Quality Compliance Specialist

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
We are seeking a Quality Compliance Specialist who will be responsible for investigating Customer Quality Complaints, coordinating Annual Product Quality Reports (APQR authoring and revising Quality System Documentation, supporting Document Control activities including overseeing the document life cycle management of corporate policies and procedures within the Lantheus electronic quality management system.

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.

Responsibilities

• Initiates product quality complaints in the Lantheus Quality Management System (QMS)
• Performs routine trending of product complaints and evaluates trends, escalating issues as necessary.
• Collaborate with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.
• 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.
• Review documents for compliance with regulatory guidelines and applicable standard operating procedures, authoring document changes as needed.
• 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.

• Demonstrated proficiency and knowledge of cGMP, ICH, ISO 13485, ISO 14971, and other US and worldwide regulatory requirements.
• Champion quality initiatives to continually support and improve the Quality Management System.
• 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.

Basic Qualifications

• 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 investigating Customer Product Quality Complaints, effectively communicating in written form, and collaborating with various internal and external business partners in problem resolution.
• Experience performing document control activities within an electronic quality management system.
• Organized, detail oriented and self-motivated.
• Exposure to Annual Product Quality Reviews preferred.
• Experience with supporting pharmaceutical and medical device GMP compliance audits is desirable.

Preferred Qualifications

• Good planning and project management skills.
• Good verbal, written and presentation skills at all levels both internally and externally.
• Ability to communicate effectively at a variety of levels of the organization, as well as coach and mentor members of GxP functions on compliance requirements and topics.
• Must be detail oriented with the ability to multitask and respond to ever changing priorities.
• Ability to work independently and drive on time completion of responsibilities and assigned tasks.

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 $89,000-$148,000 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…