Manager, QA Validation (Sterile Manufacturing)

Position Overview

The QA Validation Manager manages the validation activities supporting sterile drug product manufacturing and fill–finish operations. This role ensures that validation/qualification program/activities meet regulatory expectations and maintain a state of control across aseptic processing areas. The ideal candidate brings strong technical expertise in validation, proven project and people management skills, and deep understanding of sterile manufacturing and fill–finish processes. Adheres to quality and safety policies and procedures.

Key Responsibilities

Validation and People Management
Develop risk-based qualification/validation strategy to support the activities
Support generation, review and approval of validation deliverables such as plans, protocols and reports (supporting equipment, facility, utility, computerized systems and processes)
Supervise validation engineers/specialists (direct or contract) ensuring high technical competency and adherence to cGMP.

Aseptic & Fill–Finish Support
Provide QA oversight for validation activities including process validation, cleaning validation, equipment qualification (IQ/OQ/PQ), utility qualification, and computer system validation.
Oversee validation activities related to aseptic processing, sterilization (e.g., autoclaves, dry heat ovens), and environmental monitoring systems.
Evaluate and support qualification of cleanrooms, HVAC systems, compressed gases, WFI, and clean steam.
Participate in aseptic process simulations (media fills) and ensure validation readiness.
Support validation of formulation processes, sterile filtration, container closure systems, and visual inspection technologies.
Assess validation impact for changes to equipment, components, formulations, or process parameters.
Identify opportunities to optimize fill–finish validation strategies while maintaining compliance and product quality.
Contribute to development and revision of SOPs, templates, and quality standards related to aseptic processing and fill–finish validation.

Quality Systems and Compliance
Apply Quality Risk Management (ICH Q9) principles to validation strategies and decisions.
Support investigations related to validation deviations, equipment failures, or sterility assurance risks
Ensure validation activities align with FDA, EMA, ICH, Annex 1, and industry best practices for sterile and fill–finish operations.
Support regulatory inspections and internal audits, serving as the subject matter expert for validation.

Required Qualifications/Skills

Bachelor’s or master’s degree in engineering, Life Sciences, or related field.
8+ years of experience (6+ years for master’s degree) in validation/QA within a GMP sterile manufacturing or fill–finish environment.
3+ years of experience in people management (direct or contract)
Strong understanding of aseptic processing, sterilization, contamination control, fill–finish and packaging operations.
Working knowledge of validation lifecycle principles, risk management, and data integrity requirements.
Familiarity with regulatory expectations including FDA, EMA, ICH Q7–Q10, and EU Annex 1.
Excellent communication, documentation, and cross functional collaboration skills.

Preferred Qualifications
Experience with isolator‑based sterility testing and aseptic filling technologies.
Experience supporting regulatory inspections (FDA, EMA, MHRA).
Lean/Six Sigma or continuous improvement training.