QA Technical Operations Lead

5 months ago

Laval, Canada Moderna Full time

**The Role**:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

In Laval, Moderna's long-term strategic partnership with the Canadian Government is reshaping the nation's pandemic preparedness and response capabilities. Our upcoming state-of-the-art mRNA vaccine manufacturing facility will play a critical role in ensuring rapid access to vaccines for respiratory viruses. We are dedicated to investing in local talent and fostering research and development collaborations, strengthening Canada's role as a global center of mRNA excellence.

Moderna is seeking a QA Technical Operations Lead in Canada. Reporting to the Site Quality Head, this individual will be integral in supporting cGMP mRNA drug substances produced at Moderna. The role involves quality oversight of manufacturing operations, technology transfer projects, and GMP facility aspects, requiring a dynamic range of skills and experience in quality oversight or manufacturing of commercial products.

**Here’s What You’ll Do**:
Provide Quality oversight for commissioning, qualification, and validation initiatives including complex GMP facility or critical utility projects

Provide Quality oversight of product Technology Transfers

Provide Quality oversight of significant deviations, including root cause analysis records, and change controls

Provide Quality oversight of the site Contamination Control Strategy

Review protocols, risk assessments, facility changes, and / or control strategies

Writes, reviews, and approves GMP documentation. (SOPs, Forms, Technical Reports, Specifications, etc.)

Participate in Internal and External Audits, including Health Authority inspections

Collaborate cross-functionally to enable Quality Culture and a continuous improvement mindset

**Here’s What You’ll Bring to the Table**:
Within 3 Months, You Will

Provide Quality oversight for commissioning, qualification, and validation initiatives, including GMP facility or critical utility projects.

Begin Quality oversight of product Technology Transfers.

Start overseeing significant deviations, including root cause analysis records and change controls.

Within 6 Months, You Will

Implement Quality oversight of the site Contamination Control Strategy.

Review and provide input on protocols, risk assessments, facility changes, and control strategies.

Write, review, and approve GMP documentation such as SOPs, Forms, Technical Reports, and Specifications.

**Within 12 Months, You Will**:
Actively participate in Internal and External Audits, including Health Authority inspections.

Collaborate cross-functionally to enable a Quality Culture and foster a continuous improvement mindset within the organization.

Demonstrate a strong ability in making risk-based decisions, contributing to the overall quality and compliance of the facility.

**Here’s What You’ll Bring to the Table**:
Bachelor’s Degree in a science field (e.g., Engineering, Chemistry) or equivalent combination of education and experience

8 - 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices

Demonstrated ability making risk based decisions

Fluency in French and English as working language.

**Le Rôle**:
Rejoindre Moderna, c'est participer à une équipe pionnière qui révolutionne la médecine avec la technologie de l'ARNm et un large éventail de programmes de développement couvrant diverses maladies. En tant qu'employé, vous ferez partie d'une organisation en croissance continue, travaillant aux côtés de collègues exceptionnels et de partenaires stratégiques dans le monde entier, contribuant aux initiatives de santé mondiale. L'engagement de Moderna à faire avancer la frontière technologique des médicaments à ARNm garantit une expérience de carrière stimulante et gratifiante, avec un impact significatif sur la vie des patients partout dans le monde.

À Laval, le partenariat stratégique de Moderna avec le gouvernement canadien transforme les capacités du pays en matière de préparation et de réponse aux pandémies. Notre future installation de fabrication de vaccins à ARNm de pointe jouera un rôle crucial pour assurer un accès rapide aux vaccins contre les virus respiratoires, sous réserve de l'approbation de Santé Canada. Nous investissons dans le développement des talents locaux et favorisons les collaborations en recherche et développement, renforçant ainsi la posit

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