Senior Manager / Associate Director, Validation

Role Summary

The Sr. Manager/Assoc. Director, Validation, leads the Validation group in MSAT and is accountable for Raleigh’s overall validation program for equipment, facilities and utilities, control and/or data recording systems, and Process Performance Qualification. Ensures that validation approaches are aligned with industry standards (cGMPs, GAMP 5, ISPE guidelines, ICH guidelines) and maintains strong working knowledge of FDA/EU regulatory requirements and data integrity guidance. Interfaces closely with Quality Assurance and equipment/system/area owners across Facilities/Metrology, Manufacturing Operations, Quality Control laboratories, Supply Chain/Warehouse, and IT/CSV, and collaborates globally to design and execute PPQ campaigns for pivotal programs.

Responsibilities

• Own the Raleigh Site Validation Master Plan
• Ensure compliance with industry- and agency-recognized norms – cGMPs, GAMP 5, ISPE guidelines, ICH guidelines
• Optimize and rationalize the approach to equipment/systems onboarding (impact assessments), initial qualification, and periodic requalification
• Manage the writing of validation protocols, work with direct reports and equipment/system owners to ensure protocol execution, and manage the completion of summary reports
• Ensure that CSV SMEs are supporting all equipment owners (including IT systems) in meeting GAMP 5 standards and completing data integrity assessment and validation of GxP software
• Establishes minimal standards for risk assessments of control, automation, and data recording systems and drives work to mitigate compliance gaps
• Partners with Regulatory, Quality, and MSAT/Process Sciences to establish PPQ campaign design to ensure successful product registration (BLA submissions)
• Establishes phase-appropriate validation concepts for single-use systems beyond aseptic qualifications, for example leachable/extractable evaluations and contracted studies as necessary
• Ensures rigorously applied appropriate technical standards for processing, packaging, and materials, where applicable, employing new/modern processes and technologies (Quality by Design, Design of Experiment, Process Analytical Technologies)
• Key member of the Raleigh SLT

Qualifications

• 8–12 years’ experience in validation, with 2–4 years of direct manager experience
• Proven success in delivering outstanding results
• Strong working knowledge of regulatory standards and guidances on validation in the pharma/biopharma industry, as well as ISPE and PDA guidances
• Expert working knowledge of cGMPs and GAMP5

Education

• Bachelors or Masters in biological or chemical sciences, Chemical Engineering, Pharmacy, Pharmaceutical Technology, or related field. Ph.D. desirable.

Skills

• Exemplifies teamwork across the organization and ensures that collaborative efforts are managed effectively
• Recognized as a subject matter expert in facilities/equipment/control systems validation as well as process validation lifecycle
• Demonstrates Cellectis’ values, acts as a role model for others, and constantly fosters a positive work environment
• Highly effective at operating in a complex or matrixed environment