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:
- 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.
- 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 Pharmaceuticical, Biopharma, Veterinary or similar expertise.
- 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.
- 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.
