Technical Product Lead (ePlex Assays)

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The Position

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 p