Senior Manager, QA Operations and Lot Disposition

Quality Assurance

Cambridge, MA

ID: 26A-02

Full-Time/Regular

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?

Job Summary

The Quality Senior Manager is responsible for oversight and management of Akebia’s global manufacturing network for all stages of a growing clinical and commercial pipeline. The incumbent will be responsible for the review of manufacturing and analytical records

to support disposition of both clinical and commercial drug substance (DS), drug product (DP) and Finished Goods (FG). Additionally, the incumbent will be responsible for the management and oversight of related Quality records such as deviations, change controls, and CAPAs arising from activities associated with Akebia’s manufacturing network for both clinical and commercial products. The Sr. Manager, QA Operations and Lot Disposition will help to build a strong, high-performing Quality Culture in a fast-paced, growing Quality organization.

Essential Functions & Duties

• Responsible for the oversight and execution of Quality disposition process for commercial and clinical products manufactured at CMOs ensuring products are released in accordance with Registered Approvals or Marketing Authorizations, their Manufacturing Authorizations, Clients Global Quality Standards and Procedures, and current Good Manufacturing Practice guidelines
• Perform and manage the QA review and approval of Master Batch Records and executed batch records.
• Manage the QA review and approval of analytical testing as part of the batch record review process.
• Perform disposition of drug substance batches and drug product lots
• Ensure accuracy of data used in Quality databases.
• Provide and report metric information associated with the disposition of materials
• Identify, initiate, and implement process and system improvements.
• Perform and manage the QA assessment/review/approval for deviations, change controls, and CAPA workflows.
• Lead the QA communication process with CMO quality partners to address observations and/or quality concerns.
• Participate in Regulatory and partner inspections as subject matter expert
• Create/revise SOPs or other documents and provide training, as required.
• Perform other QA related duties and ad hoc projects, as required.
  
  

Skills & Experience

Basic Qualifications

• Bachelor’s Degree
• 7 years of in the biotechnology or pharmaceutical industry
• 5 years in Quality Assurance with experience in both paper and electronic based systems including 21 CFR Part 11 compliance
• 5 years experience in pharmaceutical batch record review and product disposition
  
  

Preferred Qualifications

• Bachelor’s Degree in Chemistry, Biology, Life Sciences
• Experience working with global CMOs
• Experience in Maintaining a Quality infrastructure in a fast-paced growing company
• Strong verbal and written communication skills and interpersonal skills.
• Able to work equally well as part of a team or independently
• Experience in dealing with both US and EU Quality requirements with an understanding of a broad spectrum of QA GMP requirements.
• Technical writing skills.
• Critical thinking and problem-solving skills
• Proficient in Microsoft Office suite.
• Organization skills and project management.
• Direct experience in supervisory role
  
  

Compensation

Targeted Base:$155,00 - $191,471*

• 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

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 characteristics protected by applicable law.