Join bluebird bio’s enthusiastic and collaborative Quality Assurance team and contribute to the overall success of our novel gene and cell therapy approach. This person will support the integrated GxP audit and the inspection management program. The successful candidate will be responsible for scheduling, organizing and follow-up of internal and external audits per the approved audit schedule and controlling the approved vendor list. Additionally, he/she will ensure audit observations are communicated, tracked and remediated in compliance with internal policies as well as with all applicable regulatory requirements. He/she will also be responsible for assisting in the preparation, coordination and hosting of audits and regulatory inspections
About the role:
- Schedule, conduct and follow-up on audits (GMP and GTP) in accordance, approved procedures and applicable standards and regulations.
- Responsible for tracking audits to the approved Audit Schedule.
- Assist with administration of contract auditors ensuring adherence to approved budgets.
- Maintain the Approved Vendor List (AVL) standards.
- Assist in company preparations for and conduct of regulatory inspections.
- Compile quality metrics related to audits for dissemination at Quality Council and Management Review.
- Monitor industry inspection trends, new/revised regulations and guidance for impact to bluebird bio operations.
- Recommends and implements improvements to the audit and inspection management programs based on new regulations, guidance documents, and industry standards
- Work cross functionally to provide compliance advice in the GMP realm
- Minimum of 8 years required with industry experience within GMP Quality Assurance
- Knowledge and application of GMP, GTP, GLP regulations in U.S. and EU, Q10 and other international regulatory requirements are necessary
- Cellular therapy experience a plus
- Ability to build relationships and influence across disciplines and all levels
- Strong commitment to clinical research and business ethics
- Highly motivated, flexible, and have excellent organizational and communication skills.
- Ability to prioritize and balance work from multiple projects in parallel.
- Ability to travel up to 25%.
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
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.