Quality Manager

1 month ago

Dartmouth, Canada DeNova Full time

**About DeNova**

DeNova is an early-stage biotechnology company based in Dartmouth, Nova Scotia, dedicated to developing socially and environmentally responsible food solutions through microbial fermentation. DeNova’s diverse and collaborative team is currently focused on scaling its proprietary continuous fermentation technology and bringing its all-natural, nutrient-dense Single Cell Protein (SCP) product, Psomi, to market within two years. DeNova, a woman-founded and led organization, is deeply committed to addressing complex global challenges and developing innovative approaches to enhance the resiliency and sustainability of our global food systems.

**Role Overview**

**Key Responsibilities**
- Quality Management System (QMS) Development:

- Lead the development and implementation of a comprehensive QMS, aligning with regulatory frameworks and preparing for future GMP certification.
- Establish and monitor quality policies, procedures, and KPIs to drive continuous improvement.
- Collaborate across teams to ensure the QMS supports commercialization and scalability.
- Lead quality improvement initiatives and recommend new technologies or systems to enhance operational efficiency.
- Regulatory Compliance:

- Stay informed about relevant regulations in the biotech and food industries, particularly those related to microbial protein production and aquafeed.
- Ensure DeNova's processes and documentation are aligned with current Good Manufacturing Practices (cGMP) and other relevant standards.
- Prepare the company for regulatory inspections and audits, including developing inspection readiness protocols and conducting mock audits.
- Liaise with regulatory bodies as needed and support the preparation of regulatory submissions.
- Document Control:

- Design and implement a document management system that aligns with regulatory requirements and industry best practices.
- Oversee creation, review, approval, and updates of SOPs to prioritize quality, safety, and operational efficiency.
- Manage controlled document lifecycles, ensuring version control, accessibility, and regulatory compliance.
- Develop a document hierarchy and electronic document management system for streamlined access and traceability.
- Stay informed about advancements in document control systems and recommend improvements to optimize workflows.
- Training and Development
- Develop and deliver training on document control, quality assurance systems, and regulatory requirements.
- Maintain up-to-date training records and foster a quality culture across the organization.
- Provide expertise in quality practices, ensuring consistent, high standards.

**Key Qualifications**
- Education
- Bachelor’s degree or higher in Life Sciences, Biotechnology, Quality Management, or a related.
- Experience
- 7+ years of experience in quality assurance within a regulated environment (biotechnology or related industries).
- Proven experience developing and managing SOPs and quality systems, with an emphasis on documentation control processes.
- Experience in GMP environments and familiarity with regulatory requirements for biotech or food production.
- Track record of successfully implementing and maintaining quality management systems.
- Skills
- Strong organizational and document management skills, with experience in creating, reviewing, and maintaining technical documentation.
- Excellent communication and collaboration abilities, with a track record of working effectively in cross-functional teams.
- Proficiency in quality management and document control systems.
- System-thinking and analytical mindset, capable of identifying process improvements and ensuring compliance with regulatory standards.
- Adaptability and resilience in a fast-paced, growing organization.

**How to Apply

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