Quality Assurance Lead

About the role

The Quality Assurance Lead position is part of Roche's commitment to ensuring patient safety and providing accessible healthcare. This role is based in Indianapolis, IN.

Responsibilities

• Identifies risk and evaluates deficiencies, working with internal departments to address them
• Facilitates internal training on quality assurance requirements, processes, and procedures
• Performs evaluations of internal controls, communications, risk assessments, and maintains documentation to ensure compliance with safety, quality, and regulatory standards
• Supports US/RDC Commercial Operations in testing and monitoring conformance to established quality assurance processes and standards
• Develops and implements quality strategies, policies, and processes as needed, with cross-functional support
• Manages or supports quality and regulatory audits, monitoring, and inspections, including preparing responses to inspection observations and implementing corrective actions
• Leads or contributes to the resolution of complex quality and regulatory issues, identifying and mitigating risks
• Ensures internal and external communications adhere to corporate identity standards and regulatory/legal guidelines
• Establishes and maintains productive cross-functional partnerships within the US and globally as needed

Requirements

• Bachelor’s degree and 8+ years of quality or training/learning experience OR 12+ years of related experience
• Excellent problem-solving, customer service, negotiation, interpersonal, decision-making, leadership, and communication skills
• A comprehensive understanding of Quality Management System regulations and policies
• Strong analytical skills and problem-solving ability

Qualifications

• Proven experience in quality assurance or related field
• Experience with regulatory compliance and quality management systems
• Ability to work independently and as part of a team
• Strong attention to detail and organizational skills
• Effective communication and collaboration skills

Skills

• Quality management systems knowledge
• Compliance with regulatory and safety standards
• Problem-solving and critical thinking skills
• Leadership and team management skills
• Communication and interpersonal skills

Benefits

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.