Associate Director - Engineering and Computer Systems Quality – Lilly Medicine Foundry

BioSpace; Indianapolis (IN); On-site; USD 118,000 - 174,000; Full time

Job summary

A leading company in the biopharmaceutical industry is seeking an Associate Director of Engineering and Computer Systems Quality. This role involves overseeing quality for facilities and systems at a new state-of-the-art research facility, leading a QA team, and ensuring compliance with quality standards during the construction and operation phases.

Benefits

401(k)

Pension

Health insurance

Flexible spending accounts

Life insurance

Paid time off

Well-being programs

Qualifications

• 5+ years in technical or quality roles within the biopharmaceutical industry.
• Experience with large-scale capital projects preferred.

Responsibilities

• Lead and develop a team of QA professionals.
• Support cross-functional teams and establish KPIs.
• Communicate effectively with stakeholders.

Skills

Data integrity

Computer system validation

SDLC

Project management

Leadership

Problem-solving

Communication

Relationship-building

Education

BA/BS in Engineering or related field

Job description

Associate Director - Engineering and Computer Systems Quality – Lilly Medicine Foundry

Join to apply for the Associate Director - Engineering and Computer Systems Quality – Lilly Medicine Foundry role at BioSpace

Associate Director - Engineering and Computer Systems Quality – Lilly Medicine Foundry

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Join to apply for the Associate Director - Engineering and Computer Systems Quality – Lilly Medicine Foundry role at BioSpace

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 work worldwide to discover and deliver medicines, improve disease understanding, and support communities through philanthropy and volunteerism. We prioritize people and strive to make a positive impact.

Overview
Lilly is constructing the Lilly Medicine Foundry in Lebanon, IN, a state-of-the-art research facility for API production for clinical trials. This greenfield site is a significant investment in clinical trial manufacturing, aiming to support current and future products, including new modalities. This role offers a unique opportunity to be part of the startup team, helping to establish processes and operations for GMP manufacturing.

Position Summary
The Associate Director of Engineering and Computer Systems Quality will oversee Quality for Facilities, Utilities, Maintenance, Equipment, and Computer Systems at the Foundry. The role involves supporting the digital strategy, ensuring quality standards during design and construction phases, and coordinating with cross-functional teams to meet project timelines.

Responsibilities & Scope

• Lead and develop a team of QA professionals, including coaching and recruiting.
• Support cross-functional teams, facilitate decision-making, and establish KPIs.
• Forecast resource needs and proactively resolve potential issues.
• Communicate effectively with stakeholders and manage issues proactively.
• Promote a culture of quality and participate in global communities of practice.
• Evaluate and approve changes related to computer systems and quality processes.
• Lead process improvement initiatives impacting multiple areas.

Basic Qualifications

• BA/BS in Engineering or related field
• 5+ years in technical or quality roles within the biopharmaceutical industry
• Experience with large-scale capital projects is preferred.

Key Attributes

• Knowledge of data integrity, computer system validation, and SDLC
• Experience overseeing facilities, utilities, and validation efforts
• Strong project management and leadership skills
• Ability to adapt to a dynamic environment and influence decision-making
• Proven ability to innovate and improve processes
• Excellent communication and relationship-building skills
• High learning agility and problem-solving skills

Lilly is committed to diversity and inclusion, providing accommodations for applicants with disabilities. For assistance, complete the workplace accommodation form. We are an equal opportunity employer, valuing diversity in our workforce.

Compensation is based on education, experience, and location, with an estimated range of $118,500 - $173,800. Benefits include a 401(k), pension, health insurance, flexible spending accounts, life insurance, paid time off, and well-being programs. The company reserves the right to modify these programs as needed.