Senior Scientist, Post Market Quality

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

A Senior Scientist - Post Market Quality, you will act as an escalation point for non-routine product complaints. This role will develop and update company complaint and inspection procedures to ensure capture and investigation of complaints. A Senior Scientist maintains and analyzes problem logs to identify and report recurring issues to quality assurance management and product development. This position will document and track contact information, report issues and problems in accordance with company guidelines and external regulatory requirements and may collaborate with other internal groups to respond to product inquiries and issues.

The Opportunity

• You are accountable for the timely handling of individual cases (Inquiry, Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements and regulations, and needs of the Country Organizations, including creation, acceptance, classification, investigation, complete documentation, on-site trouble-shooting and resolution of cases. You resolve cases in the assigned area.

• You collaborate and interface with the BA and global and/or local functions, suggest appropriate measures from cases are derived, including, but not limited to workarounds, in a timely manner.

• In Case Handling and Affiliate Support (CHAS) - Interface with Affiliates, assuming responsibility for timely communication of quality related information to the Country Organizations. Support initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives.

• In Complaint Investigation and Resolution (CIR) - Responsible for experimental design of complaint investigations, conducts investigation experiments. Partner with internal Roche Global Functions (i.e. Operations, Research and Development, CDMA).

• You analyze data using statistical measures for determining a potential product performance issue and assume responsibility for timely communication of quality related information to the Country Organizations.

• You ensure cases are compliant and conform to established quality processes, standards, and regulations. You support product teams by providing information from cases in order to update product documentation. You assume responsibility for ensuring risk assessments for product quality issues are complete.

• You ensure efficient laboratory organization and ensure compliance with laboratory policies. You ensure inspections of the responsible laboratory equipment and test equipment are done, including complete documentation.

• You may provide audit and inspection support as requested and may contribute to the creation of regular reports to document on-market product quality and performance, to escalate critical issues to the responsible Life Cycle Teams and to define proactive measures. And, may initiate complaint CAPAs and/or nonconformities and perform any assigned CAPA tasks.

• You may support regular review of quality of case handling and analyze feedback on customer satisfaction to permanently optimize processes to increase quality and efficiency standards with a focus on customer compliance and continuous improvement.

Who You Are

• You have a Bachelor's Degree in of life science, engineering, or a related field

• You have at least 3 years of work experience in a technical product support role, research and development setting, technical customer support role, product complaint handling or related function.

• You are proficient in Technical writing

Knowledge, Skills & Abilities

• You demonstrate strong customer service skills which include application of scientific knowledge and analysis, exceptional customer engagement, and fostering of customer relationships

• You have excellent written/verbal communication skills, , ability to work with multidisciplinary teams and foster collaborative relationships with internal and external stakeholders

• You are highly analytical and detail oriented, ability to multitask and effectively manage complex work processes in a fast paced, ever-changing, team-based environment

Locations

You are local to Branchburg, New Jersey. Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of Branchburg New Jersey is $70,000 and $130,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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