is a leading radiopharmaceutical-focused company dedicated to improving patient outcomes through innovative science. The Director of Quality Strategy & Risk Management will be responsible for quality strategic planning and risk management, implementing programs to enhance the quality management system and leading a team of analysts.
Health DiagnosticsManufacturingMedical
Responsibilities
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 that 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 timeframes
Contributes to budgetary processes, including efficiency opportunities, in collaboration with leadership and ensures expenditure aligns with approved budget
Qualification
Required
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
Preferred
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
Benefits
A comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage
Life and disability benefits
Pre-tax accounts
A 401(k) with company contribution
A variety of other benefits
A generous time off package including paid vacation, holidays, sick days, and paid parental leave
Company
Lantheus
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes across oncology, neurology and cardiology.
501-1000 employees
H1B Sponsorship
Lantheus has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (5)
2022 (5)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
unknown2015-06-25IPO
Leadership Team
Robert Marshall
Chief Financial Officer and Treasurer
Jamie Spaeth
Chief People Officer
Recent News
2026-01-03
2025-12-19
Company data provided by crunchbase