Director Quality Engineering

Company: Akebia Therapeutics, Inc.
Location: Cambridge
Posted on: February 23, 2021

Job Description:

The Director, Quality Engineering is responsible for the management and oversight of the Quality Assurance aspects of validation and qualification, including review and approval of validation and qualification documents related to Process, Cleaning, Equipment, Computer, change controls for Facilities and Utilities, in accordance with the Akebia Quality Management System (QMS) and Quality Policy requirements to ensure that products are manufactured at Akebia suppliers and contract manufacturing organizations (CMOs) 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 Vice President (VP) of Quality.-- The Director, Quality Engineering will develop strong relationships, collaborate, and interact with various departments (i.e., Quality Operations, Quality Systems, Technical Operations, Analytical Development, Regulatory Affairs, Pharmacovigilance, Procurement), and all levels of management at Akebia to accomplish company objectives. This individual will serve as a technical liaison between Akebia and its suppliers, providing Quality guidance and oversight of clinical and commercial drug substance and drug product continuous process verification (CPV) programs, GxP qualification and validation plans, protocols and controls, including review and approval of major manufacturing deviations. The incumbent is responsible for Quality Assurance guidance and oversight and effective management of the Akebia Validation Master Plan, process validation strategy, and all GxP-related qualification and validation activities occurring at all Akebia internal and supplier/contract manufacturing organizations and laboratories. The incumbent is accountable to lead, develop, and manage the Quality Assurance Validation team to maintain compliance, achieving company goals in a timely manner. The Director will lead a team of associates, which includes responsibility for scheduling and balancing of departmental workload, interviewing, hiring, training, developing and mentoring of subordinate employees. As appropriate, the Director will also provide QA approval of major/critical deviations related to qualification and validation activities. Required Skills

• Provide guidance, oversee, review and approve the Akebia Validation Master Plan (VMP), including GxP aspects of Akebia computer systems, facilities and utilities. Ensures Validation Master Plan is established at CMO/Suppliers.
• Ensures CMO/Suppliers have appropriate systems and documentation to perform validation activities as described in the established Quality Agreement.
• Provides guidance, reviews and approves CMO/Suppliers validation plan (or project plan), validation protocols and validation reports.
• Verifies validation pre-requisites are complete, process parameters, critical quality attributes, limits and acceptance criteria in the validation protocol are justified.
• Reviews and approves any changes to approved validation strategy, plan, protocol, or supporting stability study design.
• Verifies that conclusions drawn in the validation reports are appropriately supported and accurately reflect the validation protocols and study objectives.
• Reviews and approves deviations, investigations and findings associated with validation activities, verifying conclusions drawn in the validation reports are accurately reflected in approved corrective action/preventive actions (CAPAs).
• Ensures all reports have the technical merit and completeness according to regulatory expectations
• Ensures appropriate and timely communication and escalation of significant issues that may have regulatory compliance and/or commercial impact
• Provides quality oversight and guidance (including expectations and requirements) for continuous process verification (CPV) program, plans and protocols
• Reviews and approves CPV program-related documents, including statistical trends and reports
• Establish current and long-range plans and objectives required to assure operational and corporate compliance
• Analyze and drive improvement in performance through Quality Improvement Plans
• Support the preparation of annual product reviews (APRs) and relevant trending metrics
• Support supplier performance reviews, audits as required.
• Support the development, implementation, and continuous improvement of the supplier Quality Management Systems.
• Recommend actions relating to supplier qualification / de-qualification. Required Experience Basic Qualifications:
  • 8 years of experience in the Pharma/Biotech Industry
  • Minimum of 2-5 years of progressive responsibility in pharmaceutical/biotech, GxP related pharmaceutical Quality Assurance
  • Experience managing/leading teams or projects.-- Preferred Qualifications:
    • Bachelor's degree in a scientific discipline or Engineering. An advanced degree in a scientific discipline is strongly preferred.
    • Excellent in-depth, working knowledge of the applicable GMP operations and applicable GxP regulations and guidelines.
    • Excellent critical-thinking skills including troubleshooting problems, identifying solutions, recommending and implementing methods, procedures, and/or techniques and tools for resolution
    • Ability to demonstrate sound judgement and decision making
    • In-depth working knowledge of Quality processes related to operations, laboratories and/or supplier quality.
    • Proven ability to couple strong, technical process understanding with strong regulatory and compliance understanding to ensure that operations (including testing) are conducted in a complaint manner
    • Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success
    • Must professionally, clearly, concisely, and consistently communicate to external and internal customers.
    • Leadership: Must be able to lead, manage, and build a GxP exceptions management team in a fast-paced, growing environment.--
    • Must be able to prioritize work effectively to ensure the team can meet department and corporate goals and objectives.
    • Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct, and track deliverables and to communicate with internal and external team members.
    • Ability to travel approximately 10% 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 validation, change control, deviations, OOS, and CAPA management 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 www.akebia.com 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.

Keywords: Akebia Therapeutics, Inc., Cambridge , Director Quality Engineering, Engineering , Cambridge, Massachusetts