Quality Compliance Manager

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 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 Benefits 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 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. Equal Employment Opportunity Statement Lantheus is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any characteristic protected under applicable federal, state, or local laws and ordinances. 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 View email address on click.appcast.io. Lantheus is an E‑Verify Employer. #J-18808-Ljbffr