Offers “Roche”

Expires soon Roche

Principal Scientist, Case Investigation Resolution

  • Santa Clara (Santa Clara)
  • IT development

Job description



·  Job facts

Essential Job Functions:

·  Assumes accountability for the timely case management of individual cases (Inquiries, Complaints, PRI/PSIs) according to regulatory and ISO Quality system requirements and needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation and resolution of cases.
·  Supervise, provide guidance and feedback to other case owners on the case handling processes and product technical knowledge.
·  Responsible for experimental design of complaint investigations to ensure an efficient, timely approach for determining a product performance issue. Provides guidance on experimental design approach to other case owners.
·  Conducts investigation experiments and analyzes the data, using statistical measures, for determining a potential product performance issue. Provides guidance on experimental design approach to other case owners and may supervise investigation activities performed by others.
·  Ensures, by collaboration and interfacing with BA, Stakeholders and global functions, that appropriate technical input and recommendations are communicated to Country Organizations ensuring that the customer is provided with a resolution or workaround in a timely manner.
·  Initiates and monitors complaint CAPAs/NCRs and triggers appropriate preventive actions resulting from complaints. Works in collaboration with stakeholders from other functional areas.
·  Accountable for providing information from cases to update product documentation.
·  Accountable for timely communication of quality related product information to cross functional key stakeholders, including Country Organizations.
·  Creates and maintains enhanced interfaces with Country Organizations, regional representatives and other cross functional stakeholders.
·  Accountable for regular peer review of escalated cases and providing feedback and guidance to other case owners on expected documentation practices.
·  Oversees complaint databases to identify and report recurring issues to quality management and product development.
·  Conducts root cause analysis of complaint cases requiring corrective action. May represent the CIR on the CAPA team to ensure that corrective measures and deviations meet acceptable quality standards.
·  Supports and represents the CIR department in audits and inspections by ensuring cases are compliant and conform to established quality processes, standards, and regulations.
·  Creates, and supervises the creation of regular complaint reports, including trending, statistical analysis and related, to document on-market product quality and performance. Escalates critical issues to the responsible Life Cycle Team and may propose proactive measures. Provide guidance to other case owners on reporting creation processes.
·  Performs case-related trending to understand the scope of an issue.
·  Performs regular reviews of case handling and documentation quality, CAPA management and analyzes feedback on customer satisfaction to permanently optimize processes to increase quality and efficiency standards with a focus on customer, compliance and continuous improvement.
·  Assumes responsibility for on-boarding and mentoring of new employees and team members.
·  May participate in people management, direct or indirect reports, which includes feedback on hiring/firing decisions, interviewing, selection, performance feedback, discipline, pay decisions and handling employee grievances/complaints.
·  Represent the CIR on new product development projects (design control projects). Contribute CIR requirements are fulfilled and communicate project relevant information back to the department. Ensure CIR is prepared and trained to support products at product launch.
·  Represent the CIR on key cross team meetings and projects. Prepare relevant reports or documents as required for the specific team or project as required, and contribute as a proactive, collaborative team member.
·  Acts as team lead for department initiatives / projects.
·  May act as proxy for Department Manager.
·  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.

Education:
Minimum (required): Bachelor degree of life science, engineering, or related field, or equivalent combination of education and work-related experience
Preferred: Advanced degree (MS, PhD) in Molecular Biology, Microbiology, Genomics, NextGen Sequencing, Chemistry, Bioinformatics or related sciences.

Job-related Experience:
Minimum (required):

·  8+ years of work experience in a technical product support role, research and development setting, technical customer support role, product complaint handling or related function
·  Proficient in Technical writing

Preferred:

·  Solid knowledge and experience with Molecular Biology (including PCR technology), NextGen Sequencing applications and techniques
·  Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485)
·  Prior experience with product complaint handling, post market surveillance regulations
·  Solid problem solving and troubleshooting capabilities
·  Experience working with global cross functional teams
·  Experience leading a team/project, including cross functional project teams
·  Bioinformatics knowledge, including experience with short read NGS data, including standard pipelines (eg. bwa, samtools, GATK, Varscan etc.), variant detection algorithms, variant annotation and QC metrics, experience in a high level scripting language (e.g. Python, R, Perl)
·  Knowledge of the diagnostic market

Other Qualifications:

·  Strong communication skills in English (written and spoken) are essential; knowledge of additional languages is a plus
·  Detail and technical orientation, with robust analytical and organization skills, problem solving, troubleshooting capabilities and negotiation attitude
·  Demonstrated analytical, solutions oriented and collaborative approach to problem solving
·  Product and project risk management knowledge
·  Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP)
·  Prior experience and knowledge of new product development processes (product design control)
·  Computer literate, knowledge of e-learning and multimedia technologies
·  Genuine empathy, patience, flexibility and ability to skillfully direct contacts to resolve issues in a timely manner
·  Strong customer advocate and business orientation
·  Conflict management knowledge
·  Excellent presentation and communication skills
·  Certified in lean and six-sigma quality methodologies and utilize quality tools to help drive continuous improvement

·  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.

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