Job Description

TITLE: SR. MANAGER / MANAGER, QA VALIDATION

LOCATION: WALTHAM, MA

REPORTS TO: DIRECTOR OF QA VALIDATION

THE ROLE:

ElevateBio is looking for a Sr. Manager / Manager of QA Validation to join their growing Quality group. In this role the Sr. Manager / Manager of QA Validation function at ElevateBio will be responsible for managing cGMP compliance from a Quality Assurance prospective of process, facility, utilities, equipment, analytical instruments, method, and computer system validation. In addition, this position with support all Commissioning, Qualification, and Validation activities at our next generation facility and laboratories. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals.

HERE’S WHAT YOU’LL DO:

• Provide QA oversight of commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories.
• Provide QA oversight of clinical engineering runs and process validation testing.
• Change control assessment and approval to assure proper impact assessment and sufficient testing to develop and maintain a validated state.
• Review and assist in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments.
• Manage/complete Quality Risk Assessments (QRA) for facility and engineering activities.
• Administrator for the Kneat paperless validation system including user management and training.

REQUIREMENTS:

• Bachelor’s Degree in engineering, life sciences or related field with 6+ years of validation and/or quality assurance experience
• Strong knowledge of 21 CFR, ICH, EU regulations, GAMP 5, ASTM-E2500
• Prior experience in Cell and Gene Therapy manufacturing a plus.
• Experience in Analytical Instrument Validation (AIV) and Process Validation (PV) preferred.
• Experience with Kneat paperless validation system desired.
• Strong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint)
• Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
• A team player, who listens effectively and invites response and discussion.
• A collaborator who communicates in an open, clear, complete, timely and consistent manner.

WHY JOIN ELEVATEBIO?

ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities. ElevateBio is also a leader in corporate philanthropy and has taken a pledge to donate a portion of product sales to fund promising cancer research and to support cancer care in the developing world.

At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.

OUR VISION: Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Powered by JazzHR

ljMrpvw1e2