Associate Director - Quality - (QC – Endo Micro)

Position Overview

The Associate Director – Quality Control – Endo Micro is part of the Lilly Houston API QC team for the Lilly Houston API site. The role 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 will coach technical staff, prioritize routine production support activities, implement technical projects, and optimize processes. The position requires knowledge of cGMPs, global regulatory manufacturing guidance, and corporate/industry validation standards. The role works cross‑functionally within the site, network, and commercialization teams to deliver on technical objectives and quality objectives.

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 a scientific discipline such as Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or a related field.
• 5+ years 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.
• Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F‑1 CPT, F‑1 OPT, F‑1 STEM OPT, J‑1, H‑1B, TN, O‑1, E‑3, H‑1B1, or L‑1.

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 change, team spirit and flexibility.
• Demonstrated ability to learn & apply technical/scientific knowledge.

Additional Information

Minimal travel (<10%) may be required. Some off‑shift work (nights/weekends) may be required to support 24/7 operations.

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.

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.

Compensation and Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 – $198,000.

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 401(k) participation, pension, vacation benefits, medical, dental, vision, prescription drug benefits, flexible benefits such as 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 at 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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