Director of Quality Assurance

GreenOnyx Ltd. is at the forefront of developing innovative, sterile cultivation solutions with applications in food and agriculture. Our goal is to uphold stringent safety and quality standards while delivering a reliable, sustainable product to our customers. To support our continued growth and address current quality challenges, we are seeking a dynamic QA Director to champion a culture of quality, compliance, and continuous improvement.

Position Summary

The QA Director will provide strategic leadership and hands-on oversight for all Quality Assurance activities within our sterile cultivation facility. integrating QA practices from the earliest stages of product development through commercial production, along with reviewing R&D and validation protocols fostering an organization-wide commitment to quality and collaboration. The QA Manager will ensure that our operations meet or exceed cGMP, HACCP, ISO, and other relevant regulatory standards.

Key Responsibilities

Quality Management System (QMS)

·      Develop, implement, and continuously improve the QMS in line with relevant regulations (cGMP, ISO) and best practices.

·      Manage document control (SOPs, batch records, manuals), deviations, CAPAs, and change controls to ensure accuracy and traceability.

Sterile Manufacturing & Environmental Control

·      Oversee aseptic techniques and environmental monitoring protocols to maintain a sterile production environment.

·      Review and approve batch records, validation protocols, and manufacturing documentation, ensuring compliance with internal and external standards.

R&D Collaboration & Protocol Review

·      Work closely with R&D from ideation through scale-up, embedding QA principles to guarantee robust traceability and documentation.

·      Provide expert review and approval for R&D protocols, validation studies, and technology transfer plans to safeguard product integrity.

HACCP & Risk Management

·      Develop and maintain the facility's HACCP program, identifying and mitigating chemical, biological, and physical hazards.

·      Conduct risk assessments (e.g., FMEA) to proactively address potential issues in production and support continuous improvement initiatives.

QC Laboratory Integration

·      Collaborate with QC to define testing protocols, specifications, and sampling plans that align with regulatory and scientific standards.

·      Oversee data integrity and ensure that any out-of-specification or deviation investigations are resolved promptly and effectively.

Supplier & Material Qualification

·      Lead supplier audits and evaluations, ensuring incoming materials meet quality requirements.

·      Maintain supplier quality agreements and corrective actions to mitigate risks throughout the supply chain.

Continuous Improvement & Quality Culture

·      Champion a culture of quality, ensuring accountability and open communication about quality-related matters across the organization.

·      Identify, lead, or support continuous improvement projects to streamline processes and enhance compliance.

Team Leadership & Training

·      Recruit, mentor, and develop QA team members, fostering an environment of growth, collaboration, and excellence.

·      Provide regular training on SOPs, best practices, and regulatory requirements to all staff.

Audit & Regulatory Engagement

·      Plan and conduct internal audits to verify adherence to established processes and identify areas for improvement.

·      Prepare for and coordinate external audits or inspections (FDA, ISO, customer audits), ensuring successful outcomes and swift issue resolution.

Qualifications

Education: Bachelor's degree in biology, Microbiology, Chemistry, or related discipline (master's preferred).

·      Experience: 7+ years in Quality Assurance within sterile manufacturing, food safety, or a similar regulated environment.

·      Technical Expertise: Proficient in cGMP, HACCP, ISO standards, and environmental monitoring; strong understanding of R&D and validation requirements.

·      Leadership: Demonstrated ability to build, mentor, and lead QA teams, driving continuous improvement and a culture of excellence.

·      Communication Skills: Excellent verbal and written communication, with the ability to collaborate cross-functionally and present complex information clearly.

·      Problem-Solving: Strong analytical skills and a proactive, solution-oriented approach to quality challenges.

Why Join Us?

Impactful Role: You'll be pivotal in shaping our QA strategy and culture, addressing current challenges, and laying a foundation for future success.

Innovative Environment: Collaborate with a forward-thinking R&D team in a rapidly evolving industry, exploring new frontiers in sterile cultivation.

Career Growth: We invest in our people, offering professional development opportunities and a clear path for advancement.

Inclusive Culture: Join an organization that values open communication, integrity, and teamwork across all levels.