Associate Director, Quality Assurance
Akebia TherapeuticsCambridge, MA, United Statesjob_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionLinkedIn
Twitter
Email
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. 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. 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. 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, a ll 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.
Associate Director, Quality Assurance
Message
Share
- var a2a_config = a2a_config || {};
- a2a_config.onclick = 1;
Quality Assurance
Cambridge, MA
ID : 25A-19
Full-Time / Regular
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).
Essential Functions & Duties
Skills & Experience
Basic Qualifications
Preferred Qualifications
Compensation
Targeted Base : $156,859 - $193,768
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
serp_jobs.job_alerts.create_a_job
Associate Quality Assurance • Cambridge, MA, United States
Job_description.internal_linking.related_jobs
A company is looking for a Clinical Quality Associate (Remote).Key Responsibilities Manage the clinical support inbox and respond to inquiries from internal teams, providers, and patients Interp...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Associate Director, Quality Assurance.The Early Development Quality Lead is responsible for the strategic quality oversight of internal and external (outsourced) activities in support of nonclinica...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden.For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Associate Director, Research & Development Quality.We are seeking a highly motivated and experienced Associate Director to join Research & Development Quality with a focus on vendor quality.The rol...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Associate Director, Clinical Quality Assurance.At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevat...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30 A company is looking for a Director, Quality Improvement HEDIS Operations.Key Responsibilities Lead and direct process improvement activities for HEDIS operations Collaborate with the Medicare S...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours 
Associate Director, Quality Assurance.Nearly 37 million Americans are currently affected by Chronic Kidney Disease.At Akebia we take that number very seriously and every day we come to work, with t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30 Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden.For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has help...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day Associate Director Regulatory Labeling .Nearly 37 million Americans are currently affected by Chronic Kidney Disease.At Akebia we take that number very seriously and every day we come to work, with...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30 A company is looking for an Associate Director, Biostatistics.Key Responsibilities Serve as a project statistician ensuring scientifically sound study designs and regulatory compliance Participa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30 A company is looking for an Associate Director of Consumer Policy.Key Responsibilities Drive consumer financial justice work by developing policy priorities and identifying opportunities for chan...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours 
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting.Base pay will be determined based on a number of factors including, but not limited to, ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Associate Director, Quality Assurance Gmp Training Mgmt.This role will provide Quality Assurance oversight for Training Management related to internal GMP operations at both the Gene Therapy Manufa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30 A company is looking for an Associate Director, Business Development to join their Business Development team.Key Responsibilities Identify and qualify business opportunities related to potential ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30 
US-RI-Providence | US-VA-Arlington | US-NC-Charlotte | US-GA-Atlanta | US-IL-Chicago | US-MA-Boston | US-PA-Philadelphia.
Quality Assurance / Quality Control.This role ensures that construction prac...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medic...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Asa Senior Associate, you may serve as the engagement lead on specific client accounts, taking responsibility for pre-engagement planning, execution and final deliverables.You will develop detailed...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
- serp_jobs.job_card.promoted
Licensed Clinical Quality Associate
VirtualVocationsLowell, Massachusetts, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Director, Clinical Quality Assurance
EisaiCambridge, MA, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Associate Director, Quality Assurance
Alnylam PharmaceuticalsCambridge, MA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Associate Director, GCP Clinical Quality Assurance
LantheusBedford, MA, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Associate Director, R&D Quality
ModernaCambridge, MA, USserp_jobs.job_card.permanent
- serp_jobs.job_card.promoted
Associate Director, Clinical Quality AssuranceWaltham, Massachusetts
Kailera Therapeutics, Inc.Waltham, MA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Director of Quality Improvement
VirtualVocationsDorchester, Massachusetts, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Associate Director, Quality Assurance
AkebiaCambridge, MA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Associate Director, Quality Control
LantheusNorth Billerica, MA, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Associate Director Regulatory Labeling
Akebia TherapeuticsCambridge, MA, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Biostatistics Associate Director
VirtualVocationsLowell, Massachusetts, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
- serp_jobs.job_card.new
Associate Director of Consumer Policy
VirtualVocationsLowell, Massachusetts, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Associate Director, Early Development Quality (R&D QA)
Alnylam PharmaceuticalsCambridge, MA, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Associate Director, Quality Assurance GMP Training Mgmt.
Ultragenyx PharmaceuticalBedford, MA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Associate Director of Business Development
VirtualVocationsLowell, Massachusetts, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Quality Director
Gilbane Building CompanyBoston, MA, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Executive Director, Quality Operations
ArdelyxWaltham, MA, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Assurance Senior Associate
Waldron H. Rand & Co.Dedham, MA, USserp_jobs.job_card.full_time