{"id":2418667,"url":"https://alion.io/job/lottebiologics-sr-manager-qa-program-lead","title":"Sr. Manager, QA Program Lead","company":{"id":4417994,"name":"Lotte Biologics","domain":"lottebiologics.com","url":"https://alion.io/company/lottebiologics","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"QA","role_family":"QA","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Syracuse, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":91000,"max":142000,"currency":"USD","period":"year","gross":null,"usd_annual":142000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-21T12:32:24Z","employer_posted_date":"2026-09-21","last_verified_at":"2026-10-14T12:17:12Z","board_verified":true,"closed_at":null,"days_open":23,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":23},"description":"We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World. \nA 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. \nPosition Summary\nThe 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.\nIn 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.\nDuties & Responsibilities\nLeads and provides management oversight to the QA Program Teams.\nRepresent Quality Assurance on New Product Introduction teams by directly interfacing with client, serving as decision maker and Quality SME\nAccountable for ensuring deviation investigations are based on sound scientific rational and appropriate actions are taken to prevent recurrence.\nEnsures that all QA Program Team personnel have adequate training, education and experience to perform their GMP related job function effectively.\nProvide quality oversight of start-up activities including approval of master and executed production batch records and associated process documentation.\nCommunicates complex information clearly and concisely demonstrating knowledge of quality and compliance\nCoordinate activities across the Quality organization to ensure success of new product introduction projects\nServe as main point of communication for established clients, providing necessary notifications on Quality related topics as required by the Quality Agreement\nGenerate, review and approve Quality Agreements with new clients, engaging in negotiations with client to determine key Quality interactions\nServe as contact for Client Quality PIP, escorting as needed and engaging, as necessary, during Quality visits from clients\nOversee and manage client- specific change control activities, including impact assessments, record and action approvals, and ensuring appropriate client involvement and approvals.\nServe as business technical approver for Quality for site deviations and CAPA.\nPerform Annual Product Quality Report (APQR)\nReview NPI-related documentation such as Master Batch Records (MBRs) and SOPs for accuracy and compliance\nReview and approve process validation documentation (e.g., protocols, reports) to ensure compliance with regulatory requirements and client expectations\nOversee floor support, offering real-time Quality guidance and oversight to ensure compliance with procedures, regulatory requirements, and client expectations\nPerform other duties as assigned to support site Quality and operational objectives\nEducation & Experience\nBachelor's degree in Biotechnology, Biology, Microbiology, Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related scientific discipline required.\nMinimum 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.\nExperience supporting client-facing quality activities, technical transfer, new product introduction (NPI), change control, deviations, CAPA, and Quality Agreements preferred.\nPrior leadership, people management, or cross-functional team leadership experience preferred.\nExperience serving as a primary Quality representative for external clients, regulatory inspections, audits, or commercial manufacturing programs.\nDemonstrated experience reviewing and approving deviations, CAPAs, change controls, and Quality Agreements in a cGMP-regulated environment.\nKnowledge, Skills, Abilities\nAbility to interact with external clients in clear and concise manner.\nAbility to interpret and apply phase appropriate cGMPs, compendia, regulatory requirements, and industry best practices in order to provide Quality guidance to project teams\nDemonstrated problem solving ability, attention to detail, and analytical thinking skills.\nAbility to take initiative, lead multiple projects simultaneously with minimal supervision, and adhere to scheduled timelines while maintaining flexibility.\nAbility to provide leadership, direct and influence others in a team based collaborative environment.\nAbility 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\nExcellent written and verbal communication skills\nAbility to maintain and promote a safe work environment\nPhysical Demands\nAbility to sit, stand, walk, bend, stoop, kneel, crouch, reach, and use hands and arms for routine office and manufacturing support activities.\nAbility to travel throughout office, laboratory, warehouse, and manufacturing areas on a frequent basis.\nAbility to wear required personal protective equipment (PPE) and applicable cleanroom gowning for extended periods when supporting operations in classified manufacturing environments.\nAbility to visually inspect documentation, manufacturing processes, equipment, and materials.\nAbility to communicate effectively in both office and production environments.\nWork Environment\nThis position operates in both office and manufacturing environments.\nRoutine presence in laboratory, warehouse, dispensary, and manufacturing areas is required to support quality oversight activities.\nRequired use of PPE, cleanroom gowning, and adherence to site safety and contamination control procedures when entering operational areas.\nExposure to manufacturing equipment, production operations, material handling activities, varying temperatures, and elevated noise levels may occur.\nInteraction with internal stakeholders, external clients, auditors, and regulatory representatives is a routine aspect of the role.\nSupervisory Responsibilities \nLeads 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.\nTravel\nThis role may require 10-25% travel. \nTarget Bonus\n16%\nWork Location:\nEast Syracuse, NY \nNew York Pay Range\n$91,000—$142,000 USD\n We are an Equal Employment Opportunity (“EEO”) Employer. \n 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!","description_format":"text","description_chars":8098,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-13T04:26:21Z"}],"visa":[],"liveness":{"score":70,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.773,"p_room":0.9,"age_days":22,"expected_fill_days":38,"reasons":["conf:3","win:mid"],"computed_at":"2026-10-14T06:34:16Z"},"pay":{"stated_usd_annual":142000,"is_top_pay":false},"html_url":"https://alion.io/job/lottebiologics-sr-manager-qa-program-lead","json_url":"https://alion.io/job/lottebiologics-sr-manager-qa-program-lead.json","meta":{"generated_at":"2026-10-14T14:17:40Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":17539,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-15T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":4417994},"rest":"https://alion.io/mcp/rest/get_company?id=4417994"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flottebiologics-sr-manager-qa-program-lead"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Flottebiologics-sr-manager-qa-program-lead"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Flottebiologics-sr-manager-qa-program-lead"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/lottebiologics-sr-manager-qa-program-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flottebiologics-sr-manager-qa-program-lead"}]}