QA Technical Operations Lead

5 months ago

Laval, Canada Moderna Full time

**The Role**:
**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**:
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

**Le Rôle**:
**Voici Ce Que Vous Ferez**:
Superviser les initiatives de mise en service, de qualification, et de validation du point de vue Qualité, y compris les projets complexes d'installations GMP ou d'utilités critiques.

Assurer la supervision de la Qualité des Transferts de Technologie de produits.

Surveiller la Qualité des déviations significatives, y compris les dossiers d'analyse des causes racines, et les contrôles de changement.

Superviser la Qualité de la Stratégie de Contrôle de la Contamination du site.

Examiner les protocoles, les évaluations des risques, les changements d'installations, et/ou les stratégies de contrôle.

Rédiger, réviser, et approuver la documentation GMP. (SOP, Formulaires, Rapports Techniques, Spécifications, etc.)

Participer aux Audits Internes et Externes, y compris les inspections des Autorités Sanitaires.

Collaborer de manière transversale pour promouvoir la Culture de la Qualité et une mentalité d'amélioration continue.

**Voici Ce Que Vous Apporterez à la Table**:
Diplôme de baccalauréat dans un domaine scientifique (par exemple, Ingénierie, Chimie) ou combinaison équivalente d'éducation et d'expérience

8 à 10 ans ou plus d'expérience de travail en pharmacie ou dans un domaine connexe, avec un accent sur les Bonnes Pratiques de Fabrication actuelles

Capacité démontrée à prendre des décisions basées sur le risque

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also conside

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