Senior Specialist, QA Program Management
LOTTE BIOLOGICS USA, LLCEast Syracuse, New York, United States · Posted 18 days agoDescription
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. Specialist, QA Program Management is responsible for executing and supporting client-related Quality Assurance activities within a CDMO environment, providing quality oversight to internal stakeholders during new product introductions, technical transfers, and lifecycle management for existing products. This role supports client programs by ensuring internal alignment with site procedures, client requirements and Quality Agreements by applying specialized knowledge of cGMP regulations.
The role executes assigned QA deliverables, including document review and approval, and provides on-the-floor manufacturing Quality oversight to ensure compliant and efficient operations. This role is responsible for the execution and QA oversight of deviations, ensuring timely investigation, documentation, and closure, as well as supporting and overseeing client-specific change control activities, including recommendation, review, and approval of actions. The Sr. Specialist also supports implementation of client requirements through internal processes and contributes to broader site Quality and operational initiatives as needed. This role requires the application of scientific and quality principles to interpret established standards, assess documentation and quality information, and support compliant decision-making in a cGMP-regulated environment.
Duties & Responsibilities
- Execute assigned QA activities for the Quality organization to enable successful new product introductions (NPI) and technical transfer projects, and lifecycle management activities in accordance with cGMP requirements, site procedures, client requirements, and Quality Agreements.
- Review assigned activities and documentation for alignment with Quality Agreements, site procedures, and client requirements; identify gaps and recommend required actions, escalation, or client notification for appropriate Quality review.
- Issuance of Quality-related Client Notifications and escalations through appropriate channels
- Draft, review, and maintain Quality Agreements by gathering inputs, identifying gaps, tracking deliverables, and routing agreements for appropriate review and approval for new and existing clients in alignment with internal processes and regulatory requirements.
- Participate in inspection and audit readiness activities by audit team participation as needed, reviewing assigned records, identifying potential compliance gaps, and recommending corrective actions for review. Serve as a QA representative during audits and inspections as assigned, providing factual information and supporting responses in coordination with senior Quality personnel.
- Drive execution of client-specific change control activities, including impact assessments, record review, and action tracking, in alignment with internal procedures.
- Perform QA review of site deviations and CAPAs, supporting thorough investigation, root cause analysis, and timely closure.
- Support preparation of Annual Product Quality Reviews (APQRs) to ensure ongoing process consistency and compliance.
- Review assigned NPI-related documentation such as Master Batch Records (MBRs) SOPs, BOMs, protocols, reports, and SOPs, for completeness, accuracy, and alignment with established requirements; identify issues and recommend revisions.
- Review process validation documentation (e.g., protocols and reports) to support compliance with regulatory and client requirements.
- Provide manufacturing Quality oversight, advising manufacturing operations to ensure adherence to GMP, procedures, and operational standards.
- Collaborate with cross-functional teams to communicate QA expectations, clarify procedural requirements, support timely completion of assigned deliverables.
- Perform other duties as assigned to support site Quality systems and operational objectives.
Education & Experience
- Bachelor's degree in Biotechnology, Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related discipline required.
- Minimum of 2-4 years of experience in a cGMP-regulated pharmaceutical, biotechnology, medical device, or CDMO environment, with experience in Quality Assurance, Quality Systems, Manufacturing Quality, Program Management, or related functions.
- Experience supporting quality systems and compliance activities is preferred, which may include: deviations, CAPAs, change controls, investigations, document management, validation, technical transfers, and new product introductions (NPI).
- Hands-on experience with an electronic Quality Management System (eQMS) is strongly preferred. Experience with Veeva Vault Quality/QualityOne is highly desirable; equivalent systems such as TrackWise, MasterControl, ETQ, or similar platforms will also be considered.
- Experience interacting with clients, regulatory agencies, and cross-functional stakeholders in a GMP-regulated environment preferred.
Knowledge, Skills, Abilities
- Ability to interpret and apply phase-appropriate cGMPs, regulatory requirements, and industry best practices to support execution of Quality Assurance activities.
- Problem-solving skills, attention to detail, and analytical thinking, with the ability to identify issues and support effective resolution.
- Ability to manage multiple assigned tasks and priorities simultaneously, demonstrating initiative while working independently within established timelines.
- Ability to collaborate cross-functionally and contribute to team-based decision-making in a matrixed environment.
- Ability to analyze and interpret data, apply risk-based quality principles, and support sound, compliant decision-making.
- Strong written and verbal communication skills, with the ability to clearly document and convey Quality-related information internally.
- Commitment to maintaining and promoting a safe and compliant work environment.
Physical Demands
Primarily an office-based and floor oversight position requiring sitting, standing, bending/stooping, twisting, crouching/squatting, kneeling, sitting, walking (level surfaces), reaching (shoulder), repetitive use of arm, hands, wrists, and accurate vision (acuity, color – correction allowed). This position will also routinely enter the laboratory, warehouse, dispensary and manufacturing floor environments, requiring appropriate levels of PPE and/or special gowning requirements.
Work Environment
Primarily an office-based and floor oversight position. This position will also routinely enter the laboratory, warehouse, dispensary and manufacturing floor environments, requiring appropriate levels of PPE and/or special gowning requirements.
Travel
Less than 5% of travel is required for this position.
Target Bonus
8%
Work Location:
East Syracuse, NY
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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