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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.
Quality is a competitive advantage for Roche. It allows us to deliver highquality products to patients ensures our right to operate and helps us create value through process excellence and continual improvement efforts. Quality is every patients right and every employees responsibility.Our Chapter in PreMarket Quality is accountable for providing quality support to Development Projects to ensure quality and filing readiness according to internal and external requirements.
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 thriving for project acceleration and ensuring no delay in milestones and project . 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 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 youwill 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. T 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 problemsolving 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 developmentoriented environment.
You will reduce complexity and drive continuous improvement across customer areas with pragmatic solutions.
You are holding a Bachelors 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 with 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 with strong leadership capabilities with experience in leading crossfunctional 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
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.
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Full-Time