Senior Manager Business Intelligence, AI & Data Governance, CVRM

Genentech; Holly Springs (NC); Sur place; USD 133 000 - 248 000; Plein temps

Avantages offerts par ce poste

Relocation assistance

Annual bonus potential

Résumé du poste

Genentech in Holly Springs, NC seeks a transformational Enterprise Data & Analytics lead to design and deliver BI strategies for a state-of-the-art drug product facility. You will spearhead AI/ML initiatives, data governance, and data architecture across SCADA, MES, LIMS, and ERP systems to enable real-time decision making.

We look for 8+ years in pharma manufacturing with hands-on BI, data pipelines, and GxP compliance, plus strong leadership to mentor a growing team and partner with Quality

Qualifications

• 8+ years in pharmaceutical manufacturing, process engineering, automation, data analytics, or industrial digital transformation.
• Proven hands-on experience designing and building BI dashboards, analytics solutions, and data pipelines.
• Deep understanding of pharma plant operations and data architectures (IoT, MES, SCADA, historian systems).

Responsabilités

• Design, deploy, and build site-wide BI dashboards, analytics pipelines, and KPI frameworks.
• Lead AI/ML initiatives including predictive maintenance and yield optimization.
• Establish data governance policies and ensure FDA 21 CFR Part 11 and ALCOA+ compliance.

Connaissances

BI dashboards

Data pipelines

SQL/Python

AI/ML initiatives

GxP compliance

Leadership

Data analytics

Formation

Bachelor’s or Master’s degree in a technical field

Outils

AspenTech

Siemens

Ansys

Python

Description du poste

The Position

Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.

The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.

Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.

Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine.

What You’ll Do

1. Enterprise BI Strategy & Technical Delivery

• Design, deploy, and personally build site-wide BI dashboards, analytics pipelines, and KPI frameworks that support operational, quality, and executive decision-making
• Analyze plant data to proactively identify operational opportunities (yield optimization, cycle time reduction, energy efficiency, quality improvements) and partner with business functions to translate insights into action
• Co-design data visuals and analytics solutions with Operations, Quality, Engineering, and Warehouse teams, ensuring relevance and usability
• Establish and manage analytics time-to-insight standards, reducing lead time for operational reports and batch disposition analytics

2. Artificial Intelligence & Predictive Analytics

• Lead the execution of AI/ML initiatives including predictive maintenance, yield optimization, and real-time operator decision support
• Drive measurable improvements in batch yield, equipment uptime (OEE), or downtime reduction through predictive AI models
• Ensure AI model validation and governance align with GxP requirements

3. Data Governance & GxP Compliance Leadership

• Establish and enforce site-wide data governance policies, data lineage protocols, and data quality assurance mechanisms for all non-ERP data sources (SCADA, MES, LIMS, historian systems, IoT platforms)
• Ensure compliance with FDA 21 CFR Part 11 and ALCOA+ principles across data operations
• Lead data quality assurance mechanisms and maintain 100% adherence to GxP/ALCOA+ standards
• Partner with Quality Assurance and Compliance teams to align data integrity protocols and AI validation strategies
• Establish data governance norms for the site, defining standards for data collection, storage, access, and usage

4. Data Architecture & Integration

• Partner with IT/OT teams to design and oversee integration of data pipelines across SCADA, MES, LIMS, and ERP systems into a unified analytics data layer
• Collaborate on architectural decisions that ensure scalability, security, and regulatory compliance
• Monitor data integration completeness and drive continuous improvement in system connectivity

5. Team Leadership & Development

• Build, mentor, and lead a high-performing team of data engineers, BI developers, data scientists, and data governance specialists
• Foster a culture of technical excellence, continuous learning, and cross-functional collaboration
• Provide hands-on technical mentoring and code reviews; model best practices in design, analysis, and execution
• Develop team members' technical and leadership capabilities through coaching and growth opportunities

6. Value Tracking & Business Growth

• Establish clear KPIs to quantify business value across BI, AI, and Digital Twin initiatives (e.g., reduction in batch cycle time, lower deviation rates, reduced energy consumption, improved OEE)
• Regularly report metrics and ROI to site leadership
• Proactively scout new manufacturing use cases, ROI opportunities, and continuous improvement projects to expand the Digital Twin's footprint and analytics capabilities

Who You Are

• B.S. or M.S. in Chemical Engineering, Mechanical Engineering, Data Science, Computer Science, Industrial Automation, or a related technical field
• 8+ years of experience in pharmaceutical manufacturing, process engineering, automation, data analytics, or industrial digital transformation
• Proven hands-on experience designing and building BI dashboards, analytics solutions, and data pipelines (SQL, Python/R, or equivalent)
• Hands-on experience with simulation, Digital Twin solutions, or advanced data modeling—demonstrating ability to drive insights and operational improvements Deep understanding of pharma plant operations (GMP, batch process control, PAT) paired with familiarity in data architectures (IoT, MES, SCADA, historian systems, simulation software like AspenTech, Ansys, or Siemens)

Product & Program Management:

• Proven track record in managing product lifecycles, backlogs, and use case prioritization with demonstrated ability to translate complex business requirements into prioritized, actionable deliverables
• Strong background in building business cases and demonstrating value realization through data-driven metrics

Data Governance & Compliance:

• Experience establishing and enforcing data governance policies, data lineage, and quality assurance mechanisms in GxP-regulated environments
• Demonstrated expertise in FDA 21 CFR Part 11 and ALCOA+ compliance
• Experience leading data governance initiatives outside of ERP systems

Leadership & Stakeholder Management:

• Demonstrated success in cross-functional stakeholder management, effectively bridging communication between technical teams, operations, engineering, and quality functions
• Ability to lead, mentor, and develop high-performing technical teams

Experience driving organizational adoption of new technologies and methodologies

• Certifications (Preferred):

Certifications (Preferred):

• Agile/Scrum Product Owner (CSPO/PSPO)
• Lean Six Sigma (Green or Black Belt)
• Project Management Professional (PMP)
• GxP/ALCOA+ compliance certification or training

Relocation assistance is available for this role.

The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $133,400 - $247,800. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Benefits

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.