Senior Director Quality

Bend Bioscience is looking for a Senior Director of Quality. In this role, you will lead, organize, and oversee daily Quality Assurance and Quality Control operations in Georgia to ensure compliance with U.S. pharmaceutical manufacturing standards and applicable global regulations. You will direct the Quality Assurance team ensuring the effective execution of quality systems, including product release, site audits, CAPAs, change control, investigations, and deviations. The ideal candidate will oversee the Quality Control laboratories, ensuring accurate and timely testing of raw materials, in-process samples, finished products, microbiology, stability studies, and method validation activities. You will drive operational excellence and regulatory compliance across all quality functions.

At Bend Bioscience, our core values shape how we work, lead, and grow together.
We are a High Science, High Service, people-centered company committed to advancing human health. Our team thrives on being authentic, curious, and accountable, while staying flexible, collaborative, and driven by care. We blaze trails by challenging the status quo, pursuing excellence in everything we do, and maintaining relentless focus on delivering real impact.

Whether you are in the lab, on the floor, or behind the scenes, your work at Bend Bioscience will matter. You will join a team that values continuous learning, bold thinking, and doing the right thing—even when it is hard.

How You Will Make an Impact:

Leadership Functions (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.

Essential Functions (Responsibilities):

• 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.
• Professional Conduct and Workplace Culture: Ensure full-time attendance, exhibit professionalism with business associates, and align daily actions with organizational values.
• Performs all other duties as assigned.

What You Will Bring to the Role:

Education:

• Minimum Required: Bachelor's in Chemistry or related field

Experience:

• Minimum Required: 15 plus in pharmaceutical Quality Assurance, Operational Quality Control, Risk Management, and Regulatory Affairs.
• Required People Management: 8 plus years
• Preferred: Background that includes Chemistry, Analytical Chemistry, Biochemistry or Biology.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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