We are LOTTE Biologics! A new company, built on 80 years of tradition!

We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

We deliver therapies that make a Healthier World!

To help us meet our mission LOTTE Biologics is in need of an Associate Director, Quality Systems IT to lead a team accountable for the support, enhancement and maintenance of all site and global quality applications, as well as the delivery of computer system validation and IT compliance within LOTTE Biologics. The Associate Director, Quality Systems IT plays a critical role in managing the delivery of Quality IT solutions across the organization. This role will partner with functional leadership throughout the LOTTE Biologics organization to develop and execute against strategic IT roadmaps in the quality space, working to realize shared end goals across the IT landscape.

• Lead an IT organization that has responsibility for Benchtop Administration, Quality Systems, Computer System Validation (CSV) and IT Compliance
• Grow and develop manager capabilities within the Quality IT management team
• Collaborate with Site Stakeholders and leadership to develop, support and align strategies for Quality IT systems
• Own end-to-end responsibility for key applications, ensuring they are reliable, accessible, secure, and comply with applicable regulatory requirements.
• Design technical solutions and define roadmaps for Quality IT in line with digital plant roadmap, business roadmap & global IT strategy, focusing on speed, quality, & cost
• Manage Total Cost of Ownership and the key drivers behind them to ensure approach is cost efficient
• Influence vendor roadmaps to align with LOTTE Biologics strategy
• Develop a high performing team within the Quality IT organization, ensuring employee satisfaction, engagement, and productivity

• BS in related technical field or equivalent applicable experience
• Experience managing high-performing teams in a regulated environment
• Greater than 5 years of experience in an IT leadership position
• Experience overseeing and collaborating with external partners and vendors
• Experiencing managing a portfolio of application to budget across their lifecycle

Specific Knowledge, Skills, Abilities, etc:

• Demonstrated effective leadership skills in building high performing teams
• Deep knowledge of regulatory requirements in the areas of computer system validation, data integrity, and 21CFR Part 11.
• Knowledge and understanding of pharmaceutical quality control processes
• Knowledge and understanding of Quality Management Systems and Frameworks
• Knowledge and understanding in SDLC and ITIL
• Ability to effectively lead and manage change throughout an organization
• System and business analysis skills

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities.  If this is the work that you want to do in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today! 

http://www.lottebiologics.com/

LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea. LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, as of January 1, 2023!

The newly established organization aims to become a Global Top 10 CDMO company in the biopharmaceutical industry.  With initial operations in 1948 in Japan, LOTTE has grown to become the fifth-largest conglomerate corporation in South Korea. LOTTE has various business units, including petro/fine chemicals, food, retail, hotels, electronics, construction, and IT. LOTTE has 30+ global locations across the US, Europe, and Asia.

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.