Manager of Design and Quality Assurance

Company Background

Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with NASH, a disease for which there are currently no marketed therapies.

We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.

Job Summary

The Manager of Design and Quality Assurance will be a key member of the Development team with primary responsibility for the design assurance and risk management requirements for the device constituent of Akero’s Combination product. This position is remote within the United States. The successful candidate will be responsible for managing all QA functions that include but are not limited to: Design Assurance and Controls (e.g., Development Planning, Design Inputs, Design Outputs, Design Verification, and Design Validation), Risk Management File, DHF Management, Statistical Sampling Plans, oversight of Assembling and Secondary Packaging providers, and Device Product Complaints. The Manager of Design and Quality Assurance is tasked with defining and promoting a device quality mindset across the entire company and its critical suppliers.

Job Responsibilities

• Serves as lead for Design Control requirements in accordance with 21 CFR 820 and ISO 13485.
• Assures quality products and processes by establishing and enforcing quality and risk management standards within the Quality Management System.
• Creates product quality documentation system by writing and updating quality assurance procedures to conform to company and industry requirements.
• Management the implementation, maintenance, and improvement of Design Controls and Risk Management based on established company direction, development phase, and priorities.
• Leads, supports and performs activities in the following areas: Supplier Audit of Assembly and Secondary Packaging vendors, CAPA, Deviations, Complaints, and Risk Management.
• Lead the quality team by hiring, managing, and developing staff to support Akero’s Quality System.
• Provides leadership to Product Development teams by ensuring Design Assurance through the Design control processes.
• Ensure Design History Files are established in accordance with company procedures, 21 CFR 820, and ISO 13485 requirements.
• Compiles and reports key performance indicators, metrics and compliance status of Design Assurance and Risk for Management Review and Executive staff.
• Establishes and maintains continuous improvement programs.
• Ensures compliance to quality policies, procedures, and governing regulations.
  
  
  

Qualifications

• A minimum of 10 years of device design and development or Quality Management System experience in a pharmaceutical, medical device, or related industry.
• Ability to effectively collaborate with colleagues and interface with suppliers.
• Excellent analytical abilities, strong communication skills, and effective attention to detail.
• Strong leadership and interpersonal skills.
• Versed at developing metrics and implementing actions that make improvements in those metrics.
• Ability to work independently and in a group on a variety of projects.
• Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.
• Ability to monitor and report on assigned tasks, goals, and company objectives.
• Proficiency in Microsoft Office (Word, Power Point, Excel, Outlook, etc.)
  
  
  

Educational Requirements

• Bachelor’s degree in product design, quality engineering, chemistry, or a related scientific discipline.
  
  
  

Compensation

• Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas.
  
  
  

Pay range: $135,000 - $165,000 per annum