Stephen Jackowell

About Stephen Jackowell

I am an experienced Quality and Compliance Leader with 17+ years of expertise in sterile & non-sterile biopharma and API manufacturing (animal health). Other than a short-term assignment in Winslow, Maine, my career has been based at a single high-throughput site, where I developed broad expertise across Quality, Validation, Manufacturing, and CQV. I have led site-wide Quality functions, directed parenteral filling and aseptic operations, and managed complex validation programs, consistently delivering results under FDA, USDA, EU, and VMD regulatory frameworks.I am actively seeking hybrid contract/consulting work in the U.S.(up to 75% travel) or permanent on-site roles in Central Iowa. While I have held senior director-level leadership positions, I welcome opportunities at all levels of management and consulting in the life sciences industry. I bring extensive management experience in highly competitive and demanding environments, with proven strengths in quality systems, validation, GMP compliance, and facility expansion. Known for hands-on leadership and a collaborative approach, I consistently deliver results under pressure.At Elanco, I served as Site Head of Quality and later Director of Biological Manufacturing Operations, leading Quality, Validation & Manufacturing teams. My leadership included USDA remediation programs, global Quality Management Systems development and alignment, and multi-week regulatory inspections with zero major findings. I also managed large-scale operations, reducing backorders by 75%, restructuring filling operations to 24/7, and increasing capacity by 25% while maintaining compliance in unionized environments.My technical expertise includes vaccine and API aseptic parenteral filling (large/small volume, lyophilization), sterilization systems, large-scale formulation and blending, and cleanroom facility compliance. I served as CQV lead for a $32M, sq. ft. EU-compliant parenteral filling expansion with aseptic suites, IMA freeze dryers, automated filling lines with RABS, and steam sterilizers. I also partnered directly with Eli Lilly on a $43M site consolidation and technology transfer, overseeing project quality and compliance as well as CQV activities for blending, fermentation, and VHP-capable suites.With a track record of regulatory success, validated facility startups, and senior-level Quality and Manufacturing leadership, I am recognized for integrating technical depth with strategic oversight, delivering efficient, sustainable results in regulated environments.

Experience

1. Head of Validation & Cqv Strategy

   Diamond Animal Health, Inc

   Dec 2025 — Present · Des Moines, IA, US

   Leading redevelopment and modernization of the validation strategy, programs, and documentation for a fast-growing CDRMO supporting USDA-licensed biologics, FDA-regulated pharmaceuticals, and DEA-controlled products.Responsible for building a harmonized, risk-based validation framework aligned with current regulatory expectations, industry best practices, and the company’s expanding manufacturing capabilities.Focus areas include CQV lifecycle management, process and cleaning validation, computerized system validation, and integration of quality risk management (QRM) principles to drive compliance, consistency, and operational excellence across the site.Partnering cross-functionally with Quality, Engineering, Operations, and Regulatory teams to ensure a state of control, inspection readiness, and scalability as the organization continues to grow.

Education

• Iowa State University

  Bachelor of Science (BS), Business Management and Applied Sciences

  1995 — 1998

• Iowa Central Community College

  Associate of Arts (A.A.), Business/Commerce, General

  1993 — 1995

Skills

• Microsoft Office
• Microsoft Excel
• Microsoft Word
• Powerpoint
• Customer Service
• English
• Photoshop
• Windows
• Outlook
• Public Speaking
• Editing
• Strategic Planning
• Gmp
• Sop
• Change Control
• Fda
• Gxp
• Validation
• Aseptic Processing
• Capa
• 21 Cfr Part 11
• Quality Assurance
• Pharmaceutical Industry
• Regulatory Requirements
• Verification and Validation (V&V)
• Cleaning Validation
• Management
• Cross-Functional Team Leadership
• Pharmaceutics