ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
Join bluebird bio’s enthusiastic and collaborative Quality Services & Compliance team to contribute to the overall success of our novel gene therapy approach. We seek an experienced Quality professional to join our North Carolina manufacturing facility. The Senior Manager, Quality Assurance Validation will lead the QAV department ensuring conformance to established quality processes and standards while actively working to continuously improve them. This role is responsible for site Quality Validation and serves as a people manager the department as bluebird starts up its bRT facility, creating an energized, efficient, and effective team.
HOW YOU’LL FLY
- Has in-depth or 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.
- Leads team/Workstream through navigating complex problems that have a broad impact on the business and successfully drives solutions to such things as quality systems, audits, inspections, change controls, and validation documents.
- Proven ability to effectively lead team/Workstream with a meaningful impact on critical goals.
- Accountable for the performance and results of a Quality Validation area or Workstream with a broad impact on the organization.
- Participates in setting the Quality Validation strategy.
- Owns the bRT Site Validation Master Plan.
- Provides QA support for validation activities including: o Technology Transfer o Process Validation o Analytical instrument qualification, use and maintenance o Computer systems validation o Equipment and Facilities commissioning, qualification, use and maintenance o Cleaning validation
- Provides guidance, review and approval of internal validation documents including validation plans, requirement documents (URS, FS, CS), protocols, data analysis, and final reports.
- Drives the implementation of new policies and procedures to support bbb quality systems.
- Exercises judgment within and outside of defined procedures and practices to determine appropriate action.
- Sound 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.
- QA Approval of change controls and validation documents e.g. Impact Assessment, Risk Assessment, Protocol, Report, and User Requirements.
- Represents the Quality Assurance Validation group in project teams, audits and inspections as required.
- Supports the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
- Supports the development of long-range goals and objectives.
- Exercises considerable latitude in determining objectives and approaches to critical assignments.
WHAT YOU’LL BRING
Wide range of expertise or working knowledge across validation disciplines outlined above.
- Expertise in support of Technology Transfer initiatives.
- Bachelors’ and/or Masters’ degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
- A minimum of 10 (10) 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.
- Personnel 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.
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.