Department Head Diagnostics Product Support

Job description

  Job facts

Job Summary:
The Department Head will lead a dedicated team of highly qualified complaint handling specialists that drive case investigation and resolution for our Next Generation Sequencing (NGS) and Non-invasive Prenatal Testing (NIPT) product portfolio. This position has full accountability for the management of complaint processing and documentation of individual cases (inquiries, complaints), according to regulatory and ISO Quality system requirements, and supporting the needs of the country organizations, in a timely manner and in accordance with company standards and quality systems.The Department Head provides tactical direction, decision making, leadership and planning, including the efficient and effective use of resources.

This is accomplished through
·  Execution of a tactical plan in alignment with the strategic vision to meet compliance and efficiency objectives within the team;
·  Implementation and maintenance of harmonized case handling processes and procedures within the team;
·  Building a strong interface with country and global organizations (e.g. Manufacturing & Operations, Research & Development, Quality & Regulatory, Marketing),
·  Performance metrics and continuous improvement projects

The department ‘Case Monitoring and Resolution' is the Center of Excellence for the resolution of global product issues and monitors effective resolution of global and local cases ensuring optimal levels of customer satisfaction and regulatory compliance.

Within Case Monitoring and Resolution (CMR), the Department Head for the Roche Sequencing Solutions (RSS) Case Investigation and Resolution (CIR) is accountable for the following key responsibilities:

Essential Job Functions and Major Contributions:
·  Team leadership of highly qualitified complaint hanlding specialist.Responsible for complaint management, investigation and end to end resolution of complaints and inquiries for ourSequencing and Non-invasive Prenatal Testing product portfolio.
·  Executes the tactical plan in alignment with the Case Monitoring and Resolution (CMR) strategic vision to meet compliance and efficiency objectives within the team.
·  Implements harmonized Case Resolution processes and procedures, with a focus on product complaint handing and investigations, within the team in accordance with the overall agreed upon process.
·  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.
·  Sets functional goals aligned to those defined by Case Monitoring and Resolution and the assigned business area.
·  Develops people and fosters an open and transparent culture in accordance to the Roche Leadership commitments.
·  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.
·  Builds effective relationships with Country Organization, business area teams and 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.

Additional Tasks, Duties & Responsibilities:
·  Represents the S CIR team in the Case Investigation and Resolution Leadership Team (RSS CIR LT)the extended CMR Leadership team (CMR eLT).
·  Permanently optimizes the case handling and investigation processes and the communication to Country Organization and BA teams to increase quality and efficiency standards of the CIR team.
·  Performs regularreviews 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 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).
·  Develops and drives a work culture committed to customer focus, compliance and continuous improvement.
·  Reports to Head of CIR Roche Sequencing Solutions on the key performance measures of complaints and inquiries processed and investigated by the team.
·  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.

For All Employees:
Permanently optimize processes to increase quality and efficiency standards.

People and Financial Management
·  Responsible for direct management of a department of up to 12 employees.
·  Responsible for financial management of the department operating budget.
·  Travel requirements of approximately up to 25%.

·  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.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at .
EEO is the Law

PAY TRANSPARENCY NONDISCRIMINATION PROVISION
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Desired profile

Who you are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Education and Experience:
·  University degree in Life Sciences (molecular biology, genetics, medical technology or similar), related technical discipline (bioinformatics, engineering) or equivalent professional experience is required. Knowledge of next-generation sequencing, genomics, non-invasive prenatal testing technology, applications and markets is highly desirable.
·  Minimum two years of experience managing a department and proven effective people leadership.
·  Expert knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g. 21CFR 820,198, ISO 9001, ISO 13485, etc.).
·  Experience in the area of Medical Devices / IVD products in either 1st or 2nd level support or R&D/QC related functions and sound knowledge of the diagnostic market is highly preferred
·  Proven strong interpersonal skills with an analytical, collaborative approach to problem solving.
·  Proven success in translating strategy to implementation across teams

Other Qualifications & Competencies:
·  Inspiring and influencing
·  Understands what motivates other people to perform at their best
·  Connects with people in ways that ignite enthusiasm and commitment
·  Finds opportunities to build community celebrate and have fun
·  Managing Change:
·  Effectively manages change, explaining the context, answering questions, and patiently listening to concerns. Leads change by example.
·  Achieving Results
·  Clearly conveys objectives, deadlines and expectations
·  Aligns team resources to accomplish key objectives
·  Recognizes and rewards hard work and dedication to excellence
·  Recognizes individuals for progress as well as success
·