We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World.

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.

Position Summary

The Sr. Manager QA Program Lead is responsible for providing Quality Assurance technical expertise and guidance to internal and external customers during new product introduction and technical transfer activities as well as for established existing customers. The Sr. Manager will serve as the main Quality contact for clients and is expected to interact directly and often with clients, especially with client Quality representatives. The Sr. Manager will be responsible for negotiating with clients to generate the Quality Agreement and ensuring compliance with its requirements, including providing client notifications as required.

In addition, the Sr. Manager will oversee client-specific change control activities, including record and action approval as needed. This role will also provide oversight and approval of site deviations, as well as on-the-floor Quality support as needed to ensure compliant and efficient operations. The Sr. Manager is also expected to support additional site needs as required to ensure overall Quality and operational success.

Duties & Responsibilities

Leads and provides management oversight to the QA Program Teams.
Represent Quality Assurance on New Product Introduction teams by directly interfacing with client, serving as decision maker and Quality SME
Accountable for ensuring deviation investigations are based on sound scientific rational and appropriate actions are taken to prevent recurrence.
Ensures that all QA Program Team personnel have adequate training, education and experience to perform their GMP related job function effectively.
Provide quality oversight of start-up activities including approval of master and executed production batch records and associated process documentation.
Communicates complex information clearly and concisely demonstrating knowledge of quality and compliance
Coordinate activities across the Quality organization to ensure success of new product introduction projects
Serve as main point of communication for established clients, providing necessary notifications on Quality related topics as required by the Quality Agreement
Generate, review and approve Quality Agreements with new clients, engaging in negotiations with client to determine key Quality interactions
Serve as contact for Client Quality PIP, escorting as needed and engaging, as necessary, during Quality visits from clients
Oversee and manage client- specific change control activities, including impact assessments, record and action approvals, and ensuring appropriate client involvement and approvals.
Serve as business technical approver for Quality for site deviations and CAPA.
Perform Annual Product Quality Report (APQR)
Review NPI-related documentation such as Master Batch Records (MBRs) and SOPs for accuracy and compliance
Review and approve process validation documentation (e.g., protocols, reports) to ensure compliance with regulatory requirements and client expectations
Oversee floor support, offering real-time Quality guidance and oversight to ensure compliance with procedures, regulatory requirements, and client expectations
Perform other duties as assigned to support site Quality and operational objectives

Education & Experience

Bachelor's degree in Biotechnology, Biology, Microbiology, Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related scientific discipline required.
Minimum 10 years of progressive experience in Quality Assurance, Quality Systems, Quality Operations, or related functions within a cGMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.