Compliance Manager COMPL003861

About Lantheus

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, were 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. Were 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 someones health is in our hands.

Summary of role
Lantheus is seeking a Manager of Compliance to provide Quality Assurance expertise for the QA/QC, production and technical organizations to ensure the following: compliance to all cGMPs in issues that affect marketed products and/or raw materials, APIs, excipients or components. The role provides Quality leadership and support within the organization for key strategic initiatives and directives to improve overall company performance and future growth.

This position is based in Billerica, Massachusetts and is an onsite role, and is open to applicants authorized to work for any employer within the United States.

Responsibilities

Design, develop and implement a successful strategy for Quality Compliance oversight within Technical Operations including internal audits, metrics and document control. Monitor and drive key performance metrics to meet Quality compliance.
Strong knowledge of regulatory requirements and guidance in CFR, USP, ICH, Aseptic Processing, and Equipment Validation.
Providing leadership to the Quality and Technical Operations teams as well as other functional departments by guiding Quality Event management activities such as investigations, CAPA remediation, and change control.
Participating in both internal audits and external inspections from regulatory agencies. The Manager will ensure timely responses to observations, identify root causes, and implement CAPAs to fulfill commitments to regulatory authorities.
Driving continuous improvement initiatives at the site to elevate operational excellence.
Offering mentorship and developing talent within the organization to strengthen our team and foster professional growth.
Basic Qualifications

BS/BA degree in a relevant scientific discipline and a minimum of 8 years of progressive Quality experience in the pharmaceutical industry
Experience in participating in and leading both internal and external audits.
4+ years of people management experience
Preferred Qualifications

Experience using risk management tools to analyze and assess risk.
Lean Six Sigma/continuous improvement experience.
Aseptic manufacturing
Experience operating within a QC operation.
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 someones health is in our hands
Own the solution and make it happen
The pay range for this position is between $111,000 and $185,000 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 cov