5 дней назад
Delivery Lead (Life Sciences Services)
81 980 - 127 152$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Delivery Lead (Life Sciences Services) (CSV/CSA and GAMP 5): Managing strategic IT quality, validation, and compliance engagements for life sciences clients with an accent on pre-sales support, SOW development, regulated systems, and resource planning. Focus on leading validation projects, guiding implementation teams, and solving complex compliance and integration challenges in FDA- and EMA-regulated environments.
Location: Remote within the United States
Base compensation: $81,980.50–$127,152.38–$172,324.25 annually, depending on experience and geographic location.
Company
provides consulting, technology, compliance, and other professional services to public and private-sector clients through specialized industry teams.
What you will do
- Support pre-sales activities by estimating project costs, participating in customer engagements, and authoring and reviewing statements of work.
- Advise life sciences customers on IT quality, validation, compliance, business requirements, best practices, and technology solutions.
- Lead strategic validation projects as a billable Validation Project Manager, with approximately 50–60% billable allocation.
- Coordinate resource allocation, schedules, priorities, and project commitments with practice leads and resource managers.
- Train and guide implementation teams on technical knowledge, customer priorities, and delivery methods.
- Build productive relationships with customers, partners, sales teams, project leads, and key account personnel.
Requirements
- BS/BA degree or 10+ years of relevant experience.
- At least 7 years of experience in CSV/CSA and GAMP 5 risk-based validation in FDA- or EMA-regulated environments.
- Experience with regulated life sciences solutions, including ERP, EQMS, LIMS, systems integrations, and data migration or extraction.
- Experience with testing management tools such as HPAL and JIRA, and digital validation tools such as ValGenesis and Kneat.
- Knowledge of ISO 9001, FDA 21 CFR Part 11, and EU Annex 11 requirements.
- Strong documentation, communication, analytical, problem-solving, ownership, and competing-priority management skills.
Nice to have
- Experience with Sparta Systems products, SAP, NetSuite, Dynamics ERP, or automated testing software.
Culture & Benefits
- Flexible work arrangements and a supportive environment focused on growth, collaboration, and professional development.
- Flexible Time Off available from the first day, plus paid holidays and possible year-end time off.
- Health, dental, vision, life, accident, disability, and wellness benefits, including an HSA employer contribution.
- Paid parental bonding leave and 401(k) contributions.
- Tuition reimbursement, referral bonuses, pet insurance, and paid community volunteering time.
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