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.
Computer Systems Quality Assurance Validation (CS QAV) (Contract)
This role is for a 6-month contract position.
ABOUT THE FLOCK
The Quality Assurance flock is all about getting stuff done and working collaboratively. Whether it’s making sure we’re supporting and enabling our customers to create and maintain compliant and purposeful processes, documents, and records in a quality system that supports the global organization, working collaboratively across the nest, or driving innovation as a unit, we are driven by effective communication, critical thinking, and the ability to ask questions while supporting one another. Come work with an energetic and enthusiastic group of birds that loves rising to the challenge much as we do!
HOW YOU’LL FLY
This position will support the organization through the establishment of bluebird bio validation/qualification programs across disciplines and ensure alignment with industry standards in accordance with the relevant product’s lifecycle. In this position, you will be responsible for guidance and quality review/approval of internal protocols and reports related to Computerized Systems and Data Integrity. These activities will encompass IND-enabling, pre-clinical, clinical and commercial projects. The successful individual will own, lead or support multidisciplinary, multi-site, complex projects.
As a Computer Systems Quality Assurance Validation bird reporting to Associate Director, Quality Assurance Validation, you'll help to bring more patients their bluebird days by:
- Provide QA support, attend team meetings, provide input and oversight for the internal GxP Computerized Enterprise systems.
- Provide QA support for validation and Qualification activities including:
- Enterprise Systems such as Veeva (Qdocs & QMS), Oracle SCM Cloud, Vineti, ServiceNow, etc.
- IT Infrastructure Systems
- Investigation and approval of Validation Excursions/Deviations.
- Provide guidance, review and approval of internal validation documents including validation plans, requirement documents (URS, FS, CS), qualification protocols, data analysis, and final reports.
- Review and approval of changes to validated computerized systems, in support of change controls (including assessment of impact).
- Provides QA support to the life cycle of computerized systems validation/verification, including qualification and validation activities.
- Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
- Ability to multitask and prioritize independently in a high paced environment.
- Thorough knowledge and understanding of FDA and foreign requirements and expectations.
- Represent the Quality Assurance Validation group in project teams, audits and inspections as required.
- Lead the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
- Provide input on the development of long-range goals and objectives.
- Exercise considerable latitude in determining objectives and approaches to critical assignments.
- Other related tasks as needed
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Wide range of expertise working in an internal GMP manufacturing or laboratory environment
- Expertise in support of Enterprise systems such as Veeva (Qdocs & QMS), Oracle SCM Cloud, Vineti, ServiceNow, etc.
- Thorough knowledge and experience with change control process
- Bachelors’ and/or Masters’ degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
- A minimum of 8-10 years of experience in the industry, ideally all clinical phases through commercial drug product.
- Knowledge of cGMP guidelines, ICH guidelines, 21 CFR part 11, Annex 11, and other international regulatory requirements.
- 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.
- Experience within a multi-product facility is a plus
- Experience leading risk based approaches (FMEA, PHA, etc).
- Strong analytical ability.
- Experience supporting internal regulatory and partner inspections.
- Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise.
- 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.