Katalyst CRO ยท 2 months ago
IT CSV & CQV Validation Lead
Boston, MA
Contract
Onsite
Senior LevelKatalyst CRO is seeking an IT CSV & CQV Validation Lead to manage validation and quality documentation processes. The role involves leading multiple projects, ensuring compliance with regulatory standards, and serving as a subject matter expert in quality assurance.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop and author comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and other project-related materials
Ensure all documentation complies with applicable regulatory standards such as FDA, EMA, GxP, and other relevant guidelines
Review and approve validation documents to confirm alignment with both project objectives and regulatory requirements
Lead and oversee multiple quality and validation projects, ensuring clear communication of goals, timelines, and key milestones
Proactively identify potential risks and implement mitigation strategies to ensure timely and successful project delivery
Collaborate with internal teams and external stakeholders to ensure alignment on deliverables and expectations
Conduct regular project status meetings and prepare progress reports for stakeholders
Ensure all validation activities and documentation adhere to industry best practices and regulatory requirements
Provide support during internal and external audits by offering expertise in validation and quality assurance
Serve as a subject matter expert in quality systems, validation methodologies, and regulatory compliance
Qualification
Required
IT CSV Validation of IT systems
CQV Qualification of Equipment
Knowledge of regulatory frameworks (e.g., FDA 21 CFR Parts 11, 211, 820; along with industry standards (e.g., ISPE, GAMP 5)
Experience with Veeva Quality Docs, ServiceNow, JIRA and Kneat
Pharma industry experience is mandatory
Experience in authoring validation documents and managing validation projects
Lead and oversee multiple quality and validation projects
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
Company data provided by crunchbase