Job Abstract

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.

Technical Product Lead (ePlex Assay)

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. 
 

The Opportunity:

• Accountable for assigned product

  • Technical end to end ownership of the ePlex Assay including KPIs such as performance and quality

  • Owner of product specification

• Reporting to the PCQT and responsible for leading the cross-functional Assay Product Team Meeting (PTM)

  • Defines and tracks with his/her Product Team the yearly cross-functional Product Care objectives, aligns these with impacted Functions & Stakeholders

• Drives cross-functional alignment between representatives from Production, R&D, GCS, CIR, Engineering, QA, Regulatory Affairs and Business Area (BA) functions

• Leadership of cross-functional PCQT and Operations projects as well as technical oversight of organizational program in collaboration with the project lead

  • Responsible for all underlying project management activities including planning (time, budgets, resources, quality), delivery of underlying work results, monitoring and tracking, reporting, alignment with involved functions within & outside the department

  • Leading holistic root cause analysis for quality and performance issues

• Supports the Product Care budget planning & reconciliation process

• Central point of contact for all lifecycle management activities for the assay, such as phase in/ phase out strategy of new suppliers

  • Responsible for the continuous Product Risk Management Process and resulting updates to the Risk Management File during the Post Launch phase until product phase out

  • Drives performance & quality for the product with involved disciplines & functions

• Is accountable for Product Issues and risks

  • Leads the Product Quality Committee (PQC) on request, acts as interface between PQC and Product Care (PC) Team

  • Responsible for executing the CAPA, Configuration & Change Management process for the assigned product portfolio

• Represent the product in internal and external audits

• Supports the continuous improvement of the Roche end customer experience

• Ensures a clear, strategic view on prioritization and OneRoche mindset

• Supports the Risk Assessment of the assay manufacturing processes (process-FMEAs) in close cooperation with the responsible Head of Production & Production Team Leads

Who You Are:

• Bachelors Degree in focus areas such as Finance, Operations management, Project Management or related degree

Preferred Qualifications:

• B.S. degree in the sciences/engineering; an advanced degree / Masters is preferred

• Ten or more (10+) years of experience in product care, production, development and/or related projects

• Proven record of cross functional project leadership and excellent root cause analysis skills

• Good understanding of the GenMark production process and the ePlex Assays

• Team-oriented personality with very good networked thinking and excellent collaboration skills

• Independent working style as well as very good communication and presentation skills

• High assertiveness, flexible, resilient and open personality

The expected salary range for this position based on the primary location of Carlsbad, CA is $126,000 - $234,000.  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.

Benefits

Relocation benefits are not available for this job posting.

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 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.