THIS IS A HYBRID ROLE BASED OUT OF OUR CAMBRIDGE MA OFFICE
Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.
At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.
This is life-changing work, and we are all in, are you?
This Supplier Quality role is a strategic leadership role responsible for the management and oversight of Akebia suppliers and contract manufacturing organizations (CMOs) in line with the Akebia Quality Management System (QMS) and Quality Policy requirements to ensure that products are manufactured in a manner compliant with industry and regulatory standards. This position will be a member of the Quality Leadership Team and will report to the Senior Director, Quality Operations and Engineering.
This role will develop strong relationships, collaborate, and interact with various departments (i.e., Quality Operations, Quality Systems, Chemistry Manufacturing, and Controls (CMC), Analytical, Regulatory Affairs, Pharmacovigilance, Procurement), and all levels of management at Akebia to accomplish company objectives. This individual will serve as a critical liaison between Akebia and its suppliers, providing product Quality oversight, maintaining required supplier controls, generating supplier quality data, trends, metrics, audits, and related reports and determining/monitoring the effectiveness of supplier corrective and preventive actions to resolve non-conforming issues.
The incumbent is responsible for overseeing the Quality and effectiveness of Akebia supplier and contract manufacturing organizations and is accountable to lead, develop, and manage the Supplier Quality system to achieve company goals in a timely manner.
The Senior Principal Supplier Quality Specialist will:
Basic Qualifications:
Preferred Qualifications:
Compensation:
Targeted Base: 153,406 - 189,501*
*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company’s total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.
Are you an Akebian?
An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian’s aren’t afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian’s believe that we are better together because we are all working toward a common purpose – to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com
COVID 19 Vaccination: All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship. Please note that it is unlikely that accommodations can be granted for customer-facing positions.
Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
Required Skills
Required Experience
Skills and Abilities
Education/Experience
Associate degree in Drafting or Engineering required; Bachelor’s degree preferred
Experience using AutoCAD required; experience using other Autodesk programs, including, but not limited to, Revit and Civil 3D preferred.
Experience with SolidWorks is desirable
Knowledge of design techniques, tools, and principles involved in the production of precision technical plans, blueprints, drawing, and models
Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications
Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services
Knowledge of materials, methods, and the tools involved in the construction or repair of structures such as bridges and tunnels
Knowledge of the use of Finite Element Analysis (FEA) in conjunction with 3D solid modeling preferred
Knowledge of symbols and standards related to drafting machine components (clearances, tolerances, surface roughness, etc.)
Physical Demands
Traylor Bros., Inc. is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, veteran status, sex, sexual orientation, gender identity, age, genetic information, pregnancy, disability, protected activity, or other non-merit factors.