Director, Quality Assurance and Regulatory Affairs(GCP, Clinical Research Digital Solution)-Evinova China

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  • 上海

At Evinova, we put patients first and strive to meet their unmet needs worldwide.  Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality.  If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. 

Evinova is a health-tech business, separate company within the AstraZeneca Group, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside.  Through our application of science-based expertise, evidence-led rigor, and human experience-driven insight, our digital solutions are deliberately crafted so that everyone can reach better health outcomes together. 

This individual will work closely with the Head of Quality, Compliance, and Audit and the GM of China to ensure that operational activities align with our global strategy and local market needs. The ideal candidate will have a strong background in business strategy, operations, financial planning, and investor relations, with a proven ability to thrive in fast-paced, high-growth environments. 

The Director of Quality Assurance and Regulatory Affairs (QARA) will lead the regulatory affairs, quality assurance, and audit processes for our business in China. You will aid in the management customer audits, software qualification and regulatory compliance locally in China. This is a pivotal role that ensures our product meets local regulatory standards and supports our continued growth in China market. The ideal candidate will have robust experience navigating China’s regulatory landscape while collaborating with global teams to maintain a consistent standard of excellence. 

Key Responsibilities: 

  • Oversee and drive the qualification of platform and software products for China market. 

  • Ensure all software and digital solutions adhere to both Chinese and international regulations and standards. 

  • Collaborate with global and local teams to align regulatory strategies and documentation. 

  • Develop, implement, and continuously improve quality assurance processes tailored for the digital clinical research environment under the direction of the Head of Quality, Compliance, & Audit. 

  • Establish regulatory strategies to support product releases, ensuring full compliance with local and global standards. 

  • Manage and monitor the execution of quality control protocols across all stages of product development and deployment. 

  • Liaise with China regulatory authorities, certification bodies, and other partners to ensure timely and successful product approvals. 

  • Partner with Legal  support data privacy compliance and run Cross-Border Data Transfer (CBDT) initiatives in alignment with China regulations. 

  • Stay updated on regulatory changes and ensure the organization adapts to new compliance requirements effectively. 

  • Develop and implement a comprehensive audit program for China fitting into the Global QA Plan to proactively identify and mitigate risks.  

  • Act as a subject matter expert on quality assurance and regulatory affairs, advising internal customers on best practices specific to the China market. 

  • Work closely with global teams, local technical experts, product managers, and legal advisors to harmonize regulatory and quality initiatives. 

  • Provide regular reports, dashboards, and updates to the GM of China and the Global Head of Quality, Compliance, and Audit on compliance status, audit outcomes, and certification progress. 

  • Collaborate with cross-functional teams to integrate QARA standard methodologies into broader business operations. 

  • Continuously evaluate and improve quality assurance processes to meet evolving regulatory requirements and business needs. 

  • Champion industry best practices in quality assurance and regulatory affairs, encouraging a culture of excellence and innovation. 

Required Experience/Qualifications: 

  • Bachelor’s degree in Life Sciences, Engineering, Quality Management, Regulatory Affairs, or a related field; advanced degree (Master’s/PhD) is preferred. 

  • 8+ years of experience in quality assurance and regulatory affairs in the pharmaceutical or CRO industry, with robust understanding of Drug Development Processes and Clincal Trials.  

  • Proven expertise and success in managing regulatory compliance, quality assurance processes, and audit programs in China. 

  • In-depth knowledge of China regulatory requirements, including ICP filing, MLPS certification, data privacy, CBDT, PIPL, etc regulations. 

  • In-depth knowledge of the China pharmaceutical R&D market, particularly in clinical research and GCP practice. 

  • Previous audit experience in life science industry. 

  • Confirmed ability to work effectively in a global, matrixed environment, collaborating with cross-border teams and customers. 

  • Strong leadership, project management, and communication skills, with the ability to drive critical initiatives and encourage cross-functional teams. 

  • Proven track record to lead complex projects in a fast-paced, high-growth environment. 

  • Meticulous with strong analytical and troubleshooting skills. 

  • Fluent English and Mandarin, both can be used as working language

Why Evinova (AstraZeneca)? 

Evinova draws on AstraZeneca’s deep experience developing novel therapeutics, informed by insights from thousands of patients and clinical researchers. Together, we can accelerate the delivery of life-changing medicines, improve the design and delivery of clinical trials for better patient experiences and outcomes, and think more holistically about patient care before, during, and after treatment.  We know that regulators, healthcare professionals, and care teams at clinical trial sites do not want a fragmented approach. They do not want a future where every pharmaceutical company provides its own, different digital solutions. They want solutions that work across the sector, simplify their workload, and benefit patients broadly. By bringing our solutions to the wider healthcare community, we can help build more unified approaches to how we all develop and deploy digital technologies, better serving our teams, physicians, and ultimately patients.  Evinova represents a unique opportunity to deliver meaningful outcomes with digital and AI to serve the wider healthcare community and create new standards for the sector.  Join us on our journey of building a new kind of health tech business to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting-edge methods, and bringing unexpected teams together.

Location: Shanghai China

Salary: Competitive + Excellent Benefits!

So, what’s next? 

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you! 

Where can I find out more? 

Our Social Media, Follow Evinova on LinkedIn https://www.linkedin.com/company/evinova/  

Learn more about Evinova www.evinova.com