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

• BS/BA degree with minimum of 8-10 years of experience in a quality discipline, with a minimum of 5 years within Document Control in the pharmaceutical, medical device, or biological industries.
• Experience with electronic Quality Management Systems (eQMS) or document management platforms such as TrackWise Digital, Veeva, MasterControl, or similar systems.
• Experience with global or multi-site document control programs.
• Experience supporting harmonization or transformation of document control processes in a growing or complex organization.
• Demonstrated 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 retention and archival requirements for GxP records.
• Experienced with supporting pharmaceutical and/or medical device GMP compliance regulatory inspections.
• Proficient in technical writing skills.
• Expertise in MS office suite programs.

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.
• Strong attention to detail with the ability to ensure accuracy, completeness, and consistency of controlled documentation.
• 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 $111,000 and $185,000 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 discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until July 30, 2026.