Global MSAT Scientific Expert (Validation Master Data Manager and User Support)

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.

Who We are

At Roche, we believe it's critical to deliver medical solutions now - even as we develop innovations for the future. We are passionate about transforming patients' lives and we are fearless in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. You'll be working within the Manufacturing Science & Technology (MSAT) and Global Engineering group. As a key strategic enabling function for the Roche Manufacturing network, we support the changing product mix, new modalities and investments for our internal manufacturing capabilities and assets that ultimately bring the Roche pipeline to commercial production to deliver for patients.

The Opportunity

The Global MSAT Scientific Expert (Validation Master Data Manager and User Support) is a vital member of our Global MSAT & Engineering team (PTT) responsible for maintaining and updating the master data in a centralized paperless validation system at Roche and to provide critical user support within the Roche network. This role involves managing templates and ensuring standardization in our validation system, as well as handling data migration tasks, process change requests, and ensuring accurate record-keeping.

This position requires a strong understanding of the Qualification and Validation business processes, an innovative and problem solving mindset along with a strong ability to work collaboratively with interfaces to Global and Local MSAT, Engineering, Quality and IT organizations.

Key Responsibilities:

• Develop and implement validation strategies with global teams to ensure compliance with cGMP regulations and Roche's standards, while optimizing qualification/validation processes and maintaining accurate documentation.

• Collaborate cross-functionally with Quality, Manufacturing, Engineering, and other stakeholders, providing training and guidance on validation practices, managing change, and driving system adoption across all facilities.

• Oversee eVALRoche gSite maintenance: update content, remove or revise outdated material, manage template revisions, and ensure standardized templates, while organizing the site and eVAL g: drives in collaboration with IT and Project teams.

• Support user requests related to data migration using the ETL tool, maintain the Master Data Spreadsheet, manage monthly approval workflows, and offer daily user support through eVAL gChats, issue escalation, and change control processes.

• Lead communication efforts such as updating the monthly newsletter, maintaining Power Users and BPM lists, organizing ad-hoc meetings, and documenting requests and fixes to ensure continued best practices.

Who You are

You are someone who wants to influence your own development and can work independently, with limited supervision. You have 3-5 years of experience in the pharmaceutical or biotechnology industry, with a strong foundation in process development, operations, and manufacturing. Your background includes expertise in drug development, commercialization, and launch processes, along with a deep understanding of the complexities of supply chains, pharmaceutical quality systems, and product lifecycle management.

• Working knowledge in FDA CFRs, EMA regulations, and ICH guidelines, with a focus on regulatory compliance

• Demonstrated proficiency in validation methodologies, risk assessments, and maintaining associated documentation.

• Familiarity with Valgenesis Validation Lifecycle Management System is a plus.

• Hands on working experience in resolving issues related to project documentation, including business and functional requirements, validation protocols, and technical support documentation.

Preferred

• Experience in pharmaceutical systems: Skilled in requirements analysis, system design, implementation, and validation in 21 CFR Part 11-compliant GMP environments, with a focus on the pharmaceutical industry.

• Strong collaboration and leadership: Proven ability to build relationships with internal and external stakeholders, coach colleagues, and motivate teams while demonstrating Roche Values and Leadership Competencies.

• Problem-solving and decision-making: Capable of identifying opportunities, implementing solutions, and guiding others in effective risk-taking and decision-making to build skills and expertise.

• Excellent communication skills: Skilled in presenting to various audiences, synthesizing complex issues, and ensuring data accuracy and integrity while managing multiple priorities.

• Independent and self-motivated: Strong ability to manage commitments, facilitate virtual teams, and work independently with a focus on achieving objectives and delivering results.

Travel Requirements:

• Anticipated domestic and international travel: 20%

Relocation benefits are not available for this posting.

The ideal candidate will work out of our Indianapolis or Mississauga site or be located within the Eastern Time Zone to support global projects.

The expected salary range for this position based on the primary location of Indiana is $80,500 to $149,500. 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

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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.