Sr. Director - Quality Assurance

Location: Indianapolis

Sr. Director - Quality Assurance page is loaded## Sr. Director - Quality Assurance locations:
US, Indianapolis INtime type:
Full time posted on:
Posted Todayjob requisition :
R-99522

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 life cycles 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…