Lead Specialist, Quality Assurance Validation- NC
Join bluebird bio's enthusiastic and collaborative Quality Assurance Validation (QAV) team by contributing to the overall success of our novel gene therapy. The focus of this position will support the organization through the establishment of bluebird bio validation/qualification programs across disciplines and ensure alignment with regulatory requirements and industry standards in accordance with the relevant product's lifecycle. In this position you will be responsible for guidance and technical review of protocols and reports related to test methods, facilities, equipment, computer systems, technology transfers, cleaning, process validation, cold chain storage and shipping validation activities. These activities will encompass technology transfer and commercial projects. The successful individual will own, lead or support multidisciplinary, multi-site, moderate to complex projects.
About the role:
About the role:
- Provide QA support, input and oversight for the internal QC testing laboratory and manufacturing site
- Provide QA support for validation activities including:
- Process Validation
- Analytical instrument qualification, use and maintenance
- Computer systems validation
- Equipment and Facilities commissioning, qualification, use and maintenance
- Cleaning validation (SIP and CIP)
- Provide guidance, review and approval of internal validation documents including validation plans, requirement documents (URS, FS, CS), protocols, data analysis, and final reports.
- Development of Validation Plans and Validation Plan Summary Reports.
- Ability to drive the implementation of new policies and procedures to support bbb quality systems.
- Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
- Ability to multitask, manage timelines and prioritize independently in a high paced environment.
- Thorough knowledge and understanding of FDA and foreign requirements and expectations.
- Works closely with all site functional teams (Manufacturing, Facilities, QC, etc) responsible for protocol development and execution to provide QAV support.
- Provide support of bluebird bio internal QC lab along with assay/method development.
- QA Approval of change controls and validation documents e.g. Impact Assessment, Risk Assessment, Protocol, Report, and User Requirements.
- Represent the 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.
- Wide range of expertise or working knowledge across validation disciplines outlined above.
- Expertise in support of Tech Transfer initiatives.
- Bachelors' and/or Masters' degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
- A minimum of eight (8) years of experience in the industry, ideally all clinical phases through commercial drug product.
- Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process, cleaning and equipment validation.
- Knowledgeable of Data Integrity requirements.
- Leadership skills to lead cross functional teams to ensure project success.
- Excellent written and verbal communication skills including the ability to communicate, influence and negotiate across the organization.
- Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
- Ability to travel approximately 5-10% based on project demand.
- Experience within a multi-product facility is a plus
- 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 situation 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