Quality Validation Manager
Quality Validation Manager
Location: Greater Philadelphia area (onsite)
We're partnering with a global pharmaceutical manufacturing organization in the greater Philadelphia area to hire a Quality Validation Manager to oversee validation and qualification activities across manufacturing and laboratory operations.
This role sits within site Quality leadership and is responsible for ensuring GxP‑compliant validation lifecycle management while supporting new product introductions and inspection readiness.
Key responsibilities:
- Provide GxP oversight for validation and qualification of processes, equipment, utilities, facilities, and systems
- Lead validation lifecycle activities including protocol approval, reporting, and ongoing compliance
- Support new product introductions and technology transfers with quality oversight of validation deliverables
- Define and manage validation‑related change control requirements
- Oversee computerized system validation (CSV) and laboratory systems compliance
- Partner with Operations, Engineering, MSAT, and Product Quality to support site objectives
- Analyze validation data and trends to drive continuous improvement
- Serve as the site SME for validation during audits and regulatory inspections
Background requirements:
- Bachelor's degree in a scientific or engineering discipline (advanced degree a plus)
- 10+ years of experience in pharmaceutical or biotech manufacturing environments
- Strong hands‑on experience with process, equipment, and system validation
- Solid understanding of FDA, EMA, and ICH validation expectations
- Experience with continued process verification and validation master planning
- Proven ability to lead technical initiatives and influence cross‑functionally
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