Quality System Supervisor
About Animal Health Business
As the leading animal health company in China, we have extensive business coverage from the full value chain in R&D, production to sales and a diversified product portfolio covering swine, poultry, pets, cattle vaccines and medicines. We are always "in China and for China". We've pioneered many game-changers in the veterinary medicine, and we're looking to our customers' needs to guide us into the future.
Job Accountability:
-Quality Management System (QMS) Establishment and Maintenance for Shanghai site：
•Establish, maintain, and continuously improve the local Quality Management System (QMS) in alignment with Boehringer Ingelheim internal quality standards, applicable regulatory expectations, and local business needs.
• Develop and maintain quality documentation, including SOPs, templates, records, and Quality Management Review (QMR) documents, ensuring effective document lifecycle management (drafting, review, approval, distribution, archiving, and destruction).
• Develop the annual Quality Plan and ensure timely and effective execution of planned quality activities.
Manage deviations, CAPA, change control, and risk assessments, ensuring robust root cause analysis and timely closure.
-Quality Electronic System Management for GI China:
VQD System
• Manage and maintain the VQD system to ensure effective document control, traceability, and compliance with quality standards.
• Provide user support and coordinate system optimization, upgrades, and validation activities as required.
Learning Management System (LOS)
• Administer the LOS system, including curriculum setup, training assignment, and ongoing maintenance.
•Ensure training requirements are aligned with job responsibilities and QMS needs, achieving timely training completion.
•System Support and Continuous Improvement
•Provide user support for VQD and LOS systems and resolve routine system and operational issues.
•Collect and consolidate system optimization needs, and participate in system upgrades, validation activities, and related process improvements.
-Quality Documentation and Archive Management for Shanghai site：
• Manage daily operations of the Shanghai archive room, ensuring compliant storage, traceability, and retrievability of quality records, with no critical findings.
• Ensure controlled management of quality documents and records, including indexing, archiving, retention, and retrieval in accordance with internal requirements.
•Perform formal quality document reviews (format, version control, templates, signatures) for SOPs, protocols, experimental records, reports, and forms prior to release.
-Internal and External Audits and Quality Inspections for Shanghai site：
• Develop and execute internal audit plans covering early research laboratories and process development activities.
• Lead and support external audits and inspections, including preparation, onsite support, response to findings, and implementation of corrective actions.
• Conduct routine risk-based quality inspections focusing on data integrity, good documentation practices, training compliance, critical materials management, experimental records, etc.
• Track and resolve quality issues identified through audits and inspections to continuously reduce R&D quality risks.
-Quality Project Execution aligned with the global GI quality strategy：
• Take direct ownership of quality project execution at the Shanghai site, with hands-on responsibility for planning, implementation, and delivery.
• Lead China-wide quality initiatives and events, and actively drive cross-site collaboration, experience sharing, and best practice implementation.
Job Requirements:
-Minimum Education/Degree Requirements: Bachelor degree or above with major focus on Chemistry, Pharmaceuticical or Veterinary.
-Required Capabilities (Skills, Experience, Competencies)
•3-5 years or above working experiences in a pharmaceutical and vaccine regulatory environment.2-3 Working experiences in R&D quality systems, or laboratory quality management within pharmaceutical, biological, or related R&D environments.
•Experience with audits, inspections, and quality risk management is preferred.
•Fluent oral and written English.
•Good organizational skills; Cross-functional networking and influencing ability; Good communication and interpersonal skill is preferred.
•Strong problem solving capability including strategic and creative thinking. Ability to handle multiple priorities and deal with ambiguity.
•Utilize office software expertly, such as Words, PDF and PPT etc.