Senior Director - Parenteral Operations

Role: Senior Director of Parenteral Operations overseeing GMP-compliant manufacturing processes for injectable medicines.

Responsibilities

• leading cross-functional teams to ensure safety, quality, and operational excellence
• implementing site strategies
• driving continuous improvement
• maintaining compliance with regulatory standards (FDA, EMEA, OSHA, EPA)
• supporting new product commercialization
• collaborating with external agencies during inspections

Requirements

• Bachelor's in Engineering, Life Sciences, or related field
• minimum 10 years of pharmaceutical manufacturing experience
• 5+ years of leadership in parenteral or aseptic production
• strong knowledge of quality systems, regulatory requirements, and operational standard(s) (e.g., OSSCE, CAPA, Lean)
• excellent interpersonal and judgment skills

Preferred

• Experience supporting aseptic operations
• allergens management
• regulatory interactions

HighValue: Aseptic parenteral manufacturing, GMP compliance, regulatory agency interaction, leadership in continuous improvement initiatives, site strategy development, cross-functional team management, and experience in a highly regulated injectable medicines environment.

Work Setup

Full-time onsite at Kenosha site, supporting personnel working in sterile environments, with necessary safety equipment and allergen considerations.

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