Senior Manager / Associate Director, Validation

POSITION SUMMARY
The Sr. Manager/Assoc. 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 (“process validation”). Ensures that validation approaches are consistent with industry standards (cGMPs, GAMP 5, ISPE guidelines, ICH guidelines). Strong working knowledge and practical approach to FDA/EU regulatory requirements and guidance documents, including Data Integrity.

Interfaces closely with Quality Assurance and with equipment/system/area owners in Facilities/Metrology, Manufacturing Operations, Quality Control laboratories, Supply Chain/Warehouse, and IT/CSV to ensure that initial qualifications and periodic requalifications are robust and meet industry standards. Also works globally with Quality, Regulatory Affairs, Process and Analytical Development, MS&T, and Manufacturing Operations to design and execute the Process Performance Qualification campaigns for pivotal programs.

POSITION 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

• Ensures compliance with industry- and agency-recognized norms – cGMPs, GAMP 5, ISPE guidelines, ICH guidelines

• Optimizes and rationalizes the approach to equipment/systems onboarding (impact assessments), initial qualification, and periodic requalification

• Manages the writing of validation protocols, works with direct reports and equipment/system owners to ensure protocol execution, and manages the completion of summary reports

• Ensures 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

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, 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 (e.g. Quality by Design (QbD), Design of Experiment (DOE) and Process Analytical Technologies (PAT))

Key member of the Raleigh SLT

EDUCATION AND EXPERIENCE

• Bachelors or Masters 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 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.