Document Control, Senior 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 Document Control Senior Specialist who will be responsible for oversight and administration of the corporate document control program within the Quality Systems and Compliance team. This role ensures that corporate quality system documents are established, reviewed, approved, issued, revised, archived, and obsoleted in a controlled and compliant manner in accordance with internal procedures and applicable global regulatory requirements. The position serves as a key business partner to corporate and site functions in maintaining document lifecycle controls within the electronic document management system (eDMS), TrackWise Digital, supporting inspection readiness, driving document management process improvements, and ensuring the integrity, accessibility, and compliance of controlled quality documentation.

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

• Administer and maintain the corporate document control process in alignment with applicable internal procedures and regulatory requirements.
• Responsibility for global governance and oversight of document control lifecycle and process, hierarchy and document templates & formatting.
• Act as the SME to support site Doc Control Admins.
• Serve as a subject matter resource for the eDMS (Trackwise Digital) used to manage controlled documents and associated workflows.
• Provide project and validation support for activities involving modifications, upgrades, and business process changes related to the electronic Document Management System.
• Coordinate the creation, review, approval, issuance, revision, and obsolescence of controlled quality documents.
• Support initiatives such as eForms implementation, document migration, and paper-to-electronic transitions.
• Ensure controlled documents are properly formatted, assigned document numbers, versioned, and routed through the approved workflow process.
• Verify that document changes are reviewed and approved by appropriate functional stakeholders prior to implementation.
• Maintain official document revisions and ensure archived versions are retained in accordance with record retention requirements.
• Support implementation and ongoing administration of document hierarchy structures across corporate and site quality systems, as applicable.
• Ensure document control practices comply with applicable regulatory expectations and company procedures for GxP documentation and record management.
• Provide guidance and training to document authors, reviewers, approvers, and functional stakeholders on document control requirements and processes.
• Support onboarding and refresher training related to document management procedures and eDMS usage.
• Support internal audits, external audits, customer audits, and regulatory inspections by providing requested controlled documents, document history, and evidence of document control compliance.
• Troubleshoot document workflow issues and coordinate with system administrators, IT, or business process owners as needed.
• Provide front / back room support for inspections and audits.
• Assist in the preparation of document control metrics, reports, and summaries for Quality Management Review and other governance forums.
• Identify and escalate documentation compliance risks, overdue periodic reviews, workflow bottlenecks, or procedural nonconformances.
• Support remediation activities related to document control observations, deviations, investigations, CAPAs, or audit commitments.

Basic Qualifications