Sr. Director - Quality Assurance

Lilly • Indianapolis, IN

2d

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The Senior Director, IRLT Site Quality Leader is responsible for Quality Assurance and Quality Control for the manufacture of radioligand therapeutics at various stages of development and commercially approved products. This role leads all quality initiatives from defining quality objectives alongside site executive leadership, setting a quality culture, developing and managing staff, to designing the QMS, assuring inspection readiness and site performance, defining QA/QC responsibilities, supporting business goals and operational excellence, and strategically directing continuous improvement. The position partners with site leadership, corporate Quality Assurance, central and global functions across Lilly, and Manufacturing and Quality to effectively manage and fulfill these responsibilities.

Requirements

• Bachelor’s degree (BS/BA) in Science, Chemistry, or Life Science.
• 15+ years of cross-functional Quality experience supporting GMP manufacturing (Pharmaceutical, Biotech, or Medical Device industry).
• 10+ years of direct team management experience in Quality.
• Expert knowledge of cGMP requirements from early phase to commercially approved pharmaceutical products, analytical laboratory and quality control, quality audits, root cause investigations, and unique radiopharmaceutical controls.
• Demonstrated success leading multi-functional QA and QC teams and staff career development
• Highly experienced with inspection readiness, FDA and foreign regulatory authority inspections, quality remediation activities and regulatory inspections.
• Experienced with the design and continuous improvement of quality management systems.

Nice To Haves

• Skilled at problem solving, decision making, financial and resource management, and strategic planning in a dynamic environment.
• Proven ability to coach, mentor, and teach.
• Ability to manage globally impacting complex projects and shifting priorities.
• Strong stakeholder engagement and relationship-building skills.
• Proficiency in Microsoft Office (Outlook, Word, PowerPoint, Excel).

Responsibilities

• Ensure the design, compliance, and success of the site’s QMS in alignment with applicable regulatory guidelines and Lilly quality standards as appropriate for varying product lifecycles and unique characteristics of radiopharmaceuticals.
• Lead efforts to define radiopharmaceutical controls and expectations within the Lilly quality system
• Define and implement an adequate QA/QC organization, roles and responsibilities, and quality oversight
• Proactively evaluate and routinely inspect for potential failure modes within the QMS, define improvements, and assure robust controls for areas of risk. Lead, identify, escalate, and implement compliant risk-based solutions for quality related issues to Executive and corporate Quality Leadership.
• Ensure controls are established to implement, oversee and assure site performance, inspection readiness, and report performance to management
• Strategically identify and implement quality improvement plans aligned with corporate objectives for QA/QC and manufacturing success
• Host regulatory inspections and lead inspection support teams
• Collaborate with global teams to establish resources and solutions to drive effectiveness, efficiency, productivity, and assure radiopharmaceutical integration with the corporate quality system
• Foster strong collaborative relationships with stakeholders, including the site leadership team, business partners, vendors, and service providers.
• Coach and mentor quality staff to continuously strengthen technical and leadership capabilities.
• Serve as a member of the Site Leadership Team (SLT) and influence site strategy.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director