Remote Life Sciences Program Manager — GxP & AI-Driven Ops

Localization Academy Inc.; Town of Boston (NY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

LILT is seeking a Life Sciences Program Manager to lead a portfolio of complex accounts, ensuring successful service delivery strategies align with SLAs and business outcomes. You will drive cross-functional initiatives, collaborate with clinical, regulatory, and operations teams, and maintain audit-ready documentation.

The role emphasizes regulatory alignment, quality standards, and proactive stakeholder communication in a remote/hybrid US-based setup.

Qualifications

• 5+ years of experience managing Life Sciences localization programs for pharmaceutical, biotech, CRO or medical device clients.
• Experience in Risk Management, RCA and CAPA procedures as they apply to regulated Life Sciences programs (GxP environments).
• Working knowledge of Life Sciences translation workflows, including linguistic validation and regulated content.
• Familiarity with quality standards and regulations relevant to Life Sciences translation (e.g., ISO 17100, ISO 13485, ICH GCP, EU MDR/IVDR, 21 CFR Part 11).
• Experience supporting client and regulatory audits and maintaining audit-ready documentation.
• Excellent client-facing and internal communication skills.
• Solid organizational skills including meticulous attention to detail and multitasking.
• Analytical and organized problem solving abilities.
• Able to meet deadlines and work under pressure.

Responsibilities

• Produces competitive and well reasoned quotations for Life Sciences services.
• Drive implementation and testing of complex production workflows for efficiency and compliance.
• Monitor production KPIs and report performance against objectives.
• Direct tasks for production resources to meet KPIs and SLAs.
• Maintain audit-ready documentation and support client/regulatory audits.
• Collaborate with stakeholders to ensure quality and regulatory alignment.

Skills

Life Sciences program management

Risk management (RCA/CAPA)

Life Sciences workflows (linguistic, G

Job description

LILT is seeking a Life Sciences Program Manager to lead a portfolio of complex accounts, ensuring successful service delivery strategies align with SLAs and business outcomes. You will drive cross-functional initiatives, collaborate with clinical, regulatory, and operations teams, and maintain audit-ready documentation.

The role emphasizes regulatory alignment, quality standards, and proactive stakeholder communication in a remote/hybrid US-based setup.