Strategic Quality Partner (d/f/m)

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The Position A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. Who we are

Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is every patient's right and every employee's responsibility. Our Chapter in Pre-Market Quality is accountable for providing quality support to Development Projects to ensure quality and filing readiness according to internal and external requirements.

The Opportunity

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 SQP, you will be responsible for ensuring effective partnerships with Development Project Teams, striving 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.

Key Responsibilities to drive business results and customer value:

• You will act as a single point of contact within the project team (New product development / Product Change) and lead strategic topics and decisions ensuring consistent interpretation & implementation of global requirements across Customer Areas.

• You will partner with Design Quality Partners (DQP) to decide efficient and effective documentation of milestone deliverables. Additionally, you will partner with internal and external stakeholders across the value chain to accelerate the development process and incorporate learnings.

• You will incorporate lessons learned from all areas of quality across Customer Areas into project support and ensure Postmarket Quality feedback is built into the requirements. To do this, you will develop and enhance playbooks to optimize/accelerate/enhance Pre Market Quality contributions for a given type of project/technology.

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

• You will drive awareness and adoption of the Risk Enabler inside and outside of Global Quality & Regulatory decision making. Your goal will be to prepare and enable risk-based decisions.

Key Responsibilities to advance the work of the organization:

• You will embed and continuously improve knowledge management within Pre Market Quality, fostering the effective sharing and retention of valuable knowledge and expertise.

• You will foster a culture of innovation and continuous improvement, nurturing a creative and problem-solving mindset throughout R&D, Product Development Quality, and other functions.

• You will serve as a role model and coach, supporting colleagues to grow and develop their skills, fostering a learning and development-oriented environment.

• You will reduce complexity and drive continuous improvement across customer areas with pragmatic solutions.

Who You Are

• You hold a Bachelor's degree in science, business administration, or a related field (MBA or advanced degree is considered an advantage) and bring with 8+ years of relevant work experience in the diagnostics industry or a related field in business-related functions.

• You are characterized by a strong business and financial acumen with an enterprise mindset.

• You bring a strong scientific and technical background with sound product knowledge (ideally with chemically and biologically based assay and reagent development experience in the molecular diagnostics environment). You are equipped with knowledge of Regulations pertaining to the environment (i.e. ISO 13485, GDP, GMP, others) as well as an E2E understanding for lifecycle management.

• You are well known for pragmatic decision-making and the ability to move forward without a perfect solution.

• You bring strong leadership capabilities, with experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change. You will seek to inspire and lead your global team to create transformative solutions and to influence their prioritization and uptake in the wider organization, in order to ensure that customer solutions are at the forefront of Pre Market Quality and deliver its optimal contribution to the Roche Diagnostics Vision.

Locations: Penzberg or Rotkreuz

As this position is part of a global organization, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities.

Your application

We make it easy! All you need to do is upload your CV in English. Further documents will be requested if required.

We look forward to receiving your application! Your contact to us! With people. For people.

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Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity.

Roche at Penzberg, near Munich, employs more than 7,000 people. The site is one of the largest biotechnology centers in Europe and the only Roche site with research, development, and production for both Pharmaceuticals and Diagnostics under one roof. From your beginning with Roche, our motivated team will welcome and support you. Numerous opportunities for personal development, flexible work hours, attractive compensation packages, and special family assistance programs are available.

Roche is an Equal Opportunity Employer.