Senior Director Quality Assurance GMP (Elkton)


  • Industry: Executive Management - Engineering/Production
  • Type: Full Time
position filled

Akebia is seeking an experienced Quality leader to join the Quality Operations team. The Sr. Director of GMP Quality Operations will lead a team of Quality professionals and will play a lead role in managing QA oversight of Contract Manufacturing and Contract Testing Organizations for production, validation, testing, and disposition of commercial product and investigative drugs for use in clinical trials. The Sr. Director, GMP Quality Operations will work closely with the other functional Quality areas and CMC teams and will be responsible for quality oversight of contract manufacturing operations (CMOs).

Required Skills

  • Quality oversight of contract manufacturing operations of drug substance and drug product for commercial and clinical trial materials.
  • Responsible to ensure adherence to applicable regulations and company procedures for commercial and clinical trial material.
  • Responsible for material disposition of commercial product and clinical trial materials to support clinical trials including generation of Certificate of Analysis.
  • Oversee and monitor Quality Assurance processes with focus on master production and control records to ensure that production and control operations are adequately defined and that good manufacturing practices are utilized for the manufacture of drug substance and drug product at CMOs for commercial and clinical supplies.
  • Development, review, and approval of the Validation method and process Master Plan and Validation Protocols, executed protocols, and summary reports at both Akebia and CMOs.
  • Oversees and/or Performs assessments and QA approval of deviation and investigations including OOS investigations for commercial and clinical products
  • Participate and/or Conduct Risk Assessment and / or Failure Mode and Effects Analysis (FMEA) activities for both Design and Process FMEA's
  • Define and implement, as appropriate, quality standards, systems, and metrics for GMP Quality operations.
  • Compile, organize, analyze and present GMP Quality metrics identifying risk factors and risk mitigations to Senior Management
  • Participate in preparation for and execution of regulatory inspections. Ensure observations are addressed appropriately and completed as required and on time.
  • Ensure internal compliance to 21 CFR Part 11 and relevant global computerized system regulations for document management and related GxP computerized systems.
  • Manage review of product release and stability data, develop and support process and method tech transfers and validations.
  • Manage and review of GMP supplier audits as applicable.
  • Lead quality aspects of and provide quality support on tech transfers and GMP and/or related investigations.
  • Ensure Quality Management Reviews and periodic product reviews
  • Key participant in Material Review Board (MRB) including review and recommendation for material disposition and corrective actions.
  • Responsible for managing and developing staff in order to accomplish agreed upon Goals and Objectives for the functional area.
  • Other duties as assigned such as Quality representative on project management teams.

Required Experience

Basic Qualifications:

  • BA/BS
  • 15+ years of experience in the pharmaceutical or biopharmaceutical industry, min 10 years experience in a Quality function (QA) with increasing levels of responsibility
  • Supervisory experience

Preferred Qualifications:

  • BA/BS in Chemistry or life sciences (Biology, Pharmacology, etc.), or Chemical Engineering
  • Experience with solid oral dosage forms.
  • Thorough understanding of quality operations and practices in a pharmaceutical commercial and clinical supply environment. Experienced with oversight and management of CMO relationships
  • Experience in managing and identifying continuous improvement opportunities for cGMP quality systems, including validation, Material disposition, Certificates of Analysis, Stability monitoring and Specifications. Expert knowledge of FDA, EU, ICH, ISO requirements for GMP and related areas
  • Ability to lead and work with others, including CMOs
  • Demonstrated complex problem-solving ability and demonstrated sound judgement.
  • Demonstrated ability to work in a multi-disciplinary setting acting as facilitator
  • Strong leadership, team building, organizational, communication and interpersonal skills
  • Ability to travel approximately 25%

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at .

Akebia Therapeutics 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.

Associated topics: automation, performance test, process, prevent, prevention, quality assurance, quality assurance engineer, software quality, software quality assurance engineer, test

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