Head Device Quality Complaint Operations
Join to apply for the Head Device Quality Complaint Operations role at Roche
Head Device Quality Complaint Operations
Join to apply for the Head Device Quality Complaint Operations role at Roche
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s What Makes Us Roche.
The Opportunity
The Device Quality Complaint Operations team is accountable for the Quality management of Global Complaints for stand alone medical devices (e.g. Port Delivery Platform) and device constituent part of combination products. The Chapter responsibilities also include global complaint operational activities (e.g. quarterly trending) and support of continuous improvement initiatives for the medical device complaint management process.
* You will develop the strategy and architecture for a scalable complaints process, ensuring the right infrastructure for risk-based decision-making. In addition, you will build a workforce with the right competencies to deliver on device-related priorities
* You will simplify processes and lead data governance in the complaints process to enable digital solutions such as AI and other automation technologies
* You will be the architect and lead all aspects of a complex outsourcing model for handling high-volume complaints. Hold end-to-end accountability for the Chapter team's performance and delivery
* You will ensure team members have the required proficiency to execute tasks and meet objectives. Promote continuous improvement and advance behavioral capabilities through coaching in new working approaches
* You will partner with other Chapter Leads to align on strategic priorities, accelerate decision-making, and support each other. Act as a strategic partner to stakeholders in PTQ and PT for organizational priorities
* You will develop and manage the annual budget, revising forecasts as needed and supervise expenditures for efficient resource use. Optimize the PTQ DQ operating model and identify organizational efficiencies
* You will advance inclusion and belonging within the team. Collaborate with other Chapter Leads for talent flow, succession planning, and addressing business requirements. Promote a safe environment for experimentation and autonomous contribution
Who You Are
* You hold a BA or BSc degree (or equivalent) in life sciences, Pharmacy, or a related scientific subject area
* And bring 12+ years of experience in a regulated industry such as pharma/biopharmaceutical or medical device, with 7 years in Quality, Compliance, Regulatory, and/or Validation (particularly in complaint and adverse event management). Possess a strong understanding of quality assurance concepts, including cGMP, GSDP, and GVP
* Your experience with medical devices, multiple manufacturing technologies, and understanding of product lifecycles is desirable, enhancing the ability to manage multiple technical challenges
* You much demonstrate significant experience in leading teams in a matrix environment. Show evidence of the ability to develop employees through lateral or promotional movements internally or externally
* It will be important in this role to adopt a mindset of inclusivity, speaking up, coaching others, focusing on outcomes, continuous learning, and shared accountability. Act as a Visionary, Architect, Coach, and Catalyst to foster a diverse and inclusive culture, connect people, and help achieve ambitious goals
Relocation benefits not eligible for this position
Genentech 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.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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