Sr. Manager, QA Program Lead

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.
Experience supporting client-facing quality activities, technical transfer, new product introduction (NPI), change control, deviations, CAPA, and Quality Agreements preferred.
Prior leadership, people management, or cross-functional team leadership experience preferred.
Experience serving as a primary Quality representative for external clients, regulatory inspections, audits, or commercial manufacturing programs.
Demonstrated experience reviewing and approving deviations, CAPAs, change controls, and Quality Agreements in a cGMP-regulated environment.
Knowledge, Skills, Abilities

Ability to interact with external clients in clear and concise manner.
Ability to interpret and apply phase appropriate cGMPs, compendia, regulatory requirements, and industry best practices in order to provide Quality guidance to project teams
Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
Ability to take initiative, lead multiple projects simultaneously with minimal supervision, and adhere to scheduled timelines while maintaining flexibility.
Ability to provide leadership, direct and influence others in a team based collaborative environment.
Ability to analyze and interpret data, draw appropriate conclusions, apply risk-based quality principles, and identify next steps in alignment with regulatory compendial and regulatory guidance
Excellent written and verbal communication skills
Ability to maintain and promote a safe work environment
Physical Demands

Ability to sit, stand, walk, bend, stoop, kneel, crouch, reach, and use hands and arms for routine office and manufacturing support activities.
Ability to travel throughout office, laboratory, warehouse, and manufacturing areas on a frequent basis.
Ability to wear required personal protective equipment (PPE) and applicable cleanroom gowning for extended periods when supporting operations in classified manufacturing environments.
Ability to visually inspect documentation, manufacturing processes, equipment, and materials.
Ability to communicate effectively in both office and production environments.
This position operates in both office and manufacturing environments.
Routine presence in laboratory, warehouse, dispensary, and manufacturing areas is required to support quality oversight activities.
Required use of PPE, cleanroom gowning, and adherence to site safety and contamination control procedures when entering operational areas.
Exposure to manufacturing equipment, production operations, material handling activities, varying temperatures, and elevated noise levels may occur.
Interaction with internal stakeholders, external clients, auditors, and regulatory representatives is a routine aspect of the role.
Supervisory Responsibilities

Leads and facilitates cross-functional QA POD activities, providing direction, prioritization, and oversight to ensure alignment with manufacturing, quality, safety, and business objectives. Oversees the review and resolution of manufacturing, quality, an deviations, ensuring timely investigations, effective root cause analysis, and implementation of sustainable corrective and preventive actions. Collaborates with cross-functional areas including, Manufacturing, Facilities & Engineering, and other stakeholders. Ensures QA actions, compliance commitments, and operational priorities are executed effectively, fostering a culture of accountability, operational excellence, and inspection readiness.
Travel

This role may require 10-25% travel.
16%
Work Location:

New York Pay Range
$91,000 - $142,000 USD
We are an Equal Employment Opportunity ("EEO") Employer.
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!

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