Bend Bioscience ยท 5 hours ago
Senior Director Quality
Gainesville, GA
Full-time
Onsite
Director/Executive
15+ years expBend Bioscience is looking for a Senior Director of Quality to lead and oversee daily Quality Assurance and Quality Control operations. The role involves ensuring compliance with U.S. pharmaceutical manufacturing standards and directing the Quality Assurance team for effective execution of quality systems.
Pharmaceuticals
Responsibilities
Provide strategic and day-to-day leadership of the site Quality departments, fostering a culture of continuous improvement through coaching, mentoring, and team engagement
Set clear performance standards and support employee growth through goal setting, delegation, continuous feedback, and performance management. Ensure alignment with company organizational goals and regulatory expectations
Identify, recruit, and retain high-performing talent while promoting a diverse, inclusive, and development-focused team culture
Maintain transparent communication and provide consistent oversight in alignment with organizational policies through meetings and regular interpersonal engagement
Lead the development, implementation, and oversight of regulatory and quality compliance standards to ensure all products meet corporate, customer, and regulatory requirements for quality, safety, and efficacy
Manage Site Risk Register to ensure all potential compliance risks are identified and assessed, and appropriate corrective/preventive actions are implemented
Direct Quality Control (QC) and liaise with the Florida Microbiological testing operations, authorizing the release of raw materials, in-process and finished products, and environmental monitoring data to support clinical and commercial manufacturing
Review and approve change controls, investigations, corrective and preventive actions (CAPAs), and release-related documentation, coordinate with Document Control and customers per quality agreements
Define and execute continuous quality and cost improvement initiatives, using science- and risk-based assessments to manage product and process changes effectively
Establish and monitor Key Performance Indicators (KPIs) to track quality objectives, identify trends, and report progress to site and company leadership
Liaise with the MS&T/Analytical Development group to ensure method validations and method transfers are effective to ensure compliance with Good Manufacturing Practices (GMP) and meet client testing needs
Manage the site stability program to ensure accurate, timely, and robust processes for product stability testing
Support and participate in internal and external audits, including customer and regulatory inspections; prepare audit reports, respond to observations, and assist with regulatory submissions as needed
Ensure full-time attendance, exhibit professionalism with business associates, and align daily actions with organizational values
Performs all other duties as assigned
Qualification
Required
Bachelor's in Chemistry or related field
15 plus years in pharmaceutical Quality Assurance, Operational Quality Control, Risk Management, and Regulatory Affairs
8 plus years of people management experience
Preferred
Background that includes Chemistry, Analytical Chemistry, Biochemistry or Biology
Company
Bend Bioscience
Bend Bioscience is a highly experienced contract development and manufacturing organization (CDMO) dedicated to advancing pharmaceutical innovation through cutting-edge scientific expertise and flexible problem-solving.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Ajay Damani
Chief Executive Officer
David Vodak
Chief Science Officer
Company data provided by crunchbase