Job Description

Job Title: Senior Principal Specialist, Supplier Quality

Job Location: United States

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

Quality Assurance

Cambridge, MA

ID: 24A-22

Full-Time/Regular

THIS IS A REMOTE ROLE BASED ON THE EAST COAST

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

• Assist in the development of processes and procedures to ensure that a risk-based supplier management program is implemented and compliant with industry regulatory standards and requirements.
• Establish and monitor supplier performance to include metrics such as conformance to specifications, responsiveness to corrective action requests, and complaints.
• Oversee the review and approval of deviations and non-conformances.
• Monitor, analyze, and drive improvement in supplier performance through supplier performance improvement plans.
• Obtain and facilitate supplier Annual Product Quality Reviews (APQR’s) and Quality Management Review (QMR).
• Develop, implement, and maintain Supplier Corrective Action Request (SCAR) program to monitor supplier non-conformance performance, drive root-cause analyses, corrective actions and process improvements to reduce the Number of Defects and Cost of Quality
• Support the development, implementation, and continuous improvement of the supplier Quality Management Systems.
• Provide technical and quality knowledge for supplier selection, qualification, audits, and approval. Support proper selection of purchased product and suppliers for new products and life-cycle management of current product.
• Closely partner with the R&D and the Procurement teams to develop an approval process to qualify new suppliers/facilities. Recommend actions relating to supplier qualification / de-qualification.
• Maintain and approves Quality Agreement/Technical Agreements, ensuring adherence to established expectations.
• Plan and maintains an overall audit schedule for suppliers. Ability to facilitate and execute supplier audits including generating audit agenda’s and reports.
• Participates in the management of product transfer involving suppliers.
• Contributes to the development, maintenance and improvements of divisional supplier management policies, procedures, and quality agreements.
• Collaborate with Supply Chain on new supplier introduction and supply chain initiatives.

Basic Qualifications

• Bachelor’s degree in a scientific discipline is required. An advanced degree in a scientific discipline is strongly preferred.
• Minimum of 6-8 years of progressive responsibility in pharmaceutical/biotech, GxP related Quality environments, with 3-5 years in Supplier Quality or similar role.
• In-depth working knowledge of the applicable cGMP/GCP/GLP/GVP regulations and guidelines in a pharmaceutical environment.
• In-depth working knowledge of Quality processes related to operations and/or supplier quality.

Preferred Qualifications

• Communication Skills: Must professionally, clearly, concisely, and consistently communicate to external and internal customers.
• Leadership: Must be able to lead, manage, and build a GxP Supplier Quality program in a fast-paced, growing environment.
• Must be able to prioritize work effectively to meet department and corporate timelines.
• Must be able to efficiently utilize the computer hardware and software programs (including statistical software) provided to plan, manage, conduct, and track deliverables and to communicate with internal and external team members.
• Ability to travel approximately 25% to various meetings including overnight trips. Some international travel may be required.
• Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
• Pro-active in identifying opportunities along with strong problem solving and negotiation skills.
• Leads by example and highly collaborative with the proven ability to work in a cross-functional team.
• Thorough knowledge of and competence in core quality processes - including change control, deviations, OOS, CAPA management, and supplier complaints.

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:

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.

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