Join bluebird bio's enthusiastic and collaborative Global Quality Assurance Validation (QAV) team to contribute to the overall success of our novel gene therapy. This position will be the QA lead on cross-functional technology transfer projects and other development projects. Responsible for Quality oversight of internal process development, scale-up, process transfer to CMO or internal manufacturing site, clinical readiness and/or process validation (PPQ) and commercial readiness. In this position you will be responsible for guidance and technical review of process characterization deliverables, protocols and reports related to analytical test methods, technology transfers, process validation, and shipping validation activities. These activities will encompass IND-enabling, pre-clinical, clinical and commercial projects. The successful individual will own, lead or support multidisciplinary, multi-site, moderate to complex projects.
About the role:
QA lead on internal bbb and external CMO cross functional teams for development, technology transfer, and process validation projects.
Provide support and guidance in the development and execution of internal technical protocols, reports, and risk assessments.
Ensure contract manufacturing organizations are prepared for bluebird bio qualification audits and regulatory inspections.
Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
Ability to drive the implementation of new policies and procedures to support bbb quality systems.
Ability to multitask and prioritize independently in a high paced environment.
Thorough knowledge and understanding of FDA and foreign requirements and expectations.
QA Approval of change controls and validation documents e.g. Impact Assessment, Risk Assessment, Protocols and Reports.
Represent the Global Quality Assurance Validation group in project teams, audits and inspections as required.
Support the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
Support the development of long-range goals and objectives.
Exercise considerable latitude in determining objectives and approaches to critical assignments.
In-depth breadth of expertise in product lifecycle, process validation, analytical methods, computer systems, tech transfers, shipping validation and broad knowledge of related functions developed from considerable work experience.
Bachelors' and/or Masters' degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
A minimum of ten (10) years of experience in the industry, ideally all clinical phases through commercial drug product.
Knowledge of cGMP guidelines, ICH and other international regulatory requirements relevant to process development, scale-up and validation.
Leadership skills to lead cross functional teams to ensure project success.
Capability to effectively manage 1 or more individual contributors.
Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
Ability to travel approximately 25%
Ability to build authentic relationships with contract manufacturers.
Experience using risk based approaches (FMEA, PHA, etc).
Project management experience.
Strong analytical ability.
Experience supporting internal regulatory and partner inspections.
Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise with little or no supervision.
Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.
Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
Bluebird Bio, Inc.