Strategic Quality Partner - R&D Quality

Roche

  • 江苏省苏州市
  • 长期
  • 全职
  • 22天前
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionAs the PDQ (Product Development Quality) Strategic Quality Partner, act as a single point of contact for new product development, product changes and technical transfer project. Partner with team members to streamline documentation and lead strategic topics and decisions. Collaborate with both internal and external stakeholders to expedite development and incorporate lessons learned from post-market quality. Ensure all necessary deliverables are delivered to produce safe and compliant products.Skilled at driving risk-based decisions, facilitating team discussions, and partnering to resolve issues like NC/CAPAs and Design Changes.Main Tasks & Responsibilities :Has deep and/or broad expertise in his/her area of specialization and has good knowledge of the overarching areas of responsibility.
  • Knowledge of the relevant regulations (e.g. ISO 13485, GMP, others)
  • Proven in-depth understanding of the end-to-end processes in product lifecycle management
Develops new approaches to complex problems. Can persuade and guide others to solve the problem.
  • Pragmatic decision making and the ability to move forward without a perfect solution
  • Excellent communication, presentation and negotiation skills.
  • Ensure effective change management in Product Development Quality Chapter, R&D and other functions
  • Support timely and data and fact-based decision-making and implementation
Shares experience and serves as a source of information for others.
  • Implement and continuously improve knowledge management within Pre-Market Quality, promote effective sharing and retention of valuable knowledge and expertise.
  • Foster a culture of innovation and continuous improvement that supports a creative and problem-solving mindset across R&D, Product Development Quality and other functions
  • Act as a role model by demonstrating behaviors that support the transition to a new model of work with a focus on agility, collaboration and adaptability
  • Support colleagues as a coach in developing their skills and fostering a learning and development-oriented environment
Ensures the creation and evolution of a quality concept for the assigned strategically important product group that builds on each other, meets requirements and is cost-conscious.
  • Function as single point of contact within the project team (development of new products / product changes/product transfer)
  • Collaborate with team members to ensure efficient and effective documentation of milestones
  • Ensure development project plans include the correct documentation as per the D&D module to develop safe and compliant products
Responsible for the efficient implementation of relevant local and international laws, standards and regulations.
  • Ensure consistent interpretation and implementation of global requirements across all customer areas (CAs), especially China requirements
  • Promote the use of the Risk Enabler within and outside the global Q&R organization; prepare and enable risk-based decisions
  • Partner to ensure effective resolution of issues (e.g. CAPA, NC)
Lead complex and cross-functional projects.
  • Collaborate with internal and external stakeholders across the value chain to accelerate the development process and incorporate lessons learned.
  • Incorporate learnings from all quality areas across all customer areas (CA) in support of projects and ensure that post-market quality feedback is incorporated into requirements
  • Leading and moderating constructive discussions, e.g. at project team meetings
  • Ensuring the exchange of information for milestone reviews and setting up effective feedback loops
Additional Quality relevant responsibilities.
  • Support internal and external audits
  • Other tasks assigned by line manager.
Qualification & Experience:
  • A Bachelor’s degree in Life Science, pharmaceutical engineering or related subject. Advanced degree is considered an advantage.
  • Competent with routine application of MS Office
  • At least ten (10) years in the Medical Device/IVD/Pharma/Biopharmaceutical industry
  • Has worked in more than one function within quality management and may have worked outside of Quality Management, e.g. R&D. Can managing highly complex and/or global projects, or equivalent experience.
  • Familiar with the common processes in development as well as general business practices within the regulated field of diagnostics and/or medical device.
  • Knowledge of the European, US, China and International cGMP regulations
Have practical experience in ISO13485/CGMP and/or other regulatory system experience in quality auditing * Good in communication and report writing in Chinese and EnglishLeadership Competencies:Leadership competencies at proficient level, in line with corporate framework.Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let’s build a healthier future, together.Roche is an Equal Opportunity Employer.

Roche