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Head Of R&D Quality-Animal Health Global Innovation

5-10 years
Not Disclosed
10 Dec. 6, 2024
Job Description
Job Type: Full Time Education: PhD/MD/MBA/MSc/Bsc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.