Director, Quality Strategy & Risk Management
Lantheus Holdings, Inc, Bedford, Massachusetts, us, 01730
Overview
Director, Quality Strategy & Risk Management Job Category : Validation/Compliance Requisition Number : DIREC003810 Locations: Bedford, MA 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’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with 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’re 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. 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. Basic Qualifications
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 Qualifications
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. 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 The pay range for this position is between $172,000.00 to $287,000.00 annually. Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until March 5, 2026. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Equal Opportunity Employer. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. 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.
#J-18808-Ljbffr
Director, Quality Strategy & Risk Management Job Category : Validation/Compliance Requisition Number : DIREC003810 Locations: Bedford, MA 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’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with 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’re 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. 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. Basic Qualifications
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 Qualifications
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. 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 The pay range for this position is between $172,000.00 to $287,000.00 annually. Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until March 5, 2026. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Equal Opportunity Employer. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. 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.
#J-18808-Ljbffr