Job Title: Quality Strategy & Assurance Lead - Animal Health Business
Job ID: 18092
Location: China
About Boehringer Ingelheim - Animal Health Business
As a leading animal health company in China, Boehringer Ingelheim covers the full value chain from R&D to sales, with a diverse product portfolio including vaccines and medicines for swine, poultry, pets, and cattle. We have pioneered game-changing veterinary medicine and continue to focus on customer-driven innovations.
Job Responsibilities
1. Quality Strategy Roadmap
Drive the overall quality strategy for GI Quality China, focusing on quality projects, new product development, and technology transfers.
Align with global innovation and supply chain needs, ensuring consistency with global quality strategies.
Serve as the primary interface with Regulatory Affairs and regulatory agencies.
Participate as a member of the local site leadership team.
2. Quality Assurance in CMC (Chemistry, Manufacturing, and Controls)
Lead a function to ensure quality and compliance during the transfer of analytical and technical processes.
Provide technical and regulatory expertise for production and analytical transfers.
Ensure the quality of all Chemistry, Manufacturing, and Controls processes and products.
3. Supervise Quality Management System (QMS)
Represent the quality function in respective subteams and report on QA work packages.
Monitor and escalate any QC/QA issues to ensure smooth operations.
4. Audits & Inspections
Prepare for and accompany internal and external audits, as well as inspections by regulatory authorities.
Conduct supplier audits to ensure the quality of raw materials and services.
Collaborate with Global Supply Chain Quality to align with global QA strategies and regulatory requirements.
5. Leadership to Global Innovation QA and Global Innovation
Support the leadership team (Regional Quality Head, Global Clinical, and Global Development) in defining strategic goals.
Lead a functional platform that ensures smooth QA teamwork, network building, and priority setting.
Manage people development through performance reviews, talent development, and career mapping.
Develop and conduct GMP and CMC quality training programs for employees.
Drive continuous improvement efforts using advanced data management and quality methods/tools.
Job Requirements
Education & Experience
Doctoral Degree (e.g., PhD, MD) or Master’s Degree (e.g., MBA, MSc) or Bachelor’s Degree in Biotechnology, Microbiology, or related fields.
5-10 years of professional experience in vaccine research and development.
Profound knowledge of manufacturing processes, sterile and aseptic techniques.
Experience in biopharmaceutical processes such as upstream, downstream formulation, and analytical methods is preferred.
Preferably experience in a pharmaceutical company working under GMP regulations.
Knowledge of China’s regulatory requirements (CVP) is essential.
Skills & Competencies
Experience in functional leadership and working in a multicultural environment.
Ability to implement strategic goals and work in a matrix organization.
Strong project management, leadership, and communication skills.
Proficiency in both English and Chinese (fluent in reading, writing, and speaking).
Experience in regulatory inspections and GxP requirements.
Strong decision-making skills with the ability to balance risks and consequences.
Proactive and driven to make significant improvements.
Why Boehringer Ingelheim?
Growth and Development: We offer challenging work with opportunities for personal growth, development, and a career path tailored to your aspirations.
Global Collaboration: Work in a diverse and inclusive environment, collaborating across cultures and global teams.
Impactful Work: Your role will directly contribute to improving the lives of animals and humans through innovative health solutions.
Commitment to People: We are an equal opportunity global employer who values diversity and inclusivity.
For more information, visit Boehringer Ingelheim Careers.
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