Records & Information Governance Specialist
Listed on 2026-07-13
-
Business
Regulatory Compliance Specialist
Job Title
Records & Information Governance Specialist
Job OverviewThe Records & Information Governance Specialist will support the development, implementation, and maintenance of Xeris’s enterprise‑wide records retention and information governance program. The role supports compliance with SEC requirements and FDA/GxP regulatory frameworks across clinical, pharmacovigilance, manufacturing, and quality records, and contributes to privacy, data governance, and other information compliance initiatives.
Responsibilities- Administer the 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, life‑cycle 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 and disseminate employee communications regarding retention, privacy, and governance.
- Maintain audit‑ready documentation of retention, privacy, and governance activities.
- 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 is preferred.
- Working knowledge of privacy laws (e.g., CCPA/CPRA, GDPR) is 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.
- Periodic evening and weekend work may be required.
- Occasional travel to off‑site record retention facilities to conduct inventory activities.
- Activities may include standing for several hours and lifting and carrying boxes.
- Hybrid position based in Xeris’ Chicago office; minimum of three days per week in the office.
Base salary range: $91,000.00 to $ per year. Additional compensation may include annual bonuses and long‑term incentive awards as applicable.
EEO StatementXeris Pharmaceuticals, Inc. (the “Company”) is an equal‑opportunity employer and does not discriminate based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics, or any other characteristic protected by law. All qualified candidates are given equal opportunity and the Company’s employment selection decisions are based solely on job‑related factors.
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).