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About the Role

The Sr. Manager QA Program Lead provides Quality Assurance technical expertise and guidance for new product introduction, technical transfer, and established customer activities. This role serves as the main Quality contact for clients, negotiating Quality Agreements, overseeing client-specific change controls, and approving site deviations to ensure compliant and efficient operations.

Responsibilities

Leads and provides management oversight to the QA Program Teams.
Represents Quality Assurance on New Product Introduction teams, interfacing with clients as a decision-maker and Quality SME.
Ensures deviation investigations are based on sound scientific rationale and appropriate actions are taken to prevent recurrence.
Ensures QA Program Team personnel have adequate training, education, and experience for GMP job functions.
Provides 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.
Coordinates activities across the Quality organization to ensure success of new product introduction projects.
Serves as the main point of communication for established clients, providing necessary notifications on Quality-related topics as required by the Quality Agreement.
Generates, reviews, and approves Quality Agreements with new clients, engaging in negotiations with clients to determine key Quality interactions.
Serves as contact for Client Quality PIP, escorting as needed and engaging during Quality visits from clients.
Oversees and manages client-specific change control activities, including impact assessments, record and action approvals, and ensuring appropriate client involvement and approvals.
Serves as business technical approver for Quality for site deviations and CAPA.
Performs Annual Product Quality Report (APQR).
Reviews NPI-related documentation such as Master Batch Records (MBRs) and SOPs for accuracy and compliance.
Reviews and approves process validation documentation (e.g., protocols, reports) to ensure compliance with regulatory requirements and client expectations.
Oversees floor support, offering real-time Quality guidance and oversight to ensure compliance with procedures, regulatory requirements, and client expectations.
Performs other duties as assigned to support site Quality and operational objectives.
Leads and facilitates cross-functional QA POD activities, providing direction, prioritization, and oversight.
Oversees the review and resolution of manufacturing, quality, and 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.

Requirements

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.
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.
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.
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.
10-25% travel may be required.

Skills

Quality Assurance
Quality Systems
Quality Operations
cGMP
Technical Transfer
New Product Introduction (NPI)
Change Control
Deviations
CAPA
Quality Agreements
Client-facing activities
Leadership
People Management
Cross-functional Team Leadership
Regulatory Inspections
Audits
Commercial Manufacturing
Problem Solving
Attention to Detail
Analytical Thinking
Risk-based Quality Principles
Written Communication
Verbal Communication

Location

East Syracuse, NY

Work Type

Onsite
Office
Manufacturing environments

Experience Level

Sr. Manager
10+ years experience

Education Level

Bachelor's degree in Biotechnology, Biology, Microbiology, Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related scientific discipline

Salary/Compensations

$91,000—$142,000 USD

Benefits

16% Target Bonus

About the Company

LOTTE BIOLOGICS is 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.

Equal Opportunity

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!