About the role :
As a Senior Scientist/ Senior Engineer, you will be a member of the Post-Market Complaint Investigation and Resolution Chapter. You report to the Sub-Chapter Lead of the Complaint Investigation and Resolution Chapter.
You will closely work with the Roche Diagnostics Solutions (RDS) Customer Areas or Disease Areas, RDS Global Functions (e.g. GCS, R&D, CDMA), and Global Functions (e.g. Global Operations), the corresponding Functional Partners within Global Quality & Regulatory (GQ&R) who link to Lifecycle Teams (LCTs), Roche affiliates, as well as collaborate across Networks to deliver comprehensive and successful resolution of global product complaints.
Furthermore, you will interact closely with the Chapters and Networks within PMQ to determine how to best meet the needs of our customers and patients.
Drive business results and customer value
- Deliver resolutions to our Affiliates with a customer and patient centric mindset
- Drive to meet your Network’s key objectives and the organization’s business strategy
- Ensure transparency across Squads and Chapters
- Work according to priorities set by networks
Advance the work of the Network, making tradeoffs and breaking silos
- Break down silos and improve working effectiveness as an ‘integrator’ across the organization as needed; in particular through collaboration with other Networks and Chapters
Empower and enable Squads within the Network
- Support Squad Leaders in defining acceptance criteria for Squad outcomes and provide feedback on work-in-progress as helpful to ensure alignment and autonomy
- Ensure Squads proactively seek out and consider the voice of the customer in defining their priorities and outputs
- Contribute to Squads as needed
Enable the organization’s New Ways of Working
- Incorporate behaviors to support the organization’s transformation to new, more Agile Ways of Working – e.g. new decision making/governance practices, collaboration, etc
- Embraces VACC leadership principles
Specific job accountabilities
- Accountable for the timely handling of individual cases (Inquiries, Complaints, 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.
- Resolves cases in the assigned area, potentially requiring consultation with more senior team members on technical or process-related aspects
- Analyzes data using statistical measures for determining a potential product performance issue.
- Responsible for escalating cases which cannot be directly resolved to appropriate levels and initiating further investigation and communicates case derived information as appropriate
- Assumes responsibility to ensure, by collaborating and interfacing with the BA and global functions, appropriate measures from cases are derived, including, but not limited to workarounds, in a timely manner.
- Initiates, monitors and ensures completion of complaint CAPAs and triggers appropriate preventive actions resulting from complaints.
- Assumes responsibility for timely communication of quality related information to the Country Organizations.
- Provides audit and inspection support as requested.
- Contributes 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 pro-active measures.
- Assumes responsibility to ensure risk assessments for product quality issues are complete.
- Supports regular review of quality of case handling, 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.
- Proficiency in English (B-level), expressed communication skills and intercultural competence.
- In Complaint Investigation and Resolution – Responsible for experimental design of complaint investigations, conducts investigation experiments. Partners primarily with internal Roche Global Functions (i.e. Operations, Research and Development, CDMA).
- Provides guidance and feedback to other case owners on the case handling processes and product technical knowledge.
- Participate in the on-boarding and mentoring activities of new employees and team members as assigned.
- Acts as leader/driver for subchapter initiatives and projects.
- May act as a proxy for a Principal role.
Candidate requirements :
- Have an interdisciplinary mindset, a high level of problem-solving oriented activity and customer orientation
- Bring a mix of passion, functional knowledge and customer-obsession to your work to inspire, motivate and guide Squads within the network
- Are committed to cross-functional collaboration and breaking down silos to achieve the best results for the organization
- Have the ability to navigate within a changing organization, maintaining objectivity, respect for differences of opinion, fairness, open communication and consensus building skill
- Deliver against the PMQ and GQ&R North Star
High degree of subject matter expertise:
- Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP)
- Have a minimum of 3 years of experience
- Possess Bachelor’s Degree of equivalent in the life sciences, engineering or related field.
- Problem solving and troubleshooting capabilities
- Good sense of urgency and engagement to act accordingly
- Root Cause analysis knowledge
- Experience working with global cross functional teams
- Solid communication skills (written and spoken) in English are essential
- Knowledge of additional languages is a plus
- Computer literate, with knowledge of e-learning, multimedia technologies
- Proficient in Technical Writing
- Genuine empathy, patience, flexibility and ability to skillfully direct contacts to resolve issues in a timely manner