Reference No. R2819973 

Position Title: Specialist, Quality Assurance

Department: Quality DCV & GEM

Location: Toronto, ON

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Contribute to establishing and maintaining high quality and compliance status of all products handled by Sanofi Canada to meet all Canadian cGMP regulations, as well as corporate requirements.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Coordinates with QA Coordination Call Center to obtain essential information required to document technical complaints

Provides support to QA Coordination Call Center to meet needs of the complainant

Identifies and confirms inquiries as product technical complaints

Evaluates complaints for severity and risk to public safety.

Notifies interested departments (eg. Country Quality Head, manufacturing site QA,) upon receipt of critical complaints.

Monitors and tracks sample receipt from complaints.

Ensures complaints are reviewed and processed within a timely fashion

Prioritizes complaints for data entry and processing into the global database

Utilizes the customer service database to oversee complaint identification and processing

Interacts with both internal and external manufacturing sites regarding technical complaints and their associated investigations

Performs QC Checks

Understands Health Canada complaint regulations for drug products and medical devices

Performs file review and administrative closure for individual complaints

Produces trending reports

Monitors open complaint activity for each manufacturing site

Interacts with Customer Service, Medical Information, Pharmacovigilance and other company departments/associates regarding the identification and evaluation of technical complaints

Identifies and reports adverse events within one business day to Pharmacovigilance

Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management

Participates on ad-hoc teams regarding product-specific complaint issues

Supports during regulatory, third party, and internal audits

Understands product specific information regarding common product complaints

Understands department process flows and complaint databases

Coordinates feedback to customers regarding complaint investigations via QA Coordination Call Center

Other QA duties, as assigned

About You

Requirements & Qualifications

B.Sc. in Chemistry, Biology or related sciences5 years of related experience within the pharmaceutical industry. Knowledge of cGMPs and Health Canada regulations regarding drugs, medical devices, combination products, biologics and natural health productsStrong understanding of Good Documentation PracticesMust be able to understand and utilize complaint database software and reporting toolsSAP, MS Office, Adobe SuiteBilingual French strongly preferredOccasional travel: Position is based out of the Toronto office*Persons applying for positions in QA must provide evidence of qualifications, as outlined in current Canadian Good Manufacturing Practices (GMP) Guidelines for review and assessment as a condition of any offers of employment.

Preferred skills:

Problem Solving mindset who is self-motivated, well organized with attention to detail and strong analytical skills.Customer Service Skills, Project and Time Management SkillsInterpersonal skills-must be proactive, personable, flexible, team-orientedAbility to multitask in a stressful environment and to operate in a constantly changing environmentStrong Verbal and Written Communication Skills

*Persons applying for positions in QA must provide evidence of qualifications, as outlined in current Canadian Good Manufacturing Practices (GMP) Guidelines for review and assessment as a condition of any offers of employment.

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs

This position is for a current vacant role that we are actively hiring for.​

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

North America Applicants Only

The salary range for this position is:

$76,200.00 - $110,066.66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

La fourchette salariale pour ce poste est la suivante:

$76,200.00 - $110,066.66

Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociau de l'enterprise. Des informations supplémentaires sur les avantages sont disponibles via le lien.