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- Travail à domicile
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Quality Director, Pharmaceutical

Filament Health Corp.
Burnaby, BC

Postuler rapidement

Détails du poste

Temporaire | Temps partiel | Contrat à durée déterminée
De 65 000 $ à 70 000 $ par an

Profil recherché

Biochimie
Biotechnologie
Gestion de la qualité
Microbiologie
Assurance qualité
Baccalauréat
Inspection de la qualité
Chimie
Leadership
Compétences en communication
Gestion du temps

Description complète du poste

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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Quality Director, Pharmaceutical

Director, Quality Assurance, GMP

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