Quality Assurance Manager (Remote - Quebec / Ontario)

Gilead Sciences Canada, Inc.; Vancouver; Remote; CAD 80,000 - 110,000; Full time

Job summary

Ein dynamisches Unternehmen im Bereich der Immuntherapie sucht einen engagierten Qualitätsmanager, der die Qualität und regulatorische Compliance in Kanada unterstützt. In dieser spannenden Rolle sind Sie verantwortlich für die Freigabe von Produkten, das Management von Beschwerden und die Einhaltung der Gesundheitsvorschriften. Diese Position bietet die Möglichkeit, in einem innovativen Umfeld zu arbeiten, das sich der Revolutionierung der Krebsbehandlung widmet. Wenn Sie über umfangreiche Erfahrung in der pharmazeutischen Qualität verfügen und gerne in einem dynamischen Team arbeiten, könnte dies die perfekte Gelegenheit für Sie sein.

Qualifications

• Mindestens 6 Jahre Erfahrung in der pharmazeutischen Qualität, vorzugsweise in Biologika.
• Tiefes Wissen über QA-Systeme und regulatorische Anforderungen.

Responsibilities

• Überwachung des Produktbeschwerdemanagements und Genehmigung von Untersuchungen.
• Durchführung von Audits und Qualifizierung von Behandlungszentren.

Skills

Qualitätsmanagementsysteme

Regulatorische Anforderungen

Pharmazeutische Qualität

Bilingual (Französisch und Englisch)

Organisatorische Fähigkeiten

Education

Bachelor-Abschluss in Lebenswissenschaften

Bachelor-Abschluss in Ingenieurwesen

Job description

Kite, a Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and revolutionizing personalized therapies. This dynamic environment fosters daily discoveries, including expanding our capabilities and individual potential.

We are seeking a highly motivated individual to join us in developing innovative cancer immunotherapies and translating them into patient treatments.

Position: Quality Assurance Manager

This role is part of the Gilead Sciences Canada affiliate Quality Assurance team, supporting quality and regulatory compliance activities in Canada.

This is a remote position, ideally based in Quebec or Ontario.

Key responsibilities include:

1. Release of Kite products imported for distribution in Canada.
2. Oversee product complaint management, including review and approval of investigations.
3. Review and approve Annual Product Reports.
4. Compile, review, and submit Yearly Biologic Product Reports to Health Canada.
5. Support maintenance of Drug Establishment Licences for imported products, including foreign manufacturing sites.
6. Perform lifecycle activities like batch record reviews and stability assessments.
7. Manage change controls and deviations, ensuring quality records are reviewed and approved.
8. Oversee the quality management system to ensure compliance with Health Canada regulations and Kite standards.
9. Conduct audits and qualify treatment centers, supporting their management and training.
10. Assist in inspection readiness and participate in audits and inspections.
11. Collaborate across departments to execute tasks and participate in projects representing Gilead Canada.

Additional requirements:

• Ability to travel up to 30% within Canada.
• Set and achieve goals aligned with strategic initiatives.
• Perform other duties as assigned.

Knowledge, Experience, and Skills:

• Bachelor’s degree in Life Sciences, Engineering, or equivalent.
• Minimum 6 years of pharmaceutical quality experience, preferably in biologics.
• Bilingual proficiency in French and English, with excellent communication skills.
• Deep knowledge of QA systems, manufacturing, testing, and regulatory requirements, including Health Canada GMP.
• Strong organizational skills, integrity, attention to detail, and ability to work independently and in teams.