Records & Information Governance Specialist

Xeris Pharmaceuticals•Chicago, IL

3d•Hybrid

About The Position

The Records & Information Governance Specialist will support the development, implementation, and maintenance of Xeris’s enterprise-wide records retention and information governance program. This role supports compliance with SEC requirements and FDA/GxP regulatory frameworks, including clinical, pharmacovigilance, manufacturing, and quality records. The position also contributes to privacy, data governance, and other information compliance initiatives across the Company.

Requirements

Bachelor’s degree required.
5+ years of relevant experience in records management, compliance, privacy, or information governance.
Strong organizational, communication, and analytical skills.
Ability to manage confidential information with discretion.

Nice To Haves

Familiarity with GxP and FDA-regulated recordkeeping requirements in the life sciences industry preferred.
Working knowledge of privacy laws (e.g., CCPA/CPRA, GDPR, etc.) preferred.
Experience with legal holds, eDiscovery, or compliance programs is a plus.

Responsibilities

Administer records retention and information governance program, including policies, procedures, and retention schedules.
Maintain retention schedules aligned with FDA (GxP), SEC, and other regulatory requirements applicable to a public biopharmaceutical company.
Partner with Legal, Quality, Regulatory, IT, and business stakeholders to ensure proper record classification, retention, and disposition.
Support management of GxP records, including clinical trial documentation, manufacturing batch records, pharmacovigilance data, and quality system records.
Monitor compliance and assist with audits, inspections, and internal reviews related to recordkeeping.
Execute defensible records disposition and deletion processes.
Administer legal hold processes including tracking, notices, and coordination with Legal and IT.
Assist with document preservation, collection, and organization for litigation, investigations, and regulatory inquiries.
Support privacy program efforts including data mapping, records inventories, and data subject request responses.
Assist with incident response tracking and documentation for data privacy events.
Support data governance initiatives including classification, lifecycle management, and Redundant, Obsolete, Trivial/Transitory, (ROT) data reduction.
Develop training materials and provide guidance to employees on records retention, privacy, and data governance requirements.
Draft/disseminate employee communications accordingly.
Maintain audit-ready documentation of retention, privacy, and governance activities.