**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 sciences + 5 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 products + Strong understanding of Good Documentation Practices + Must be able to understand and utilize complaint database software and reporting tools + SAP, MS Office, Adobe Suite + Bilingual French strongly preferred + Occasional 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 Skills + Interpersonal skills-must be proactive, personable, flexible, team-oriented + Ability to multitask in a stressful environment and to operate in a constantly changing environment + Strong 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. \#GD-SG ​ \#LI-GZ \#LI-Onsite **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _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 (https://myflex-benefits.ca/en/home/) . 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 (https://myflex-benefits.ca/fr/home/) . Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)