Robert Arnott

Bob brings more than 30 years of executive quality and compliance leadership to biopharma, gene therapy, and medical device clients. His expertise spans the full range of cGMP challenges — inspection readiness and health authority engagement (FDA, EMA, MHRA, Health Canada, and others), Warning Letter remediation, enterprise QMS design and harmonization, CDMO and supplier quality oversight, phase-appropriate quality frameworks for early-stage programs, and quality oversight of greenfield cGMP facility design, commissioning, and qualification. He has hosted multiple successful regulatory and notified body inspections, resolved two inherited FDA Warning Letters, and led global quality organizations of up to 1,200 professionals across 23 sites.

Before joining Dark Horse, Bob served as the Large Molecule plant quality lead within Eli Lilly's API External Manufacturing organization, supporting product quality and inspection readiness for a network of external drug substance manufacturers producing monoclonal antibodies, ADCs, and enzymes. Prior to Lilly, he was Senior Vice President and Chief Quality Officer at Jaguar Gene Therapy and its spinout CDMO Advanced Medicine Partners, where he built phase-appropriate GxP frameworks and the advancement of one program into Phase 1/2 clinical studies, secured first-pass IND approval with no CMC comments, and provided quality oversight of a greenfield cGMP manufacturing facility buildout.

Bob previously served as Senior Vice President of Quality Assurance and Regulatory Affairs at Vyaire Medical and Smith & Nephew, where he was recruited into enterprise-scale compliance transformation mandates — including the resolution of two inherited FDA Warning Letters and the harmonization of quality systems across 23 global sites. Earlier, as Vice President of Quality for U.S. Pharma Operations at Hospira (acquired by Pfizer), he led inspection readiness across five manufacturing sites producing biologics, sterile injectables, and DEA-controlled substances. His earlier leadership experience at Baxter Healthcare, Pfizer, and Alkermes included site quality oversight, global supplier quality leadership, and quality governance of greenfield cGMP facility design, commissioning, and qualification.

Eli Lilly and Company API External Manufacturing QA – Large Molecules

Advanced Medicine Partners Chief Quality Officer

Jaguar Gene Therapy Senior Vice President

Vyaire Medical, Inc. Senior Vice President, Quality Assurance & Regulatory Affairs

Smith & Nephew, Inc. Senior Vice President, Quality Assurance & Regulatory Affairs

Hospira, Inc. (acquired by Pfizer) Vice President, Quality – U.S. Pharma Operations

Baxter Healthcare Corporation Senior Director, Global Supplier Quality / Site QA Leader

Pfizer, Inc. Director, Quality Assurance Senior Manager, Quality Assurance

Alkermes, Inc. Manager, QA Tech Services & Compliance

Loyola University of Chicago B.S. in Biology — Focus: Molecular Biology / Genetic Engineering