Genentech

Digital Quality Strategy Delivery Lead - Pharma Technical Operations

Genentech$118K — $155K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • BS/MS in Science or Engineering with 10+ years in digital transformation or tech-focused roles in pharma.
  • 5+ years as a Product Owner with strong leadership, stakeholder management, and communication skills.
  • Extensive experience in Agile product ownership and Organizational Change Management.
  • Deep understanding of GxP compliance, risk management, and quality systems.
  • Familiarity with GenAI technologies, including NLP and predictive analytics.

Responsibilities

  • Drive digital technology strategy in Quality via key initiatives and use cases.
  • Act as a digital translator between business needs and technical roles.
  • Define impact aspirations and lead global solution deployment within functions or sites.
  • Conduct detailed requirements analyses balancing process and stakeholder needs with product simplicity.
  • Facilitate compliant data and digital solutions in GxP environments.
  • Identify risks in digital quality initiatives and devise mitigation strategies.
  • Continuously assess emerging technologies to drive innovation in the Quality domain.

Benefits

  • Collaborative and inclusive team culture.
  • Opportunities for professional growth and development in digital and lean operations.
  • Engagement in groundbreaking projects with a focus on patient outcomes.
  • Access to advanced technologies and research initiatives.
Full Job Description
The Position

We advance science so that we all have more time with the people we love. At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. An integral part to achieving this vision is to deliver new and innovative data analytics solutions to our scientists across Pharma Technical Operations (PT).

To do so, we have formed a new organization called PT Digital and Operational Excellence (PTE) with the aspiration to build industry-leading digital and lean operations across functions and our entire manufacturing footprint.PTE is the organization that catalyzes global development and execution of PT’s Digital and Operational Excellence strategy to enable PT to realize our performance promises. We build a strong cross-functional and inclusive community, put the power of data into the hands of our people, further develop the Lean and Digital skills across PT, and scale up our Digital and Advanced Analytics solutions, for the benefit of our colleagues and patients. We aim to activate data citizenship and digital mindset, revolutionize our FAIR data ecosystem and systems landscape, re-design excellent processes, and generate transformative insights. 

The Opportunity

You will be responsible for driving the digital technology strategy through the delivery of key digital initiatives and use cases in the Quality domain and you take the role of an Agile Product Owner (PO) to partner with customers across PT functions to architect the planning (e.g. diagnose), execution (e.g. design & build), and sustainment of digital solutions to achieve the PT Digital Aspirations.

  • Strategic Digital Transformation: Architecting key initiatives and acting as a digital translator between business needs and technical roles by navigating across both domains seamlessly.

  • Impact: Defining impact aspirations (e.g. product vision, roadmap, value assessments, business cases) as well as leading deployment of a global solution in a function or site. Enable significant improvements in quality management processes through innovative digital solutions, confirmed through the measurement of key business metrics.

  • Requirements Analysis: Utilize your broad Quality end to end Business understanding to perform detailed requirement analyses with the team, with a strong focus on balancing process requirements, stakeholder requirements with digital product simplicity, network scalability and sustainability.

  • Prioritization and Team Setup:Conducting use case prioritization and assuming the product owner role to catalyze the implementation of key digital use cases. Coach teams that are developing and deploying digital use cases, e.g. share best practices, agile ways of working, backlog management, sprint planning and ensure full impact capture & coordination between different initiatives. Lead cross-functional project teams with digital experts and SMEs across multiple sites and time zones.

  • Compliance and Solution Shaping: Facilitating compliant solutions for data and digital products in the GxP environment.

  • Risk Assessment and Mitigation: Identify potential risks associated with digital quality initiatives and develop strategies to mitigate these risks.

  • Innovation and Improvement: Continuously explore and assess emerging digital technologies and industry trends. Drive innovation and process improvements within the Quality domain to enhance efficiency and effectiveness.


Who you are


You bring several years of experience in architecting and implementing digital transformations, preferably in the pharma industry and you are looking for an impactful role. We are seeking an individual with excellent knowledge of the pharma digital & data ecosystem, in-depth expertise in regulatory, supply chain and quality information systems, tools, and techniques. This entails a good understanding of the customers’ business’ challenges, goals and operations environment.

  • BS/MS in Science or Engineering Field with a minimum of 10+ years of related experience in leading digital transformation or technology-focused organization and solid understanding of the pharmaceutical industry with previous experience in quality systems elements, e.g. in the areas of Deviation- and Change Management, Quality Data Insights, Quality Oversight including GxP and Computerized System Validation (CSV).

  • 5+ years in leadership / Product Owner roles, with exceptional team and stakeholder management, communication, and analytical skills, e.g. value assessments, running diagnose phases and delivering technology solutions embedded into the business process.

  • Strong experience as Agile Product Owner with proven experience in Organizational Change Management (e.g. ADKAR), systems / data management, working with IT and the ability to influence senior leaders, as well as competence in risk management practices and compliance audits within the pharmaceutical industry

  • Solid understanding of GenAI technologies and their application in quality management, including NLP, predictive analytics, and automation.

  • A results-driven and proactive individual skilled in identifying solutions, leading cross-functional project teams and managing transformation initiatives

**Relocation not eligible for this position***

The expected salary range for this position based on the primary location of Mississauga is 118,560.00 and 155,610.00 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.

We use artificial intelligence to screen, assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

About Genentech

Genentech is a biotechnology company that develops and manufactures drugs for the treatment of serious medical conditions. The company was founded in 1976 and is headquartered in South San Francisco, California. Genentech's products include treatments for cancer, multiple sclerosis, and other diseases. The company is a subsidiary of Roche, a Swiss pharmaceutical company. Genentech has been recognized for its innovative research and development, and has received numerous awards for its contributions to the biotechnology industry.
Learn more about Genentech
Size
14,000 employees
Industry
Founded
1976

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