- 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
- 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.
- 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.
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Director, Quality Systems and Compliance - Watertown, United States - ElevateBio
Description
ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.
The Role:
The Director, Quality Systems and Compliance provides strategic direction and oversight of the Quality Systems and Quality Compliance functions at ElevateBio to ensure execution and performance meets regulatory requirements and current industry best practices. You will be responsible for ensuring that ElevateBio's Quality Management System (QMS) enables and facilitates compliance in a phase-appropriate manner from early clinical phase projects through commercial operations. In this role you will manage the teams responsible for providing day-to-day support of the Quality Systems, Compliance and Supplier Quality functions.
The successful candidate will also actively communicate goals and timelines to align team members and cross-functional stakeholders on Quality milestones and deliverables. You will further develop, maintain, and continually improve the QMS. Additionally, this role is responsible for the audit programs, including self-inspections, client audits, supplier audits, and regulatory inspections at our BaseCamp facility.
Here's What You'll Do:
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.
Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.
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.
