Job Description: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.
Essential Job Functions- 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.
Skills and 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.
Working Conditions- Position may require periodic evening and weekend work, as necessary to fulfill obligations.
- Must be able to travel occasionally to off-site record retention facilities to conduct inventory-related activities. Activities may include standing for several hours at a time, and lifting, and carrying boxes.
- 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.
The anticipated base salary range for this position is $91,000.00 to $114,000.
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