Compliance Manager

Lantheus Brand • N. Billerica, MA

2d • Onsite

About The Position

Lantheus is seeking a Manager of Compliance to provide Quality Assurance expertise for the QA/QC, production and technical organizations to ensure 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.

Requirements

• 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
• Strong knowledge of regulatory requirements and guidance in CFR, USP, ICH, Aseptic Processing, and Equipment Validation.

Nice To Haves

• Experience using risk management tools to analyze and assess risk.
• Lean Six Sigma/continuous improvement experience.
• Aseptic manufacturing
• Experience operating within a QC operation.

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.
• 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.
• 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.

Benefits

• Comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
• Life and disability benefits
• Pre-tax accounts
• 401(k) with company contribution
• Generous time off package including paid vacation, holidays, sick days, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level