Demonstrates working knowledge of quality assurance systems, methods and procedures. An accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures.

The Internal Audit function provides independent, objective, reliable, valued and timely assurance regarding the effectiveness of governance, risk management, and internal controls that mitigate current and emerging risks and help strengthen the internal control's ecosystem.

Title: Manager/Senior Manager, Quality AssuranceReports To: Associate Director, Quality Assurance Operations Location: Redwood City, California Classification: Exempt Overview:The Manager/Senior Manager, Quality Assurance, represents the quality organization at Coherus and at Contract Manufacturing Organizations (CMOs) to ensure appropriate oversight/monitoring of production, and ensure continuous supply of clinical and commercial products.

Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Interact with key stakeholders such as Formulation and Process Development, Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that Clinical/Commercial material is manufactured in accordance with established procedures, cGMPs, and appropriate regulations.

Work closely with manufacturing, CMC and science teams on quality assurance tasks. Desired QualificationsProven experience (5+ years) in quality assurance, ideally within clinical-stage manufacturing for a biotech company.

The Staff Quality Assurance role for Beckman Coulter Diagnostics supports cross-functional core team members in the software product design and development lifecycle of the Microbiology Business Unit in West Sacramento, California.

Audit & Assurance Senior (Anywhere in US) Overview: We are a forward-thinking, full-service accounting firm providing modern solutions to businesses across the globe. We focus on comprehensive assurance, tax, and consulting services for our clients, and we provide our people and our community with the resources to lead meaningful and purposeful lives.

Proven track record of successfully leading quality assurance teams and driving continuous improvement initiatives in a pharmaceutical manufacturing environment. Collaborate with cross-functional teams, including Research & Development (e.g. clinical development, clinical operations), manufacturing, supply chain, and regulatory affairs, to ensure alignment and integration of quality assurance processes throughout the product lifecycle.

Interact with key stakeholders such as Formulation and Process Development, Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that Commercial / Clinical Drug Products are manufactured in accordance with established procedures, cGMPs, and to appropriate regulations.

We are seeking a Quality Assurance Manager who is hands-on engineering leader to build out a new team focused enhancing automation coverage and effectiveness across the Family of Apps. You will have a great influence on the whole quality assurance process and methodology for the product development.

Ensuring Compliance: The QA Manager ensures that all testing and quality assurance processes comply with industry standards and regulations. The ideal candidate is a quality assurance leadership expert with strong communication skills and previous experience as a detail-oriented QA engineer.

The candidate will be reporting to VP of Quality Assurance and is responsible for the strategic development and management of QA operations to support CMC operations and clinical activities in compliance with FDA, ICH, EMA regulations, guidances, industry standards, and company policies.

Minimum of 5 years of experience in quality assurance and document control roles within the biopharmaceutical industry, with specific experience in CAR T manufacturing preferred. The Quality Assurance and Document Control Manager will be responsible for overseeing all quality assurance activities and document control processes to support CAR T GMP manufacturing and IND/Clinical phases.

Join our Quality team at a pioneering medical technology startup with FDA approval, where you'll be instrumental in advancing innovation and product excellence in medical robotics.

Fulfill the Development QA / Design Assurance role on Software Product Development Core and/or Design Change Teams as the design progresses through the development lifecycle. You will be part of the US Diagnostics Development Quality (Design Assurance) team and report to the Manager of Design Quality Assurance responsible for Diagnostic Software Development Quality.