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 a Manager, Quality Field - Quality Assurance to manage a team of Quality Analysts to ensure cGMP compliance for site operations, including operations on the manufacturing floor, within Quality Control laboratories, dispensary and within site warehouses.

• Manages cross functional team of up to eight personnel covering manufacturing operations on a 24-hour 7-day basis.
• Supervises and executes operating procedures for the site Quality Assurance program that ensures real time monitoring, verification of procedural and safety compliance, executed manufacturing batch record review, and inspection readiness.
• Responsible for critical Quality decisions on the manufacturing floor concerning continued processing of drug substance.
• Responsible for providing Quality field representation and updates at daily Tier 2/3 meeting.
• Provides oversight of QC labs, dispensary and warehouse off hours on weekends and holidays.
• Provides quality oversight of manufacturing activities on a day-to-day basis.
• Provides coverage for change control and document control during off-hours, holidays and weekends.
• Provides oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensures program management complies with site and corporate procedures.
• Contributes to and supports the site team, which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
• Directly participates in internal audits or reviews as well as global health authority inspections. Includes representation on inspection response and CAPA teams.
• Hires, integrates and develops high quality talent, capable of delivering against the department’s goals and objectives.
• Establish and communicates performance objectives for Quality Assurance field staff that are consistent with the Quality and business unit goals.
• Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment, which enhances unit performance and integration across site departments.
• Act as a Quality lead on projects within the GMP areas. Provide Quality oversight and release of areas to a GMP state.

• Knowledge of biologics Manufacturing, Drug Substance or Drug Product and batch record review is highly desirable.
• Knowledge of US and EU cGMP regulations and guidance.
• Knowledge of electronic systems including any of the following: SAP, LIMS, and TrackWise is desirable.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics manufacturing with direct accountability for final product release.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.
• Knowledge in Operational Excellence and Continuous Improvement is desirable.
• Demonstrated leadership, interpersonal, communication, and motivation skills is required.
• Demonstrate appropriate examples for compliance behaviors and attitudes, thereby shaping the culture.
• Effective interaction with all contacts and the ability to work in a team-based environment and interact well with other employees at various levels.

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.