Quality Assurance Lead

Position:
Quality Assurance Lead – Indianapolis, IN Responsibilities

• Identify risk and evaluate deficiencies while working with internal departments/business units to appropriately remedy them.
• Facilitate internal training on quality assurance requirements, processes, and procedures.
• Perform evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Provide expert Quality support to US/RDC Commercial Operations and assist the organization with testing and monitoring of conformance to established quality assurance processes and standards.
• Develop and implement/eliminate quality strategies, policies and processes as needed, enlisting cross‑functional support to ensure RDC compliance.
• Be accountable for internal and external communications that adhere to corporate identity standards and regulatory/legal guidelines.
• Collaborate and establish productive cross‑functional partnerships within the US and globally as business needs arise.
• Lead or contribute to the resolution of complex quality and regulatory problems, identifying and mitigating risks.
• Manage or support quality and regulatory audits, monitoring and/or inspections, including preparing adequate and timely responses to any inspection observations and implementing appropriate corrections, as necessary.

• 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.
• Comprehensive understanding of Quality Management System regulations and policies.
• Strong analytical skills and ability to gather data, analyze information, create monitoring tools and manage diverse information across several corporate databases, repositories and enterprise applications.

Salary range: $103,900 – $192,900 (based on location). 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 provided link.

Roche 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, disability status, and consistent with all federal, state, or local laws.

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