Job Overview
Filament Health is a small clinical-stage natural psychedelic drug development company. We are seeking a Part-Time Quality Director (remote) to provide oversight of GMP and regulatory quality activities over a 16-month contract term.
The ideal candidate will lead the development, implementation, and continuous improvement of quality management systems and provide ongoing support to the on-site Quality Manager. This role requires a strategic thinker with a strong understanding of Canadian and international guidelines for clinical trial drug manufacturing. The Quality Director will collaborate across departments to foster a culture of quality, compliance, and operational efficiency.
Key Responsibilities
- Oversee all GMP programs and support the Quality Manager
- Ensure all GMP documentation aligns with IMPDs and DMFs
- Stay informed on changes in regulatory guidelines across multiple jurisdictions and ensure programs meet requirements
- Lead third party audits including internal preparation and provision of documentation
- Ongoing review and management of change control and CAPAs
- Provide oversight of stability programs (protocols, schedules, reports)
- Support EU regulatory activities, including RFI responses, regulatory requirement review, and IMPD updates
- Act as the main QA contact for NNHPD, including renewal applications, RFIs, and ePLA submissions
- Provide regulatory support for Health Canada and FDA, including DMF updates and RFI responses
- Review and approve quality agreements
Qualifications
- Senior-level experience in Quality within pharma or biotech
- Experience managing people and cross-functional teams
- Strong knowledge of drug development and regulatory submissions (IMPDs, DMFs, etc.)
- Strong communication skills for reporting findings and collaborating across departments
- Demonstrated expertise in QA processes and third party audits
- Experience with botanical drugs an asset
- Familiarity with EU, Health Canada, and FDA regulatory frameworks
- Ability to work independently in a remote, part-time role
- Ability to be on-site as needed
- Proficiency with Google Workspace
- Bachelor of Science (BSc), Microbiology, or Biochemistry
- cGMP Compliance Training: HACCP, cGMP, SQF, regulatory compliance
Job Types: Part-time, Fixed term contract
Contract length: 16 months
Pay: $65,000.00-$70,000.00 per year
Expected hours: 20.0 – 25.0 per week
Benefits:
- Paid time off
- Work from home
Work Location: Hybrid remote in Burnaby, BC V5G 4X4
