Strategic Quality Partner

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

We are seeking a highly motivated Strategic Quality Partner (SQP) to join our Product Development Quality organization, reporting to the Subchapter lead Product Development Quality. As the Strategic Quality Partner, you will be responsible for ensuring effective partnerships with Development Project Teams, thriving for project acceleration and  ensuring no delay in milestones and project execution. You drive consistent interpretation & implementation of global requirements across Customer Areas (CAs). You ensure the deployment and implementation of the D&D module and drive awareness and adoption of the Risk Enabler inside and outside of Global Q&R decision making. You are an example of living collective success by working, trusting and empowering each other.  

The Opportunity 

•  You act as a single point of contact within project teams (New Product Development / Product Change) and partner with Design Quality Partners (DQP) to decide efficient and effective documentation of milestone deliverables.  You are skilled in leading strategic topics and decisions. You facilitate constructive discussions e.g. at project team meetings.

• You partner with internal and external stakeholders across the value chain to incorporate learnings in the development process. You ensure effective feedback loops and information flow for milestone review. This includes developing and enhancing playbooks to optimize/accelerate/enhance Pre Market Quality contributions for a given type of project/technology.

• You ensure consistent interpretation & implementation of global requirements across Customer Areas (CAs) and incorporate lessons learned from all areas of quality across Customer Areas (CA) into project support and ensure Postmarket Quality feedback is built into the requirements.

• You ensure development project plans contain the right deliverables according to D&D module to deliver safe and compliant solutions.

• You support internal and external audits and partner to ensure effective resolution of issues (e.g. CAPA, NC).

• You drive awareness and adoption of the Risk Enabler inside and outside of Global Q&R decision making; prepare and enable risk based decisions.

•  You advance the work of the organization by continuously improving knowledge management within Pre Market Quality, fostering the effective sharing and retention of valuable knowledge and expertise.

• You ensure effective change management in Product Development Quality, R&D and other functions, while fostering a culture of innovation and continuous improvement, nurturing a creative and problem-solving mindset throughout R&D, Product Development Quality and other functions.  

Who You Are

•  You have a Bachelor's degree in science, business administration or a related field. MBA or advanced degree is considered an advantage.

• You have + 8 years of experience in the diagnostics industry or a related field in business related functions.

• You have strong business and financial acumen with an enterprise mindset with scientific and technical background with sound product knowledge, ideally with system/hardware/software development experience related to sequencing technology. 

• You have knowledge of Regulations pertaining to the environment  (i.e. ISO 13485, GDP, GMP, others) and demonstrated thorough E2E understanding for lifecycle management.

Leadership

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