Department Head CIR RMD Virology (Westwood)

Employment Type

: Full-Time

Industry

: Healthcare - Allied Health



At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Department Head CIR RMD Virology
United States of America, New Jersey, Branchburg
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Within Case Monitoring and Resolution (CMR), the Department Head for the Roche Molecular Diagnostics Reagents Case Investigation and Resolution (CIR) is accountable for the following key responsibilities:
Job Summary:
Leads a functional team of complaint handling specialists / product technical experts responsible for execution of complaint management, investigations and end to end resolution of product complaints for a defined RMS product line(s), including analysis of product complaint trends, CAPA initiation, and audit preparations, as defined by the Roche Diagnostics Divisional Standards for Post Market Surveillance, together with the assigned Quality Management System and regulations for the products. Serves as the process leader on global complaint management and resolution initiatives related to product support, case investigations, case documentation, reporting, audits and other related activities. Manages and drives the CIR organization and strategy by working in close conjunction with global and local team leaders to influence decisions that affect Roche products and post market surveillance compliance.
Serves as the decision maker, for the business area, as the CIR representative on Life Cycle Teams (LCTs), International Business Teams (IBTs) and Project Teams. Responsible for proactive communication and effective stakeholder management with affiliates, specific business units, Lifecycle Teams (LCTs) and Global Functions towards achieving excellence in complaint management. Executes the tactical plan in alignment with the Case Monitoring and Resolution (CMR) strategic vision to meet compliance and efficiency objectives within the team. Is a member of the CMR extended Leadership Team (CMReLT).
Responsibilities:
* Leads and manages a team of highly specialized employees that provide:
+ Global Complaint Handling Support to Subject Matter Experts (Affiliates, Regions)
+ Complaint Investigation, Analysis and end-to-end resolution of escalated complaints
+ Audit ready, regulatory compliant processes and interfaces with global function stakeholders
+ Voice of the Customer and Subject Matter Expertise on new product development projects of novel high tech life science products
* Implements and manages harmonized Case Resolution processes and procedures, with a focus on product complaint handling and investigations, within the team in accordance with the overall agreed upon process. Ensures that case handling issues that may jeopardize the regulatory status of the Business Area and/or Division are handled with the necessary priority and urgency. Escalates issues to the BA and/or Division as applicable.
* Sets functional goals aligned to those defined by Case Monitoring and Resolution and the assigned business area. Has full understanding of team results, CMR charter, team performance to defined KPIs.
* Strives to deliver the divisional strategic solutions approach, in the Business Area, as well as across business areas.
* Manages staff; provides staff with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations. Recruits, evaluates and hires new employees.
* Conducts performance appraisals, hiring, coaching and counseling, career development conversations and disciplinary actions of team members.
* Is responsible for developing the CIR team members to ensure that they are capable of performing the required tasks for the assigned products. Ensures that the team members have the technical knowledge to handle cases and that the regulatory requirements are understood and adhered to.
* Develops and drives a work culture committed to customer focus, compliance and continuous improvement. Fosters an open and transparent culture in accordance to the Roche Leadership commitments.
* Implements process improvements of case handling and communication that will enhance the efficiency, productivity and leads to timely case resolution.
* Is responsible for the initiation, and monitoring of the implementation of product modifications and developments resulting from cases, influencing the future of products in the field.
* Builds effective relationships and networks with Country Organization, business area teams, and global site stakeholders.
* Drives and coordinates initiatives to create awareness of critical and important cases and Country Organization concerns in the BA teams.
* Is responsible for the regulatory compliance and compliance to ISO Quality System requirements of the CIR team and business area.
* Communicates with executive level management on department achievements and challenges.
* Responsible for financial management of the department operating budget.
* The essential job functions and major contributions listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. Incumbents may be required to perform other duties as assigned.
Additional Tasks, Duties & Responsibilities:
* Represents the assigned CIR team in the extended CMR Leadership team (CMR eLT).
* Permanently optimizes the case handling and investigation processes and communication to Country Organization and BA teams to increase quality and efficiency standards of the CIR team.
* Performs regular reviews of case handling quality, documentation and CAPA management, and analyzes customer satisfaction feedback to optimize processes in order to increase quality and efficiency standards with a focus on customer, compliance and continuous improvement.
* Prepares reports and trending analysis of product cases for business, quality and site initiatives (Life Cycle Teams, Management Reviews, Product Care Quality Team).
* Travel requirements of approximately up to 20%.
Education and Experience:
Minimum Requirements:
* Bachelor degree in life sciences, Molecular Biology, Microbiology, Genomics, NextGen Sequencing, Chemistry, Bioinformatics, Engineering, Business, or a related discipline. Advanced degree preferred.
* Minimum 5+ years of work experience in a technical product support role, research and development or manufacturing role of medical diagnostic instrumentation and/or reagents, product complaint handling or related function.
* Minimum 2+ years of experience supervising teams, leading key projects, leadership initiatives or managing a department, and proven effective people leadership.
Preferred Requirements:
* Expert knowledge of varied regulatory requirements and quality management systems practices, especially in the area of complaint management (e.g. 21CFR 820,198, ISO 9001, ISO 13485, etc.)
* Prior experience with product complaint handling, post market surveillance regulations in a regulated environment
* Certified in lean and six-sigma quality methodologies and utilize quality tools to help drive continuous improvement
* Prior experience and knowledge of new product development processes (product design control)
* Proven strong interpersonal skills with an analytical, collaborative approach to problem solving
* Proven success in translating strategy to implementation across teams
* Knowledge of the diagnostic market, Roche experience preferred
* Multi-language and multi-cultural experience is a plus
Other Qualifications, Knowledge, Skills or Abilities:
* Excellent verbal & written communication and effective listening skills
* Proficient with MS Office tools, Google, Web-based conferencing tools
* Excellent presentation skills and ability to present to a diverse audience at all levels of the organization
* Ability to manage conflict and facilitate candid discussions, give and receive feedback
* Ability to understand team member's motivations, build trust, and foster teamwork
Travel Requirements: up to 10%
* Who we are
At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche 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.
* Job facts
+ Location United States of America, New Jersey, Branchburg
+ Function Quality
+ Subfunction Quality Assurance
+ Schedule Full time
+ Job level
+ Job type Regular
+ Division Diagnostics
+ Posted since 2019/10/24
+ Job-ID 201###-####02
* Get in touch
Mrs. Misha Bringuier

