Sr. Director - Quality Assurance

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.

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 35,000 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.

Position Overview:

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.

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.

Basic Qualifications

• 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.

Additional Skills/Preferences:

• 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).

Additional Information:

• Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
• Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process, please email Lilly Recruiting Compliance. Please note, this email address is intended for use only to request a disability accommodation, please email Lilly Recruiting Compliance for further assistance. Inquiries which are not requests for accommodations may not receive a response.

 

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$156,000 - $253,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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