Manager, Quality Systems, growing group, gene therapy
Company Name:
bluebird bio
Join our growing Quality group
bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio's product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinical options. bluebird bio has two clinical stage product candidates in development, one for childhood cerebral adrenoleukodystrophy (CCALD) and one for beta-thalassemia major/sickle cell disease, and an early stage oncology program in partnership with Celgene Corporation.
Join bluebird bio's enthusiastic and collaborative Quality team by contributing to the overall success of our novel gene therapy approach. This Quality Systems
manager
will oversee our GxP compliance programs. In this
position
, you will be responsible for leading the corporate Quality Management System in support of product quality and quality system compliance for a menu of bluebird staged clinical trial material through commercialization. Additionally, you will help develop and will maintain the bluebird bio Quality System consistent with international regulations. This is a great opportunity to have a major impact on developing the quality function and quality culture at bluebird bio.
About the position:
Maintain corporate Quality Management Systems in a state of compliance with current GxP regulations
Design, maintain, and monitor Corporate QA Metrics Program to track the performance of operations and quality systems
Manage GxP Documentation Program
Maintain the Corporate Training Program
Responsible for managing and coordinating the internal audit program as well as the external audit program consisting of supplier and/or contract manufacturing organization audits
Manage the efficient closing of Corrective Actions and related status
Manage problems of diverse scope using a high degree of personal judgment, and must be able to effectively represent bluebird bio Quality to local, corporate, and regulatory agencies
About you:
BA/BS and minimum of 7
years experience in a Quality Assurance/Quality Systems position
Experience with FDA inspections as well as strong understanding of disposition, investigations,
computer
, process and analytical qualification and validation, and change controls
Strong knowledge GxP regulations, quality systems and guidance documents
Experience with implementing and validating electronic documentation system strongly desired. Understanding of 21CRFPart11 requirements
Outstanding written and verbal skills as well as problem solving skills
Demonstrated team player with experience contributing to multi-disciplinary project teams and ability to work with minimal supervision
Strong initiative and ability to assume significant project management skills
Must have excellent attention to detail and time management skills as well as the ability to manage multiple priorities with aggressive timelines
The ideal candidate is self-motivated, and directed; works independently as well as in a team environment
Ability to work with minimal supervision and be capable of effectively working in a matrix-based organization
You will interact with a broad range of contacts (e.g., Manufacturing, Supply Chain, Quality Assurance, Quality Control, Materials Management, and Regulatory Affairs) and requires strong interpersonal skills
Independently motivated, detail oriented and good problem solving ability
Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
Excellent communication skills and ability to influence across multiple functions
Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular. bluebird bio is a publicly traded company on the NASDAQ Global Select Market and trades under the symbol BLUE. We were named to the 2012 FierceBiotech Fierce 15. We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.
bluebird bio, 150 Second Street, Cambridge, MA 02141 www.bluebirdbio.com
bluebird bio will only accept
job
applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.
Estimated Salary: $20 to $28 per hour based on qualifications.
bluebird bio
Join our growing Quality group
bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio's product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinical options. bluebird bio has two clinical stage product candidates in development, one for childhood cerebral adrenoleukodystrophy (CCALD) and one for beta-thalassemia major/sickle cell disease, and an early stage oncology program in partnership with Celgene Corporation.
Join bluebird bio's enthusiastic and collaborative Quality team by contributing to the overall success of our novel gene therapy approach. This Quality Systems
manager
will oversee our GxP compliance programs. In this
position
, you will be responsible for leading the corporate Quality Management System in support of product quality and quality system compliance for a menu of bluebird staged clinical trial material through commercialization. Additionally, you will help develop and will maintain the bluebird bio Quality System consistent with international regulations. This is a great opportunity to have a major impact on developing the quality function and quality culture at bluebird bio.
About the position:
Maintain corporate Quality Management Systems in a state of compliance with current GxP regulations
Design, maintain, and monitor Corporate QA Metrics Program to track the performance of operations and quality systems
Manage GxP Documentation Program
Maintain the Corporate Training Program
Responsible for managing and coordinating the internal audit program as well as the external audit program consisting of supplier and/or contract manufacturing organization audits
Manage the efficient closing of Corrective Actions and related status
Manage problems of diverse scope using a high degree of personal judgment, and must be able to effectively represent bluebird bio Quality to local, corporate, and regulatory agencies
About you:
BA/BS and minimum of 7
years experience in a Quality Assurance/Quality Systems position
Experience with FDA inspections as well as strong understanding of disposition, investigations,
computer
, process and analytical qualification and validation, and change controls
Strong knowledge GxP regulations, quality systems and guidance documents
Experience with implementing and validating electronic documentation system strongly desired. Understanding of 21CRFPart11 requirements
Outstanding written and verbal skills as well as problem solving skills
Demonstrated team player with experience contributing to multi-disciplinary project teams and ability to work with minimal supervision
Strong initiative and ability to assume significant project management skills
Must have excellent attention to detail and time management skills as well as the ability to manage multiple priorities with aggressive timelines
The ideal candidate is self-motivated, and directed; works independently as well as in a team environment
Ability to work with minimal supervision and be capable of effectively working in a matrix-based organization
You will interact with a broad range of contacts (e.g., Manufacturing, Supply Chain, Quality Assurance, Quality Control, Materials Management, and Regulatory Affairs) and requires strong interpersonal skills
Independently motivated, detail oriented and good problem solving ability
Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
Excellent communication skills and ability to influence across multiple functions
Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular. bluebird bio is a publicly traded company on the NASDAQ Global Select Market and trades under the symbol BLUE. We were named to the 2012 FierceBiotech Fierce 15. We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.
bluebird bio, 150 Second Street, Cambridge, MA 02141 www.bluebirdbio.com
bluebird bio will only accept
job
applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.
Estimated Salary: $20 to $28 per hour based on qualifications.
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