Director Quality Engineering
Company: Akebia Therapeutics, Inc.
Posted on: February 23, 2021
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
- 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
- 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
- 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
- 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
- Experience managing/leading teams or projects.-- Preferred
- Bachelor's degree in a scientific discipline or Engineering. An
advanced degree in a scientific discipline is strongly
- 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
- 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
- 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
- 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
- Ability to travel approximately 10% to various meetings
including overnight trips. Some international travel may be
- Must be able to adapt to other personalities in a respectful
manner that is conducive to goal achievement and team
- 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
Didn't find what you're looking for? Search again!