Katalyst CRO · 3 months ago
CSL Validation Lead
King of Prussia, PA
Contract
Onsite
Senior Level, Lead/Staff
15+ years expKatalyst CRO is a company focused on pharmaceutical IT solutions, and they are seeking a CSL Validation Lead. The role involves overseeing validation processes, defining validation strategies, managing risk and compliance, and providing guidance to teams on regulatory standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
15+ years of experience in Pharma IT and SAP environments
Strong knowledge of CSV, GxP, and regulatory frameworks
Proven leadership in quality assurance and validation
Validation Oversight: Author and approve key validation deliverables (e.g., Deliverable Scaling Assessment, CRs, lifecycle documents, test artefacts)
Strategic Quality Leadership: Define validation strategies with SMEs; assess impact on product quality and data integrity
Risk & Compliance Management: Lead and contribute to risk assessments (GxP, cybersecurity, data privacy); ensure validated state and operational compliance
Team Guidance & Mentorship: Advise teams on SOPs, CSV processes, and regulatory standards; foster quality culture and process excellence
Audit & Supplier Engagement: Support internal/external audits; lead audit activities for GxP systems; perform supplier assessments
Qualification
Required
15+ years of experience in Pharma IT and SAP environments
Strong knowledge of CSV, GxP, and regulatory frameworks
Proven leadership in quality assurance and validation
Validation Oversight: Author and approve key validation deliverables (e.g., Deliverable Scaling Assessment, CRs, lifecycle documents, test artefacts)
Strategic Quality Leadership: Define validation strategies with SMEs; assess impact on product quality and data integrity
Risk & Compliance Management: Lead and contribute to risk assessments (GxP, cybersecurity, data privacy); ensure validated state and operational compliance
Team Guidance & Mentorship: Advise teams on SOPs, CSV processes, and regulatory standards; foster quality culture and process excellence
Audit & Supplier Engagement: Support internal/external audits; lead audit activities for GxP systems; perform supplier assessments
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