ElevateBio · 2 days ago
Director, Quality Systems & Compliance
Waltham, Massachusetts, United States
Full-time
Onsite
Director/Executive
$220K/yr - $250K/yr
12+ years expElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. The Director, Quality Systems and Compliance will provide strategic direction and oversight of the Quality Systems and Quality Compliance functions to ensure regulatory requirements and industry best practices are met.
BiotechnologyGeneticsLife ScienceTherapeutics
Responsibilities
Responsible for the Quality Systems of:
Documents and Records Management
GxP Training and Learning Management
CAPA, Deviation and Change Control Management
Quality Risk Management
Supplier Quality Management
Audits and Inspection Management
Digital Quality Management
Manage and develop the teams responsible for the Quality Systems and Compliance
Serve as the business system owner for the electronic DMS, LMS and QMS
Drive strategic planning for the QMS, including establishing short and long-range quality planning objectives in collaboration with cross-functional stakeholders for continuous improvements
Manage key quality performance metrics and data, collaborating with stakeholders to continually review and refine the quality metrics
Ensure the site remains inspection-ready through self-inspection, internal quality audit and inspection-readiness programs
Host and coordinate client quality audits
Lead and facilitate Quality meetings, Supplier Review Board and Quality Management Review
Responsible for efficient and phase-appropriate Supplier Quality Management program elements, with close interdependence to the Material Quality program
Promote a culture of Quality and GxP continuous improvement across the organization including training initiatives
Support new GxP business opportunities, address GxP risks or enhancements to cross-functional quality systems
Qualification
Required
Minimum of 12+ years biopharmaceutical experience; 7+ years management experience in Quality Operations and Quality Management Systems
Expert knowledge in global GxP regulations and the ability to interpret and implement these requirements
Experience in regulatory inspections
Ability to think strategically and to influence others
Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks
Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems
Appreciation and desire to operate within a completely digital environment
Company
ElevateBio
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come.
201-500 employees
H1B Sponsorship
ElevateBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (19)
2023 (17)
2022 (6)
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$14M2021-03-23Angel· $14M
Leadership Team
Vikas Sinha
Chief Financial Officer
Michael Paglia
Chief Operating Officer, ElevateBio BaseCamp
Recent News
2024-05-10
Company data provided by crunchbase