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Sr. Manager Quality Control

Boston, MA
Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company focused on developing gene therapies with the potential to restore, improve and preserve high-acuity physiologic hearing for people worldwide who live with disabling hearing loss.
 
Restoring, improving and preserving high-acuity hearing is an area of high unmet need in medicine: 466 million people worldwide have disabling hearing loss, and there are no FDA-approved therapies to address its underlying causes.
 
Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.  Listening is in our DNA. We believe the only way to achieve our ambitious goals is to engage as one team, listen to each other, and trust in ourselves and our science.

Job Summary:

The Technical Operations group is seeking a Quality Control professional to lead a cGMP-compliant quality control function. This individual will start-up and manage the GMP-related quality control function, manage staffing resources, scheduling and implementation of processes and procedures necessary to successfully manufacture viral vector drug products to support human clinical trials and eventually commercial manufacturing.  

Job Responsibilities:

•    Assess the requirements of Good Manufacturing Practice as related to quality control for GMP cleanroom facility environmental monitoring support and quality control testing of drug products to be used in human therapeutics 
•    Development and tracking of performance metrics for site quality control activities
•    Proactively promote a positive safety and quality culture and sound GMP operating principles
•    Develop the full spectrum of operations for quality control at Akouos
•    Ability to develop and effectively manage quality control monitoring and testing schedules for standard operations as well as during drug product cleanroom campaigns
•    Ensure requirements for environmental and testing of drug product and intermediates are applied appropriately to product needs related to pre-clinical studies, human clinical trials and commercial production  
•    Self-motivated, with a desire to succeed at the highest level 
•    Experience in building teams and managing direct reports
•    Work with cross-functional teams to develop therapies with the potential to restore, improve, and preserve hearing
•    Assist the Executive Leadership Team in establishing strategic directions for quality control resources and activities
•    Coordinate and collaborate with other groups to ensure that the quality control needs of Akouos are met 
 
Job Qualifications:
 
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

•    10+ years experience in the GMP manufacture of viral vectors or related biological cGMP manufacturing operations related to human therapeutic products
•    Thorough knowledge and broad experience in cGMP principles and requirements
•    Motivated self-starter who excels at time and people management  to deliver high quality work on time and within budget
•    Proven track record of leading a team in making GMP compliant products
•    Demonstrated leadership skills and experience in managing a GMP quality control staff including: mentoring team members, developing technical skills and providing leadership to the group
•    Knowledge and broad experience in aseptic processing, cleaning, materials and personnel flows, gowning requirements and cleanroom operations as related to GMP manufacture of products intended for human clinical use
•    Experience in GMP and Quality Management Systems requirements including but not limited to change control, deviations, investigations, CAPA, product and materials disposition, product testing, line clearances procedures and other processes and procedures needed in a GMP-compliant environment 
•    Strong background and experience in CMC requirements to support regulatory filings related to GMP manufacturing of drug products and operation of GMP-compliant manufacturing facilities
•    Demonstrated experience and successful track record in working in cross-functional teams to manage quality control needs in a GMP manufacturing environment
•    Experience in GMP cleanroom design, construction, start up, commissioning, qualification and validation including cleaning validation
•    Extensive experience in working in a cleanroom environment and the requirements necessary to operate in a GMP-compliant fashion and to properly monitor the environment to ensure compliance 
•    Experience working within a GMP-compliance team to ensure proper maintenance, calibration and service of GMP equipment as related to quality control
•    Demonstrated experience in working with suppliers and in negotiating supply chain pricing, tech transfer requirements and other deliverables necessary to meet timelines 
•    Proven track record in developing GMP-compliant controlled documentation such as SOPs, policies, test records, monitoring records, specifications, equipment logs and other types of documentation required for GMP compliance
•    Experience managing tracking and trending of QC data related to both environmental monitoring data and test results
•    Prior experience in generating user requirement specifications as well as identification, selection, purchasing and qualification of quality control equipment
•    Experience with vendor selection and qualification for external services and equipment 
•    Previous experience in supply management and tracking to ensure materials availability for the quality control group
•    Development of a strategy and successful implementation of quality control assay method technology transfer in a GMP environment
•    Track record of working in materials risk assessment, scoring and critical materials assessment, process failure modes and effects analysis, process monitoring and critical parameter metrics and database maintenance
•    Personal experience in an aseptic processing cleanroom environment and training staff to work in a cleanroom environment to consistently meet gowning, aseptic processing and cleanroom standards  
•    Experience in regulatory strategy and tactics related to GMP products and in generating CMC supporting documentation information required to support regulatory filings in the US is required.  
•    International regulatory CMC knowledge and experience is a plus 
•    Effective oral and written communication skills
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