Join a venture-backed, early-stage biotech company focused on developing innovative cell-based cancer therapies. Backed by a team of expert biotechnology professionals in biologics discovery, characterization, and development, this organization is utilizing proprietary technologies to create products that via home in on and destroy tumors via genetically engineered human immune cells. The vision? Bring the company's flagship cell therapies to millions of patients who can self-administer prescribed proteins under the care of academic and community practices.
The client seeks a Director of Quality Management Systems (QMS), reporting directly to the VP of Quality. The Director of QMS will establish and manage the infrastructure and elements of the QMS department, ensuring the QMS quality unit is compliant, effective, and agile in its support of the rapidly growing organization.
The candidate will provide quality management oversight for all elements of QMS, which includes:
- Change Control
- Deviation Management
- Corrective and Preventive Action
- Document Control, Production & Process Controls, Facilities & Equipment Controls, and Material Controls
- Identification and escalation of quality system and product issues
- Define and implement quality standards and systems for development and commercial operations
- Lead the implementation and enhancement of all components of QMS function ensuring adherence to established internal standards and compliance with applicable regulatory requirements
- Prepare QMS Key Performance and Key Quality Metrics and communicate them to senior/executive management as needed
- Develop and implement the GxP e-Quality Systems, ensuring compliance with regulatory requirements, policies, standards, and procedures as they relate to computerized systems, data integrity, and validation
- Ensure the health of the internal QMS and lead the team in continuous improvement and planning for scalability
- Act as QMS Point of Contact and SME during Health Authority inspections
- Provide cross-functional support to any QMS-related requests or issues; partner in troubleshooting and investigations to ensure closure
- Responsible for operational support for key quality systems (e.g., complaints, document management, training and change control, etc.)
- Partner with VP of Quality in creation of department goals and metrics
- Represent QA on project teams and act as the main Quality point of contact for all QMS topics & initiatives.
- Promote a culture of quality and operational excellence
Requirements and Qualifications:
- A Bachelor's degree in a scientific or technical discipline is required. An advanced degree is preferred.
- A minimum of 12 years of experience in a GxP and Quality Systems in biotechnology or pharmaceutical environment is required.
- Experience in establishing infrastructure and leading QMS functions including QMS IT systems.
- Experience in building high performing teams.
- Experience in developing and implementing Inspection Readiness and PAI Plans.
- Extensive knowledge of applicable US and Global compliance regulations and industry practices.
- Ability to critically evaluate and troubleshoot complex problems and attention to detail.
- Strong leadership, collaboration and management skills.
- Ability to manage multiple priorities and aggressive timelines
- Commitment to ethical scientific investigations and rigorous experimental methods
- Ability to multitask in a fast-paced entrepreneurial environment
- Interpersonal skills that promote a collaborative and productive lab environment
- Effective and efficient written and oral communication skills