Senior Manager, Quality Control (Small Molecules)

Join Otsuka America Pharmaceutical Inc. in Uptown, Marion County as a Senior Manager, Quality Control (Small Molecules), where you'll lead analytical and laboratory operations for pharmaceutical drug manufacturing in a full-time position.

About the Role

As Senior Manager of Quality Control for Small Molecules at Otsuka America Pharmaceutical Inc., you'll oversee the analytical laboratory functions that support GMP-compliant manufacturing, product release, and regulatory submissions. This leadership role combines strategic planning with hands-on direction of QC teams, ensuring that every small-molecule pharmaceutical meets rigorous quality standards before reaching patients.

What You'll Do

• Direct and manage the quality control laboratory team responsible for testing drug substances and finished drug products
• Establish and enforce analytical testing protocols, methods validation, and quality assurance procedures for small-molecule compounds
• Oversee product release decisions, ensuring compliance with GMP regulations and company standards
• Coordinate with regulatory affairs, manufacturing, and development teams on analytical requirements and submissions
• Implement continuous improvement initiatives to enhance laboratory efficiency, turnaround time, and data integrity
• Lead regulatory interactions, including FDA inspections and responses, for quality control functions
• Manage laboratory budgets, equipment maintenance, and staffing decisions
• Champion a culture of quality and compliance across the laboratory and manufacturing operations

What We're Looking For

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related field; advanced degree preferred
• 10+ years of experience in pharmaceutical quality control or analytical chemistry, with at least 5 years in a supervisory or managerial capacity
• Demonstrated expertise in small-molecule analytical testing, HPLC, and related techniques
• Strong knowledge of GMP regulations, FDA guidelines, and pharmaceutical quality standards
• Proven ability to lead, mentor, and develop laboratory teams
• Excellent communication skills and experience interfacing with regulatory bodies
• Experience with laboratory information management systems (LIMS) and data integrity

About Otsuka America Pharmaceutical Inc.

Otsuka America Pharmaceutical Inc. is committed to discovering, developing, and delivering innovative pharmaceutical solutions that improve patient health. Based in the Marion County area, we manufacture and release quality medications that serve patients across the United States.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.