Sr. Manager - QA Assurance

Location: Triangle

Sr. Manager - QA Assurance page is loaded## Sr. Manager - QA Assurancelocations:
US:
Research Triangle Park NCtime type:
Full time posted on:
Posted Todayjob requisition :
R-98711

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 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.
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* Position Overview:

** Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future.  As a result, Lilly is looking for experienced Quality Assurance Manager to support our growth in Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.
** Position

Description:

** The Senior Manager, Quality Assurance is responsible for providing leadership and technical oversight for the formulation, filling, and visual inspection areas to ensure compliance with regulatory requirements, corporate standards, and industry best practices.

This role combines people management with technical quality expertise, driving team structuring, collaborators development, continuous improvement of regulated processes, documentation, and operational readiness.

The Manager/Senior Manager will help build a strong quality culture, lead inspection readiness, and provide ongoing operational support.
** Management Responsibilities
*** Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence.
* Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement.
* Establish and monitor performance objectives, providing feedback and coaching to drive team development.
* Identify business and quality risks, escalating appropriately and in a timely manner.
** Technical Responsibilities
*** Provide continuous quality improvement oversight to regulated processes, practices, and documentation.
* Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements.
* Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues.
* Work cross-functionally with process teams for metrics reviews, operational support, and deviation management.
* Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance.
* Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings.
* Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines.
* Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes.
* Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions.
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* Minimum Requirements:

*** Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field.
* 5+ years of experience in Quality Assurance, with at least 3 years in a leadership role.
* Demonstrated strong experience and…