Principal Quality Manager, Global Medical Device Management (REMOTE)

South San Francisco - Off Campus
California, United States of America


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The Position

Location : Remote

POSITION SUMMARY

The Principal Quality Manager works independently and leads Supplier Quality Oversight from Supplier selection and design development phase to post commercial phase for purchased medical devices, medical device components and constituent parts for Combination Products(collectively referred to as Medical Device direct materials hereafter).

Main Purpose of the Position:    

  • Lead Device Supplier Quality oversight activities in accordance with the applicable regulations, guidelines, GMP and Roche standards.
  • Identify, Define and Implement Supplier corrective and improvement projects by proactively collaborating with Functions, Sites and Suppliers to enhance the quality and supply of Medical Device direct materials
  • Lead supplier development, gap closure and remediation activities to ensure successful supplier qualification, commercial GMP-readiness and sustainable GMP compliance
  • Evaluate and solve a wide range of complex issues that affect multiple functions and/or sites related to Medical Device direct material discrepancies, market complaints and associated investigations, in accordance with the applicable regulations, guidelines, GMP and Roche standards
  • Assess, and manage vendor initiated changes and third party actions for Roche initiated change in accordance with applicable regulations, guidelines, and Roche standards
  • Monitor and Trend the performance and risk level of assigned Suppliers
  • Drive continuous improvement objectives through end-to-end lifecycle management of processes and application of LEAN principles.

FUNCTIONAL RESPONSIBILITIES

  • Follow company policies and procedures
  • Accountable for behaviors as described in Roche Values and Core Competencies
  • Maintain a state of inspection readiness
  • Set personal performance goals after alignment with superior
  • Participate in the development of strategic goals and objectives for Global Supplier Quality
  • Establish work priorities to meet targets and timelines and independently manage competing priorities 
  • Operate as the Primary Quality Point of Contact to Suppliers for development and commercial products, and establish sound relationship with suppliers
  • Establish and maintain relationship and regular communication related to supplier performance, overall quality activity status with cross-functional development teams, Site teams and supplier quality management counterparts for allocated Suppliers
  • Apply advanced theory, technical principles, expert judgment and cross-functional expertise to independently address a broad range of complex problems
  • Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships
  • Identify and propose continuous process and system improvements applying LEAN principles
  • Lead and participate in the design and implementation of department and/or cross-functional initiatives.
  • Author or collaborate to author and/or revise department policies and procedures
  • Make decisions that impact the goals and objectives of the department
  • Sign documents for activities as authorized and described by Roche/Genentech policies and procedures 
  • Coach, train and oversee execution of quality outcome of assigned team members and/or Contractors
  • Perform any other tasks as requested by Management to support Quality activities

TECHNICAL RESPONSIBILITIES

  • Execute established SQM processes for supplier selection, approval and ongoing management to quality oversight level  
  • Support activities to ensure timely management of third party discrepancies, market complaints related to supplier quality issues, supplier-related changes in collaboration with stakeholders and subject matter experts to ensure thorough evaluation, risk assessment and accuracy of investigation, including but not limited to, identifying root cause, establishing corrective and preventive action plans, writing summaries, reviewing reference documents, and following company standards using the appropriate quality systems and tools.
  • Inform management and stakeholders of quality discrepancies and changes, provide timely impact assessments of potentially affected products, materials, or processes, and present at Material Review Board, including providing final Medical Device direct material disposition recommendations that may be affected by discrepancies
  • Participate in due diligence quality assessment and supplier audit program per established processes and timelines. 
  • Collaborate with IMP Device Quality and Device Development on device projects and ensure Supplier GMP-readiness for successful Supplier Qualification and introduction of new product. 
  • Lead implementation of Medical Device Management quality activities in accordance to project timelines. 
  • Assess, Monitor and Improve overall Supplier performance:
  • Conduct supplier site quality technical visits to review entire development and manufacturing processes and Quality Systems related to development and manufacturing of medical devices, device components and constituent parts for Device Combination Products
  • Maintain KPIs related data up to date, regularly input, review, consolidate and analyze Supplier Risk Score 
  • Identify and lead implementation of risk mitigation and risk reduction actions for medical device suppliers
  • Assess overall supplier capability of manufacturing process and controls and regularly review capability status
  • Propose and Lead improvement projects with suppliers as part of Supplier Management process to drive continuous improvement of the quality of medical device direct materials and services
  • Establish quality content of Supplier Specifications in partnership with Device Development, Sites and Supplier Quality counterparts and ensure timely approval of specifications
  • Prepare supplier quality performance review and escalation presentations and align key supplier messages with procurement and device development. Actively participate in designated collaboration meetings
  • Implement and lead joint tactical quality teams with suppliers as appropriate
  • Notify Senior Management of potential issues that may impact product quality or regulatory compliance  
  • Represent MDM at Device Category Management Team (CMT) meetings. Coordinate and compile data for periodic medical device supplier quality review.
  • Participate in building and deploying aligned Best Practices 
  • Collaborate with Commercial Device Quality to support DHF maintenance, post-launch design review, design changes and APQR quality risk assessments for medical devices and combination products  
  • Support site health authority and notified body inspections, internal audits, customer and health authority requests related to medical devices, as the medical device supplier quality SME
  • Perform other tasks as requested by management to support Quality oversight and MDM-related activities

QUALIFICATIONS

  • University degree in engineering, pharmacy, life sciences or equivalent 
  • At least 12 years of experience in the pharmaceutical or medical device industry in the area of Quality Assurance, Quality Control, Production or Development, or an equivalent combination of education and experience
  • Hands on expertise in medical device manufacturing
  • Demonstrated capability in applying risk management concepts and tools, and Design Control
  • Experience in the pharmaceutical/biotechnology industry, combination products, aseptic manufacturing and working in matrixed and global environments preferred 
  • Sound knowledge of Pharma and Medical Device GMPs, standards and applicable international regulations, including but not limited to, ISO 13485, ISO 14971, ISO 9001, 21 CFR Parts 4, 11, 210, 211, 820, EU Medical Device Directive
  • Ability to interpret and apply Quality Standards related to Roche products and suppliers
  • Understanding of primary container and drug product manufacturing processes, laboratory test methods to include EP, USP, JP requirements, and industry standards preferred
  • Demonstrated teamwork, collaboration and influencing skills and relationship management with third parties, and ability to communicate clearly and professionally both verbally and in writing. 
  • Demonstrated ability to negotiate successfully in difficult and complex environments
  • Demonstrated ability to lead small teams in a cross-functional matrix structure
  • Demonstrated problem solving and decision making skills including hands on working experience with basic statistical tools. Six Sigma / LEAN knowledge is preferred 
  • Knowledge in analytical methods and project management is beneficial
  • Knowledge and experience in TrackWise systems and SAP is a plus
  • Willingness to travel up to 25% (domestic and international travel)

This position is not eligible for relocation.

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.


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