CMC Quality Assurance, Manager/Sr. Manager, growing group
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. We seek an experienced Quality Assurance professional to be responsible for managing global cGMP operations to support the development of bluebird bio products from early stage discovery through commercialization. You will be expected to represent the QA department on project teams and ensure regulatory compliance across bluebird bio development programs.
About the
position
:
Maintain bluebird bio QA program, policies, and procedures to ensure cGMP compliance of clinical trial material with internal and external standard operating procedures and applicable global regulations
Serve as bluebird bio QA contact between, partners, vendors, and contract facilities for Quality Assurance issues
Conduct QA review of manufacturing records, preclinical studies, clinical trial documentation and documents submitted to regulatory agencies
Disposition of Drug Product Clinical Trial Material for use in clinical trials
Support GMP readiness for transition to commercial production
Support internal quality systems, including document control, training, vendor management, audits and inspections, change control, deviations and investigations, and other GXP systems
About you:
10
years of biopharmaceutical experience with greater than 5 years experience in managing a QA function
BS in biology, chemistry or life science discipline
Strong knowledge of global cGMP practices and trends pertaining to pharmaceutical product development, manufacturing and testing
Experience in cell or gene therapy
Familiarity with global compliance and submission requirements and other regulatory agencies
Understand global regulatory agency policies and guidance as they pertain to QA issues
Exercises judgment within broadly defined practices and policies in determining solutions and actions
Demonstrates ability to identify and recognize critical decisions that will result in critical delays in schedule or operations and may jeopardize overall business activities
Demonstrates ability to change the thinking and/or gain acceptance of others in sensitive situations
Provide QA expertise/guidance across organization
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
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. We seek an experienced Quality Assurance professional to be responsible for managing global cGMP operations to support the development of bluebird bio products from early stage discovery through commercialization. You will be expected to represent the QA department on project teams and ensure regulatory compliance across bluebird bio development programs.
About the
position
:
Maintain bluebird bio QA program, policies, and procedures to ensure cGMP compliance of clinical trial material with internal and external standard operating procedures and applicable global regulations
Serve as bluebird bio QA contact between, partners, vendors, and contract facilities for Quality Assurance issues
Conduct QA review of manufacturing records, preclinical studies, clinical trial documentation and documents submitted to regulatory agencies
Disposition of Drug Product Clinical Trial Material for use in clinical trials
Support GMP readiness for transition to commercial production
Support internal quality systems, including document control, training, vendor management, audits and inspections, change control, deviations and investigations, and other GXP systems
About you:
10
years of biopharmaceutical experience with greater than 5 years experience in managing a QA function
BS in biology, chemistry or life science discipline
Strong knowledge of global cGMP practices and trends pertaining to pharmaceutical product development, manufacturing and testing
Experience in cell or gene therapy
Familiarity with global compliance and submission requirements and other regulatory agencies
Understand global regulatory agency policies and guidance as they pertain to QA issues
Exercises judgment within broadly defined practices and policies in determining solutions and actions
Demonstrates ability to identify and recognize critical decisions that will result in critical delays in schedule or operations and may jeopardize overall business activities
Demonstrates ability to change the thinking and/or gain acceptance of others in sensitive situations
Provide QA expertise/guidance across organization
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
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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