Senior Manager, Animal Welfare & Integrity Assurance

Key Responsibilities:

1. Regulatory Expertise & External Environment

• Act as the recognized expert on animal research regulations, enforcement trends, and operating environment in China.
• Translate regulatory and industry developments into actionable guidance for internal stakeholders.
• Advise teams on regulatory feasibility, risk, and mitigation strategies for outsourced studies.

2. Outsourced Study Oversight & CRO Management

• Lead veterinary and animal welfare audit programs for contract research organizations (CROs) and external partners in China, including audit planning, execution, findings closure, and continuous improvement.
• Assess third-party capabilities (e.g., veterinary care, facilities, governance, training) against Novartis and international standards.
• Provide recommendations on site approval, risk mitigation, or alternative approaches.
• Oversee corrective and preventive actions (CAPAs) and in-life monitoring to ensure compliance and animal welfare standards are met.

3. Animal Welfare Advancement

• Promote the implementation of the 3Rs (Replacement, Reduction, Refinement) and support adoption of New Approach Methodologies (NAMs).  
• Identify opportunities to improve animal welfare, scientific quality, and operational consistency.

4. Stakeholder Engagement & Influence

• Serve as the primary point of contact for animal welfare and veterinary matters related to outsourced research in China.  
• Partner cross-functionally with scientific, procurement, QA, and governance teams to ensure consistent oversight and escalation.
• Communicate complex regulatory, scientific, and ethical topics to diverse audiences and influence decision-making across organizational boundaries.

5. Strategic & Operational Contribution

• Contribute to strategic initiatives, projects, and external collaborations involving animal research in China.
• Drive operational excellence and continuous improvement in outsourced research oversight.
• Represent Animal Welfare & Integrity Assurance at the Shanghai site and contribute to global AWIA initiatives and governance.

Essential Requirements:

• Doctor of Veterinary Medicine (DVM) or equivalent required; advanced degree preferred.
• Minimum 5 years of experience in preclinical research and laboratory animal medicine.
• Experience working across multiple species (e.g., rodents, rabbits, pigs, dogs, non-human primates).
• Experience in AAALAC-accredited environments and IACUC or equivalent ethical review processes.
• Experience overseeing outsourced studies and CROs, ideally within China or similar regulatory environments.
• Strong analytical, problem-solving, and project management skills.
• Excellent communication skills with the ability to influence senior stakeholders.
• Fluency in English and Mandarin (written and spoken).