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The Strategic Quality Partner acts as a single point of contact within project teams (New product development / Product Change) for a portfolio of products assigned to them. The SQP leads and drives for decisions for strategic topics from a compliance and product quality perspective. The SQP partners with internal and external stakeholders across the value chain to accelerate the development process and incorporate learnings. Stakeholders include, but are not limited to Development Leads, Project Leaders, Regulatory Affairs, Operations, Global Customer Support, and Post-Market Quality.

The Opportunity

• Ensure consistent interpretation & implementation of global requirements across Customer Areas (CAs)

• 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

• Ensure development project plans contain the right deliverables according to the Design & Development module to deliver safe and compliant solutions

• Support internal and external audits

• Lead and facilitate constructive discussions e.g. at project team meetings

• Drive awareness and adoption of the Risk Enabler inside and outside of Global Quality & Regulatory decision making; prepare and enable risk-based decisions

• Partner to ensure effective resolution of issues (e.g. CAPA, NC)

• Ensure effective feedback loops and information flow for milestone review.

Who You Are

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

• 8+ years of experience in the diagnostics industry or a related field in business relatedfunctions

• Strong scientific and technical background with sound product knowledge, ideally with assay/reagents/system/hardware/software development experience for IVD Products.

• Strong business and financial acumen with an enterprise mindset

• Knowledge of Regulations pertaining to the environment (i.e. ISO 13485, ISO 14971, GDP, GMP, others)

• Excellent communication, presentation, and negotiation skills.

• Strong agile knowledge and capabilities demonstrating new ways of working

• Pragmatic decision making and ability to move forward without a perfect solution

• Demonstrated thorough E2E understanding for lifecycle management

• Strong leadership capabilities, with experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change.

Locations

You are located in Carlsbad, CA. This is a primarily onsite role.

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of Carlsbad is $103,800 and $221,780. 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.

Benefits

GenMark 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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.