Document Control, Senior Specialist

Company

Lantheus is a leading radiopharmaceutical company headquartered in Massachusetts.

Document Control Senior Specialist responsible for oversight and administration of the corporate document control program within the Quality Systems and Compliance team.

Ensures 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.

Serves as a key business partner to corporate and site functions in maintaining document lifecycle controls within the electronic document management system (eDMS), Track Wise Digital, supporting inspection readiness, driving process improvements, and ensuring the integrity, accessibility, and compliance of controlled quality documentation.

Based in Bedford, MA; requires on‑site presence three days per week. Open to applicants authorized to work in the United States.

• Administer and maintain the corporate document control process in alignment with internal procedures and regulatory requirements.
• Provide global governance and oversight of document control lifecycle and process, hierarchy, and templates.
• Serve as SME to support site Doc Control Admins.
• Act as resource for the eDMS (Track Wise 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 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, numbered, versioned, and routed through the approved workflow process.
• Verify that document changes are reviewed and approved by appropriate stakeholders prior to implementation.
• Maintain official document revisions and ensure archived versions are retained per record retention requirements.
• Support implementation and ongoing administration of document hierarchy structures across corporate and site quality systems.
• Ensure document control practices comply with 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, external, customer audits and regulatory inspections by providing requested controlled documents, document history, and evidence of 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 preparing document control metrics, reports and summaries for Quality Management Review and other governance forums.
• Identify and raise 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.

• BS/BA degree with 8–10 years of experience in a quality discipline, including at minimum 5 years in Document Control within pharmaceutical, medical device or biological industries.
• Experience with electronic Quality Management Systems such as Track Wise Digital, Veeva, Master Control or similar platforms.
• Experience with global or multi‑site document control programs.
• Experience supporting harmonization or transformation of document control processes in a growing or complex organization.
• Experience administering GxP controlled documentation within an eDMS.
• Strong knowledge of document control principles, quality systems and controlled documentation practices in regulated environments.
• Knowledge of GxP record retention and archival requirements.
• Experience supporting pharmaceutical…