Associate Director - Quality - (QC – Endo Micro) at Lilly

Houston, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

16 May, 26

Salary

198000.0

Posted On

15 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Leadership, Performance Management, Training, Development Of Staff, Gmp Compliance, Technical Review, Investigations, Change Controls, Regulatory Submissions, Validations, Process Control, Yield Improvement, Efficiency Improvement, Productivity Improvement, Project Management, Strategic Thinking

Industry

Pharmaceutical Manufacturing

Description

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. Organization Overview: 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 40,000 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 it 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. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Main Purpose and Objectives: The Associate Director – Quality Control is part of the Lilly Houston API QC team for the Lilly Houston API site. The Associate Director QC – Endo Micro provides technical leadership and expertise in the development, performance, and maintenance of the Small Molecule Head Block Lab throughout the start-up, implementation, and day-to-day operations of Houston. The Associate Director QC – Endo Micro must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The ideal candidate will work cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives. In the project delivery and start-up phase of the Houston site (2026 to 2027), The Associate Director QC – Endo Micro will be flexible in supporting project delivery, building a new organization, developing and implementing the necessary systems and business processes required to support GMP operations, and building the site culture. This will require significant collaboration, creativity, and resilience as the site grows to a full-scale GMP manufacturing operation. Key Responsibilities: · Provide technical leadership, performance management, training and development of staff · Maintain a safe work environment · Ensure GMP compliance · Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc. · Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives · Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits · Ensure adequate oversight and technical excellence for investigations and complaints · Collaborate with QC team to develop the strategy for the technical agenda to improve process control, yield, efficiency and productivity for all products within the site portfolio · Provide oversight for technical projects to improve process control, capacity, yield, and quality · Ensure adequate technical representation and engagement within the site and network governance meetings to influence technical agendas · Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites · Engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization Minimum Requirements: · Bachelor’s Degree in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or a related field · 5+ of experience in Quality Control and team leadership in a pharmaceutical manufacturing environment (API Preferred) · Extensive knowledge of a variety of analytical methods (e.g., LC, GC, KF, spectroscopy) related to pharmaceutical production of small molecules & Oligonucleotides Additional Preferences: · Ability to influence and lead diverse groups · Experience with complex regulatory, business, or technical issues for pharmaceutical manufacturing · Strong analytical and quantitative problem-solving skills · Experience with Empower software · Experience with Process Analytical Technologies · Experience with LIMS implementation and use within a manufacturing environment · Experience with statistical analysis of data · Technical leadership, administrative and organizational skills · Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional · Demonstrated Project Management skills and ability to coordinate complex projects · Ability to communicate and influence effectively across functional groups and stakeholders · Strategic thinking and ability to balance short term needs with long term business evolution · Ability to build relationships with internal and external customers and partners · Enthusiasm for changes, team spirit and flexibility · Demonstrated ability to learn & apply technical/scientific knowledge Additional Information: Minimal travel (

Responsibilities

The Associate Director QC – Endo Micro will provide technical leadership and expertise for the Small Molecule Head Block Lab during the startup and day-to-day operations of the Houston API site, balancing staff coaching, production support, project implementation, and process optimizations. Key duties include ensuring GMP compliance, technical review/approval of critical documents, partnering across functions to meet quality objectives, and providing oversight for investigations and technical projects.