Associate QC Manager
About Boehringer Ingelheim
Boehringer Ingelheim is committed to researching breakthrough therapies that transform lives today and for generations to come. As a research-driven, leading global biopharmaceutical company, Boehringer Ingelheim creates value through innovation in areas of high unmet medical need. Founded in 1885, the company remains independent and family-owned, with a long-term perspective. Across Human Pharma, Animal Health and Biopharmaceutical Contract Manufacturing, more than 53,000 employees serve over 130 countries and regions.
About Nanchang Site
Founded in 1990, the Boehringer Ingelheim Nanchang Animal Health manufacturing site is a poultry biological vaccine production site in China, producing GMP-compliant biological vaccine products. By the end of 2020, total site investment reached EUR 90 million and annual capacity reached 20 billion doses, serving the Chinese poultry biological vaccine market and other Asian countries. The Nanchang site will also continue expanding VAXXITEK® vaccine supply to more than 30 countries outside China, upgrading from “In China, for China” to “In China, for the World”.
Position Purpose:
To take accountability for the daily operation, technical capability and compliance performance of the Virus Team, ensure QC testing, investigations, assay transfer, validation and documentation are delivered on time, scientifically justified, fully traceable and inspection-ready under GMP, internal standards and applicable regulatory expectations.
Job Responsibilities:
-Be responsible for Virus Team priorities and execution discipline: convert quality and business needs into accountable action plans, assign clear owners and timelines, coach team members, and drive follow-up until issues, risks and decisions are closed with documented outcomes.
-Lead or actively drive QC and cross-functional initiatives with QA, Manufacturing, MSAT, Engineering, EHS, Supply Chain and other stakeholders to remove barriers, resolve recurring issues, improve laboratory efficiency and reinforce quality ownership.
-Plan, schedule, coordinate and approve Virus Team testing in a timely manner, balance workload and resources, and ensure testing delivery supports production, release and business continuity requirements.
-Provide technical guidance and structured training to laboratory staff; identify performance and compliance gaps, implement SOP, GMP and technical-skill training, and verify effectiveness through follow-up actions.
-Lead OOS/OOT and deviation investigations in the Virus Team, define scientifically sound root causes and actions, review and approve related CAPA and changes, and ensure timely implementation, closure and effectiveness.
-Train and supervise technicians in daily testing execution, continuously evaluate virus-related test methods, and drive method optimization to ensure assays are performed in a robust, consistent and efficient manner.
-Lead assay transfer from other Boehringer Ingelheim sites or R&D units by owning transfer planning, technical assessment, protocol/report preparation, execution tracking, gap resolution and readiness for routine implementation.
-Be responsible for validation management for virus-related methods and equipment, provide timely technical decisions and guidance, and ensure validation deliverables are risk-based, scientifically justified, properly documented and completed as planned; prepare, review and approve virus-testing SOPs, test records, technical reports and related documents, and maintain a clean, safe and EHS-compliant workplace with Zero LTI.
Job Requirements
-Bachelor’s degree or above in Veterinary Medicine, Biochemistry, Virology, Microbiology, Biotechnology, Pharmacy, or a related discipline.
-Minimum 5 years of relevant team management experience within a manufacturing quality environment. Solid knowledge of GMP requirements and quality systems is required. Prior experience in QC, QA, or laboratory operations management will be considered an advantage.
-Ability to lead technical problem solving, support bio-assay method development or optimization, and collaborate with process teams to provide testing-related solutions for vaccine manufacturing process improvement.
-Familiarity with analytical method transfer, method validation, and related laboratory techniques. Knowledge of EU regulatory requirements, European Pharmacopoeia (Ph. Eur.), 9 CFR, or other relevant international regulatory and pharmacopoeia standards is preferred.
-Excellent communication, analytical, and problem-solving skills, with the ability to build effective partnerships across teams and functions. Demonstrates a strong continuous improvement mindset, eagerness to learn, and fluency in both written and spoken English.