The Manager, Quality Systems is responsible for the development, management, and continuous improvement of Quality Systems at Akebia Therapeutics as it relates to Document Control, Quality Management System (QMS), and Training to ensure its products and processes are compliant to regulatory, functional area and business partner or customer requirements. Partner with all areas of the business to understand and address their needs/issues. Interface with all areas of the business to elevate potential issues to management and drive continuous improvement efforts. Provide expertise and leadership in implementing and managing a quality system management function for clinical and commercial products.

Essential Functions and Duties

Provide expertise on implementation and maintenance of a Quality Management System (QMS), including but not limited to document control, training, change management, and quality event management. Provide guidance and support for computer system validation plans and summaries in accordance with SDLC and Part 11/Annex 11 and review/approve all computer system validation deliverables. Support and sometimes facilitate continuous improvement initiatives designed to increase efficiencies. Support as subject matter expert for regulatory and partner audits. Partner with functional teams to identify and implement optimized system designs Manage process improvements for Quality Systems. Actively influence and participate on Quality initiatives from a strategic perspective. Direct, manage, provide guidance, and develop staff. Support the GxP training strategy for employees by developing, administering, and maintaining the overall training program. Develop and deliver training in various modalities. Collaborate with department heads to ensure training is effective and in compliance with all regulatory and technical requirements. Generate and facilitate changes to SOPs, policies, training materials, and other documents to ensure compliance and continuous improvement. Maintaining Document Control processes and systems. Provide end-user training and support for document management system and related processes. Prepare and analyze metrics for management review and escalation of issues.

Basic Qualifications

Bachelor’s Degree in scientific discipline 5+ years of quality assurance related experience.in Pharmaceutical, Biotechnology, or related industry in a quality role Leadership, management, or supervisor experience Computer system validation experience

Preferred Qualifications

Proficient in Microsoft Word, including document formatting, application of styles and numbering, tracked changes and comments. Comprehensive knowledge of good documentation practices Extensive knowledge and understanding of global requirements for cGxP and quality systems for clinical and commercial and ability to apply said knowledge to sound quality decisions. Robust working knowledge of software solutions for QMS. Demonstrated ability to coordinate process improvement initiatives and quality system related projects. Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, auditors, contractors, and consultants. Admin experience with Veeva QMS a plus

Compensation:

Targeted Base: $118,274 - 146,103*

*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.