* Bachelor degree in life sciences, Molecular Biology, Microbiology, Genomics, NextGen Sequencing, Chemistry, Bioinformatics, Engineering, Business, or a related discipline. Advanced degree preferred. * Minimum 5+ years of work experience in a technical product support role, research and development or manufacturing role of medical diagnostic instrumentation and/or reagents, product complaint handling or related function. * Minimum 2+ years of experience supervising teams, leading key projects, leadership initiatives or managing a department, and proven effective people leadership. Preferred Requirements: * Expert knowledge of varied regulatory requirements and quality management systems practices, especially in the area of complaint management (e.g. 21CFR 820,198, ISO 9001, ISO 13485, etc.) * Prior experience with product complaint handling, post market surveillance regulations in a regulated environment * Certified in lean and six-sigma quality methodologies and utilize quality tools to help drive continuous improvement * Prior experience and knowledge of new product development processes (product design control) * Proven strong interpersonal skills with an analytical, collaborative approach to problem solving * Proven success in translating strategy to implementation across teams * Knowledge of the diagnostic market, Roche experience preferred * Multi-language and multi-cultural experience is a plus Other Qualifications, Knowledge, Skills or Abilities: * Excellent verbal & written communication and effective listening skills * Proficient with MS Office tools, Google, Web-based conferencing tools * Excellent presentation skills and ability to present to a diverse audience at all levels of the organization * Ability to manage conflict and facilitate candid discussions, give and receive feedback * Ability to understand team member's motivations, build trust, and foster teamwork


Associated topics: hematopathology, mlt, pathology, services, sterile processing technician, surgical technologist, technician ii, technician lab, technologist, testing

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