• Job Description

  Req#: R1256169

  For over 50 years, SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillary electrophoresis. Our products enable our customers to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.

  SCIEX is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

  Learn about the Danaher Business System which makes everything possible.

  As a Senior Manager, China QARA, you will be at the forefront of ensuring the highest standards of quality and regulatory compliance in our dynamic organization. In this pivotal role, you will lead our quality assurance and regulatory affairs team, navigating complex regulatory landscapes and setting new benchmarks in product excellence and safety. Your expertise will be instrumental in shaping strategies, driving continuous improvement, and maintaining compliance with global regulations. Join us to make a significant impact in our industry, leveraging your skills to foster innovation, ensure product integrity, and uphold our commitment to excellence. This is your opportunity to lead with vision in a role where your actions directly contribute to the success and integrity of our business.

  This position is part of the Quality Assurance and Regulatory Affairs department and will be located in Shanghai. Our vision is to create outstanding value for SCIEX through expertise in Quality Assurance and Regulatory Affairs.

  In this role, you will have the opportunity to do the following:

  • Local Representative for Global QARA Operations: Serve as the key point of contact and representative for the organization's global QARA initiatives within China. Ensure alignment of local strategies with global QARA objectives, fostering effective communication and coordination between regional and global teams.
  • Leadership and Team Development: Lead and develop the local QARA team, providing strategic direction, mentorship, and training. Ensure the team is well-equipped to handle the complexities of quality and regulatory requirements in the Chinese market.
  • Regulatory Compliance and Strategy: Stay updated with Chinese regulatory changes and interpret their implications for the business. Develop and implement strategies to ensure compliance with local regulations while aligning with global standards.
  • Quality Assurance Systems Management: Oversee the development and maintenance of robust quality assurance systems. Ensure these systems are in line with both local Chinese standards and international best practices, promoting consistency and excellence across all operations.
  • Audit and Risk Management: Conduct and oversee regular audits, both internal and external, to ensure adherence to quality and regulatory standards. Proactively identify and mitigate risks related to quality and regulatory compliance.
  • Cross-Functional Collaboration: Act as the QARA ambassador within the organization, fostering strong relationships with other departments such as R&D, manufacturing, and supply chain. Ensure that quality and regulatory considerations are integrated into all aspects of the business operations in China.
  • Reporting and Communication: Maintain accurate and comprehensive documentation and reports on quality and regulatory activities. Regularly communicate updates, challenges, and achievements to senior management, ensuring transparency and informed decision-making in the global context.

  The essential requirements of the job include:

  • Educational Background: Bachelor's degree or higher in a related field such as Life Sciences, Bioengineering, Quality Management, or Regulatory Affairs. Advanced degrees or certifications in quality assurance or regulatory affairs are highly preferred.
  • Professional Experience: At least 7-10 years of experience in quality assurance and regulatory affairs, with a proven track record in a managerial or leadership role, preferably within the relevant industry.
  • Regulatory Knowledge: In-depth knowledge of Chinese regulatory requirements and procedures, as well as familiarity with international regulatory standards (such as FDA, EMA). Experience in navigating the regulatory landscape for product approvals and compliance.
  • Quality Assurance Expertise: Strong background in developing and managing quality systems, conducting audits, and implementing quality improvement processes.
  • Communication and Language Skills: Excellent communication and interpersonal skills. Proficiency in both Mandarin and English is essential to liaise effectively with local authorities and global teams.
  • Leadership and Team Management: Demonstrated ability to lead and motivate a team, with strong skills in team building, mentorship, and performance management.
  • Analytical and Problem-Solving Abilities: Strong analytical skills with the ability to assess complex situations, identify key issues, and solve problems effectively. Ability to manage risks and make decisions that align with both local and global business objectives.

  It would be a plus if you also possess previous experience in:

  • Experience with Regulatory Authorities: Hands-on experience in liaising with Chinese regulatory authorities and a solid understanding of the processes for product registrations, licensing, and audits in China.
  • Project Management Skills: Demonstrated ability in managing complex projects, including cross-departmental initiatives, within strict timelines and budgets.
  • International Regulatory Exposure: Prior experience or exposure to international regulatory environments, providing an understanding of how to integrate global standards with local Chinese regulations.

  SCIEX, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

  At SCIEX we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for SCIEX can provide.

  When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
  
  At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
  
  If you’ve ever wondered what’s within you, there’s no better time to find out.

• About the company

  Danaher Corporation is an American globally diversified conglomerate with its headquarters in Washington, DC.

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