Process Technical Lead - Infrastructure Quality

Roche • Indianapolis, IN

1d • $135,500 - $251,600 • Onsite

About The Position

This role is based in the Global Quality & Regulatory Network, which together with our partners in R&D, operations and supply chain, ensures that our products are available to healthcare systems in the highest quality and in sufficient quantities. This is our contribution to the prevention and diagnosis of diseases for the benefit of many hundreds of millions of patients worldwide. We at Global Quality & Regulatory are a global team that operates along the entire value chain. Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is every patient’s right and every employee’s responsibility. Global Operations Quality is part of the Global Quality & Regulatory Network and is therefore a key partner for internal and external organizations. We ensure the fulfillment of global quality and regulatory requirements. Our Product & Data Quality Chapter is accountable for delivering all aspects of the Product Quality function on an on-going basis in line with the Quality Management System to ensure that the data driven quality is deeply embedded within the organization to meet customer expectations and ensure compliance with applicable and regional regulatory requirements.
As Process Technical Lead - Infrastructure Quality, you are responsible for standardizing and enhancing Infrastructure Quality practices across Global Quality and Regulatory teams and DIA Partners. This includes managing equipment & infrastructure Q&V, change control, nonconformance management, quality support for Global Customer Support, audit support, and process monitoring. Your work ensures consistent partnership quality and predictable interactions. You align quality practices with business goals by defining enablers, participating in solution definitions, and managing capacity, ensuring effective communication and implementation. You collaborate strategically with Operation Quality Chapters and Networks to drive capability development, ensure knowledge sharing, and foster sustainable work practices. You develop a strategic vision and tactical plan to manage cross-network collaboration efficiently. By partnering with Network Leadership and the Quality System Excellence Chapter, you improve productivity, reduce costs, and standardize processes, leveraging deep knowledge of matrix organization structure for effective knowledge management and collective intelligence.

Requirements

• Bachelor’s / Master degree in Life Science, Pharmacy or related subject.
• Demonstrated experience and knowledge of Quality Operations and processes.
• At least seven (7) years in the Medical Device/Pharma/Biopharmaceutical industry with 5 years working in Quality, Compliance, Regulatory and/or Validation, preferred or equivalent experience.
• Excellent knowledge of the European, US, China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards.
• Demonstrated experience in European, US and other relevant Health Authority inspections.
• Strategic Thinking: Identify improvement opportunities and create actionable plans. Analytical skills to identify root causes and drive continuous improvement.
• Matrix Leadership: Influence, coach, and develop talent in a matrixed organization.
• Proven track record of leading change initiatives in dynamic environments.
• Process Modelling/Engineering: Defining, implementing, and improving business processes.
• Modeling agile mindset and utilizing agile methodologies.

Nice To Haves

• Advanced degree is considered an advantage.

Responsibilities

• Managing equipment & infrastructure Q&V, change control, nonconformance management, quality support for Global Customer Support, audit support, and process monitoring.
• Aligning quality practices with business goals by defining enablers, participating in solution definitions, and managing capacity, ensuring effective communication and implementation.
• Collaborating strategically with Operation Quality Chapters and Networks to drive capability development, ensure knowledge sharing, and foster sustainable work practices.
• Developing a strategic vision and tactical plan to manage cross-network collaboration efficiently.
• Improving productivity, reducing costs, and standardizing processes by partnering with Network Leadership and the Quality System Excellence Chapter.
• Develop strategies to enhance skills and knowledge.
• Establish best practices to meet compliance and business needs.
• Identify opportunities for process standardization and simplification.
• Lead efforts to reduce costs and increase efficiency.
• Train and mentor quality partners and leaders.
• Partner with Network leadership to develop empowered SMEs.
• Define and execute short and long-term capability needs.
• Build strong collaborative relationships across networks.
• Model Agile and VACC behaviors to support organizational transformation.
• Partner on QMS strategic direction and capability development.
• Lead process improvements considering cost, compliance, and complexity.
• Ensure consistency and alignment in mQMS execution.
• Champion continuous learning and growth aligned with strategic goals.
• Establish a system for effective knowledge creation, sharing, and utilization.

Benefits

• Relocation benefits are not available for this position.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior