Strategic Quality Partner Product Development Quality

Company: F. Hoffmann-La Roche Gruppe
Location: Carlsbad
Posted on: September 1, 2024

Job Description:

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 PositionAt 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.
  • 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
    • You are a pragmatic decision maker with the ability to move forward without a perfect solution.
    • You are an excellent communicator with strong presentation, and negotiation skills. You have an agile mindset and demonstrate new ways of working.
    • You have experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change.
    • You inspire the organization to think in terms of impact and outcomes rather than tasks and serve as a role model, exhibiting behaviors that support the transition to a new operating model emphasizing agility, collaboration, and adaptability.LocationsYou are located in Carlsbad, California. Relocation benefits are available for this position.The expected salary range for this position based on the primary location of Carlsbad is $108,800 and $230,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.Who we areGenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark's ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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Keywords: F. Hoffmann-La Roche Gruppe, Carlsbad , Strategic Quality Partner Product Development Quality, Other , Carlsbad, California