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Job Post Details

Quality Director, Pharmaceutical - job post

Filament Health Corp.
Burnaby, BC V5G 4X4•Hybrid work
$65,000–$70,000 a year - Temporary, Part-time, Fixed term contract

Job details

Pay

  • $65,000–$70,000 a year

Job type

  • Fixed term contract
  • Temporary
  • Part-time

Location

Burnaby, BC V5G 4X4•Hybrid work

Benefits

Pulled from the full job description

  • Paid time off
  • Work from home

Full job description

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

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