Senior Manager / Associate Director, Validation
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Role Summary
Senior Manager / Associate Director, Validation – leads the Validation group in MSAT and is accountable for Cellectis Raleigh’s overall validation program for equipment, facilities and utilities, control and/or data recording systems, and Process Performance Qualification. Ensures validation approaches align with industry standards (cGMPs, GAMP 5, ISPE, ICH) and regulatory guidance including Data Integrity. Interfaces with Quality Assurance, Facilities/Metrology, Manufacturing Operations, Quality Control, Supply Chain/Warehouse, IT/CSV, and works globally with Quality, Regulatory Affairs, Process and Analytical Development, MS&T, and Manufacturing Operations to design and execute PPQ campaigns for pivotal programs.
Responsibilities
- Ownership of the lifecycle validation approach for equipment (and associated control/data recording systems), controlled areas, and clean utilities.
- Owns 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
- Establish minimal standards for risk assessments of control, automation, and data recording systems and drive work to mitigate compliance gaps
Process validation / Process Performance Qualification
- 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, including leachable/extractable evaluations and contracted studies as necessary
- Ensures rigorously applied appropriate technical standards for processing, packaging, and materials, employing new/modern processes and technologies (e.g., Quality by Design, Design of Experiment, Process Analytical Technologies)
Education And Experience
- Bachelor’s or Master’s in biological or chemical sciences, Chemical Engineering, Pharmacy, Pharmaceutical Technology, or related field. Ph.D. desirable.
- 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
Technical Skills Requirements / Core Competencies
- 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 values, acts as a role model for others, and fosters a positive work environment.
- Highly effective at operating in a complex or matrixed environment.