Lead Information Technology Project ManagerOsprey Life Sciences • Waltham, Massachusetts, United States
Lead Information Technology Project Manager
Osprey Life Sciences
- Waltham, Massachusetts, United States
- Waltham, Massachusetts, United States
About
is a leading consulting and services firm specializing in providing comprehensive technology solutions for Life Sciences IT organizations. Our primary focus is on assisting these organizations in effectively and efficiently delivering solutions that support their business objectives and their mission to enhance human health and improve lives. Overview We are seeking a highly experienced Lead Project Manager with strong Computer System Validation (CSV) and GCP compliance expertise to help assess, structure, and drive a complex remediation program across multiple workstreams. This individual will play a critical role in helping the organization establish fit-for-purpose processes, reduce regulatory risk, and improve inspection readiness ahead of anticipated FDA activity in October. Key Responsibilities Program Leadership & Workstream Management Lead and structure a high-priority remediation and inspection readiness program Assess current-state gaps and define remediation workstreams, timelines, dependencies, and resource plans Build and manage integrated project plans between now and October Facilitate prioritization discussions and risk-based decision making across leadership teams Coordinate activities across Quality, IT, Clinical Operations, Regulatory, and external vendors IT Validation & Compliance Oversight Assess and remediate gaps in IT validation processes and system lifecycle management Develop and improve validation governance, SOPs, periodic review processes, and compliance controls Evaluate validation drift, audit trail review processes, access management, and vendor oversight practices Support inspection readiness activities for regulated GxP systems, including Veeva platforms and vendor-managed environments Ensure fit-for-purpose validation and compliance processes are established and operationalized Data Integrity & Inspection Readiness Support triage and remediation planning related to data integrity findings and audit trail concerns Partner with SMEs to assess potential impacts to submission and inspection readiness, and regulatory timelines Assist in developing remediation strategies for inspection findings and compliance risks Help drive overall FDA inspection readiness efforts in advance of anticipated October activity Required Experience & Qualifications 10+ years of experience in Life Sciences consulting, biotechnology, or pharmaceutical environments Strong Project Management experience leading complex, cross-functional remediation or compliance initiatives Deep expertise in Computer System Validation (CSV) / IT Quality within GxP-regulated environments Strong understanding of GCP compliance, inspection readiness, and clinical systems oversight Experience developing or improving: Validation processes SOPs Periodic review programs Vendor oversight frameworks Compliance controls Familiarity with FDA submission timelines and regulatory readiness activities Experience supporting regulated platforms such as Veeva Vault, Veeva RIM, TMF, Quality systems, or related environments Strong ability to manage ambiguity, prioritize risk, and drive execution under compressed timelines Excellent communication and stakeholder management skills Preferred Experience Experience supporting remediation efforts following mock inspections or audit findings Exposure to Clinical Study Data remediation activities Knowledge of Pharmacovigilance (PV) compliance processes Consulting background strongly preferred Experience working within small-to-mid-size biotech organizations We offer an excellent compensation and benefits package with challenge and opportunity to learn, grow and contribute to a stimulating, fast-paced environment. Osprey is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.
Languages
- English
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