CSL Validation Lead

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: CSL Validation Lead

Location(s): King of Prussia, PA

(Remote)

Qualifications:

• 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 artifacts).
• 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.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.