Interview Studio

Requirements found

Compliance (must) Supply Chain Quality Assurance Training Project Management (must)

What this posting asks for

Level: Manager — The title says "Manager".

Main responsibilities

• Contribute to design documents, such as reagent stability plans, design inputs, design outputs, design verification protocols and reports while working close…
• Develop and execute detailed design transfer plans
• Lead and coordinate design transfer activities from R&D to manufacturing
• Lead test method development, characterization, and validation
• Lead cross-functional efforts to establish supply chain for raw materials and consumables;
• Ensure compliance with FDA, ISO 13485, and quality system regulations during design transfer and production
• Manage and provide leadership for scientists to ensure group effectiveness and development
• Monitor performance, deliver timely feedback, and support career development of direct reports
• Partner with Operations, R&D, Product Management, Quality Assurance, and Regulatory Affairs to ensure seamless design transfer and product launch
• Serve as the primary liaison between development and operations, ensuring knowledge transfer and training of operational staff

Competencies an interviewer will look for

• Communication Core
  In the posting: “The manager also will ensure robust processes, documentation, compliance with regulatory requirements, and cross-functional alignment.” · “Communicates progress directly with colleagues and senior management” · “Contribute technical and process documentation to regulatory submissions”
  Show it by: Adapts the message to the listener; Gives an example of explaining something clearly in writing or speech.
• Teamwork and collaboration Core
  In the posting: “The manager also will ensure robust processes, documentation, compliance with regulatory requirements, and cross-functional alignment.” · “Lead cross-functional efforts to establish supply chain for raw materials and consumables;” · “Actively participate in the project core team and program team meetings, provide project updates to cross functional teams and senior leadership”
  Show it by: Says what they did inside a team, not only what 'we' did; Shows how a disagreement was handled.
• Leadership and mentoring Core
  In the posting: “The role will be managing a multidisciplinary group of scientists, providing technical mentorship, and ensuring timely delivery of project milestones.” · “Design Transfer Leadership” · “utilize DOE, Cpk analysis, and Gage R&R, and mentor others in study design”
  Show it by: Describes setting direction or a standard others followed; Names someone they coached and what changed for them.
• Planning and organisation Core
  In the posting: “This role will plan, execute, implement, and document all design transfer activities for a next generation sequencing (NGS) IVD/PMA assay under Quality Syste…” · “Responsible for planning and managing activities and studies from late-stage development to launch” · “Strong project management and organizational skills”
  Show it by: Shows how priorities were set when everything was urgent; Mentions deadlines met and how.
• Data and analysis Core
  In the posting: “Routinely participate in risk management activities (such as hazard analysis, FMEA) to identify hazards and its causes and propose controls to mitigate risks” · “Works closely with bioinformatics / statistics groups in aligning with rationale for study designs and acceptance criteria” · “Conduct studies to generate specifications and set process/test method specifications based on statistical analysis”
  Show it by: Uses a number to describe the situation or the result; Explains what the data showed and what was done with it.
• Attention to detail and quality Core
  In the posting: “This role will plan, execute, implement, and document all design transfer activities for a next generation sequencing (NGS) IVD/PMA assay under Quality Syste…” · “The manager also will ensure robust processes, documentation, compliance with regulatory requirements, and cross-functional alignment.” · “Contribute to design documents, such as reagent stability plans, design inputs, design outputs, design verification protocols and reports while working close…”
  Show it by: Gives an example of an error caught before it caused harm; Names the check or standard they used.
• Problem solving Core
  In the posting: “Proficiency in experimental design, statistical data analysis, and technical problem-solving” · “Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted intervent…”
  Show it by: Describes a real problem, the options considered and the one chosen; Shows how the cause was found, not just the fix.
• Stakeholder management Core
  In the posting: “The manager also will ensure robust processes, documentation, compliance with regulatory requirements, and cross-functional alignment.” · “Contribute to design documents, such as reagent stability plans, design inputs, design outputs, design verification protocols and reports while working close…”
  Show it by: Shows how they aligned people with different goals; Explains how they handled a 'no' from someone senior.
• Technical skill Supporting
  In the posting: “The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many …”
  Show it by: Names the tools, languages or systems used and how; Explains a technical choice and its trade-off.
• Ownership and accountability Supporting
  In the posting: “Foster a culture of accountability, safety, compliance, and continuous learning”
  Show it by: Takes a task from start to finish without being chased; Owns a mistake and what was changed after it.
• Customer focus Supporting
  In the posting: “Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.”
  Show it by: Puts the customer's need in their own words; Shows a result for the customer, not only for the company.
• Adaptability and learning Supporting
  In the posting: “Collaborative, adaptable, and focused on achieving business and corporate objectives”
  Show it by: Describes learning something new quickly and using it; Shows a change of plan and how they adjusted.

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