Quality Compliance Specialist

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, 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.

Summary of role – Responsible for coordinating Annual Product Quality Reports (APQR), trending and evaluating Product Quality Complaints, and performing Internal Audits of the quality management system. Other functional responsibilities include authoring and revising Quality System Documentation, and metrics development and reporting.

This position is based in Bedford, MA and requires a presence on-site of three days per week, and open to applicants authorized to work for any employer within the United States.

• Supports writing and submitting Annual Product Quality Reports (APQR) and Post Market Surveillance Reports (PMSR) to senior management for approval.
• Support internal audits and external audits.
• Support the Inspection Readiness program including the training of personnel and conducting walkthroughs to ensure facilities are inspection ready.
• Review documents for compliance with regulatory guidelines and applicable standard operating procedures, authoring document changes as needed.
• Supports the Lantheus  Compliance Surveillance Review program
• Perform trending of Quality Systems and Compliance KPIs for reporting into monthly and quarterly management reviews.
• Maintain control of corporate level GxP documents throughout their lifecycle including creation, review, approval, issuance, revision, archival, and obsolescence.
• Triage and route corporate level document requests across departments.
• Initiates product quality complaints in the Lantheus Quality Management System (QMS)
• Collaborate with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.
• Actively promotes safety and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.
• Actively demonstrates Lantheus values.
• Other duties as assigned.

• Bachelor of Science in a technical discipline or equivalent combination of education and experience.
• Minimum of 5 years of experience in quality systems, quality assurance or other quality discipline in the pharmaceutical, medical device, or biological industries.
• Experienced in generating Annual Product Quality Reviews for commercial pharma products and/or experience with medical device post market surveillance programs.
• Demonstrated proficiency and knowledge of cGMP, ICH, ISO 13485, ISO 14971, and other US and worldwide regulatory requirements.
• Experienced in performing document control activities within an electronic quality management system.
• Previous experience performing quality system audits.
• Experienced in investigating Customer Product Quality Complaints, effectively communicating in written form, and collaborating with various internal and external business partners in problem resolution.
• Organized, detail oriented and self-motivated.
• Experienced with supporting pharmaceutical and/or medical device GMP compliance regulatory inspections.

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