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 Associate Director, Quality Assurance is responsible for the oversight, execution, and maintenance of the Quality Product Complaint Program for all Akebia Therapeutic Inc. (Akebia) commercial products. The incumbent’s primary responsibilities include, but are not limited to the receipt, initiation, investigation, escalation, timely completion, trending, and KPI reporting of complaints for Akebia products in collaboration with Akebia’s colleagues, partners, and CMOs for finished, commercial products manufactured by or on behalf of Akebia. The incumbent will also assure that the commercial Quality Product Complaint Program is in compliance with regulatory guidelines and expectations for all marketed territories.
The scope of this role will include the oversight, management and trending of Akebia’s Deviation, Change Control and CAPA programs, assuring that activities are conducted in accordance with GxP guidelines, applicable global regulations, and company policies and procedures. Responsibilities will include supporting the Akebia Supplier Quality and GxP audit programs, as applicable, as well at the development, maintenance and continuous improvement of Akebia’s Quality Management System (QMS).

SKILLS & EXPERIENCE

Basic Qualifications

• Bachelor’s degree in a scientific discipline or Engineering is required. An advanced degree in a scientific discipline is strongly preferred.
• 8+ years of experience in the pharmaceutical industry
• Excellent written and oral communication skills required with ability to draft, review, and approve technical reports.

Preferred Qualifications

• MS Preferred
• Audit and compliance experience
• Recognized as an expert resource on a range of GXP compliance topics.
• Strong verbal and written communication skills and interpersonal skills.
• Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
• Excellent organization skills and project management.
• Able to work equally well as part of a team or independently
• Ability to travel approximately up to 25% required.

• Ownership of Standard Operating Procedures (SOPs) related to Quality Product Complaints and interfacing programs for clinical and commercial complaints. Ensure that all SOPs are compliant with FDA’s current Good Manufacturing Practices.
• Responsible for the management and oversight of all commercial Quality product complaints. This includes but is not limited to the investigation, follow-up, review and approval of product complaints and associated manufacturing investigations to ensure completeness and accuracy.
• Troubleshoot and escalate product complaints, as appropriate,
• Responsible for supporting the processes involving defective products and for participation in the filing of Field Alert Reports and execution of recalls as required by the company and FDA or other regulatory agencies as necessary.
• Maintain systems to track and trend key quality system indicators. Ensure monthly KPIs are issued on time and any deficiencies noted are promptly addressed.
• Collaborate cross-functionally and interact with internal customers, partners and CMOs to accomplish company objectives and team goals including, but not limited to product complaint and adverse event investigations, FARs, and recalls.
• Monitor and report on new compliance initiatives and regulations from Regulatory authorities related to product complaints, deviations, change controls and/or CAPAs, as applicable.
• Monitor industry and Akebia inspection trends, new/revised regulations regarding product quality complaints, deviations, change controls, CAPAs, trending, and/or guidance for impact to the Quality organization.
• Represent QA on teams and related working groups and Quality governance forums, as appropriate.
• Investigate and facilitate reporting of critical compliance issues.
• Support CAPA plan development and perform effectiveness checks of CAPAs as required.
• Support regulatory agency inspections, as needed.
• Foster a commitment to quality in individuals and a culture of quality within the organization.
• Support the Supplier Quality and inspection programs with respect to compliance input and identified trends.
• Provide Quality & compliance input related to new and often complex Quality/QMS processes.
• Ensure adherence to departmental SOPs
• Lead intra or interdepartmental teams of an operational nature such as preparing Akebia for minor changes in regulations, continuous improvement initiatives etc.
• Reviews and approves deviations, investigations and findings, verifying conclusions drawn are accurately reflected in approved corrective action/preventive actions (CAPAs)
• Support the preparation of annual product reviews (APRs) and relevant trending metrics.
• Support the Akebia CPV program by providing relevant input and trending metrics.