Quality Assurance Expert

在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。

职位

Objectives and Scope of Position:

● Strategy/Execution Ratio: You will operate with a balanced focus between strategy and execution (50% Strategy / 50% Execution), driving long-term goals and executing business processes.

● Design and deliver Quality Strategies and conclusions for assigned entities/processes.

● Contribute to the delivery of PDQ work and the development of PDQ processes.

● Lead and participate in PDQ goals and initiatives and support regulatory authority inspections.

● Apply a risk-based approach to Quality Assurance strategies based on the Critical to Quality (CtQ) framework.

● Mentor and support the development of Quality Leads within the team.

Summary of Main Responsibilities:

● Design and Implementation of Quality Strategies

○ Establish relationships with business stakeholders and lead the development of molecule/product/process/affiliate-level approaches with appropriate measures (CtQ Factors).

○ Analyze quality data to identify trends and risks, providing insights to business partners.

● Delivery of Activities to Assess Quality Status

○ Lead and perform complex audits and quality assessments.

○ Synthesize individual audit issues into systematic conclusions and present findings and associated risks to senior stakeholders, ensuring quality data fulfills regulatory requirements and supports organizational goals.

● Demonstration of Implementation to Health Authorities

○ Play a lead role in inspection preparation and management.

○ Provide training to staff and ensure relevant materials are prepared for regulatory review.

● Execution of PDQ Goals

○ Lead assigned goals and initiatives and drive the development or revision of PDQ processes.

Networking:

● Maintain and influence partnerships with senior business stakeholders and PDQ domains.

● Facilitate cross-functional collaboration to ensure quality standards are met globally.

Compliance:

● Expert knowledge in GxP regulations (NMPA, ICH guidance) and internal policies.

● Ensure all activities are conducted in compliance with regulatory and company requirements.

Qualification, knowledge and experience:

Minimum Qualification:

● Bachelor’s degree or equivalent in a scientific or quality-related field. Advanced degree preferred.

Minimum Experience / Knowledge:

● Significant experience in the pharmaceutical / biotech / medical device industry, including knowledge of the end to end development and operationalisation of products, and the associated GxP regulations and considerations (e.g., GCP, IVD/MD Regulations).

● Bachelor’s degree or equivalent in a scientific or quality-related field or equivalent combination of education, training, and experience.

● Advanced degree in referenced fields preferred.

● Extensive experience in leading GxP audits and managing complex quality projects.

● In-depth knowledge of drug development processes and global regulatory landscapes.

● Good understanding of Information Systems, e.g., audit management and analysis reporting tools.

● Understanding of business operations and strategies.

● Fluency in written and spoken English; bi or multi-lingual skills are desirable.

Personal competencies:

● Strong digital and data literacy

● Skilled in using and analyzing data to drive solutions.

● Advanced communication and presentation skills.

● Strong stakeholder management and engagement skills.

● Comfortable working with ambiguous and complex information and able to synthesize it into clear and concise points of view to influence decision-making and action-taking.

● Ability to influence with and without authority, and negotiate effective solutions.

● Proven critical thinking, analytical, problem-solving, and decision-making skills.

● Ability to work effectively in an international, multicultural matrix organization and as part of agile project teams. Demonstrates effective teamwork and collaboration skills.

● Agile and creative in designing analytical solutions.

● Experienced in leading global project teams, and strong project management skills.

● Strong organizational and execution skills, and demonstrated ability to work independently and proactively.

● Proven leadership and mentoring abilities.

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

罗氏提供平等的职业发展机会。