Records & Information Governance Specialist

About the role

The Records & Information Governance Specialist supports the development, implementation, and maintenance of Xeris’s enterprise-wide records retention and information governance program. This role ensures compliance with SEC requirements and FDA/GxP regulatory frameworks, including clinical, pharmacovigilance, manufacturing, and quality records.

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.
• Aid in 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.
• Aid in incident response tracking and documentation for data privacy events.
• Support data governance initiatives including classification, lifecycle management, and 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.

Qualifications

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

Skills

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

Benefits

Xeris Pharmaceuticals, Inc. offers a comprehensive benefits package that includes additional elements such as paid time off benefits, various health, vision, and dental insurance options, 401(k) retirement benefits, and more for eligible employees. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Employees are eligible for equity or long-term incentive awards, where applicable. Field Sales role employees are eligible for a quarterly commission structure. Non-Sales role employees are eligible for an annual bonus.

Pay

The anticipated base salary range for this position is $91,000.00 to $114,000.00.

Schedule

This is a hybrid position based in Xeris’ Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management’s discretion.