Quality Manager, Global Medical Device Management (MDM)- 1 Year Contract
Function: Global Supplier Quality (GSQ), External Quality
Department: Global Medical Device Management (MDM)
The Quality Manager works independently and leads Supplier Quality Oversight from Supplier selection and design development phase through commercial phase for purchased and customized medical devices, medical device components and constituent parts for Combination Products (collectively referred to as Medical Device direct materials hereafter) and GxP services associated with development, clinical and commercial supply chain of medical devices and device combination products.
· Lead Device Supplier Quality oversight activities
· Evaluate and solve a wide range of complex issues that affect multiple functions or sites related to direct material discrepancies, market complaints and root cause investigations
· Monitor and Trend the performance and risk level of assigned Suppliers
· Identify, Define and Implement Supplier corrective and improvement projects by proactively collaborating with Functions, Sites and Suppliers to enhance the quality and supply of direct materials through application of LEAN principles
· Create, Negotiate and Maintain Supplier Quality Agreements
· Participate in due diligence assessment for Supplier selection, lead Supplier qualification and maintain its approved state through consistent satisfactory performance.
· Initiate, assess, and manage vendor-initiated changes and supplier actions for Roche-initiated changes in accordance with applicable regulations, guidelines, and Roche standards
· Execute established Supplier Quality Management processes for supplier selection, supplier approval and lifecycle quality oversight
· Ensure timely management of third party discrepancies and market complaints related to supplier quality issues in collaboration with stakeholders and subject matter experts to ensure thorough evaluation 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 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 and Quality Review Board, as applicable
· Manage Vendor-initiated changes and Supplier related actions for Roche-initiated changes through interactions with suppliers, internal customers, and subject matter experts
· Lead and/or participate in due diligence quality assessments. Support audits of medical device and software as medical device (SaMD) suppliers according to the Supplier Quality Management Audit Program.
· Assure Supplier GMP-readiness for successful Supplier Qualification and introduction of new product. Lead Medical Device Supplier Quality activities in accordance to project timelines.
· Perform Supplier Quality Risk Assessments (QRM), drive mitigation actions and continuous improvement initiatives for Supplier performance and execution capability
· Lead Quality Agreement negotiations with medical device suppliers, and ensure Quality Agreements are maintained according to PQS requirements
· Lead joint tactical Quality teams (JQT) meetings with suppliers
· Represent MDM at Device Category Management Team (CMT) meetings
· Assure establishment of appropriate 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, escalation presentations, key supplier messaging
· Notify Management of potential issues that may impact product quality or regulatory compliance
· Collaborate with 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
· University degree in engineering, pharmacy, life sciences or equivalent discipline
· At least 6 years of experience in the pharmaceutical or medical device industry in the area of Quality Assurance, Quality Control, Production or Development
· Demonstrated capability in applying risk management concepts and tools, and understanding of Design Control
· Hands on experience in medical device manufacturing is preferred
· Understanding of primary container and drug product manufacturing processes, laboratory test methods to include EP, USP, JP requirements, and industry standards is preferred
· Experience in the pharmaceutical/biotechnology industry, combination products, aseptic manufacturing and working in matrixed and global environments is 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 (to be replaced with EU MDR in May 2021)
· Ability to interpret and apply Quality Standards related to Roche products and suppliers
· 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 and LEAN principles.
· 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 15% (domestic and international travel)
Qualified candidates are encouraged to submit cover letter and resume no later than March 5, 2021.
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process
AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.