About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Joining AbbVie means, you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada whereby 98% of our employees are proud to say they work for AbbVie and 96% are proud of how we contribute to the community. When choosing your career path, choose to be remarkable. AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health, in addition to products and services across its Allergan Aesthetics portfolio. We are presently recruiting for a Quality Specialist, Third Party Quality based in our Markham, Ontario office. This is a full-time position reporting to the Sr. Manager, Commercial Quality. JOB SUMMARY Responsible for core Quality Assurance activities related to the disposition of biologic/drug products, NHPs, cosmetics and medical devices for the Canadian market in accordance with Company standards, registrations and regulations. Primary responsibility to review batch records, testing, validations, change controls and master documentation of manufacturers, suppliers, and partners in order to perform market release Assist investigations into product non-conformances and deficiencies, ensuring that all investigations are properly documented, and that corrective actions for prevention of reoccurrence are completed in a timely manner. Collaboration with various internal departments as part of product release and new product launch projects and other initiatives, as well as assisting in a variety of regulatory related support activities as required. Monitor quality system KPIs and trends and participate in internal/external audit preparation and systemic CAPAs. Active participation in developing and implementing Standard Operating Procedures (SOPs), local processes to ensure compliance with regulations, Abbvie corporate standards, and contractual agreements. Perform other related duties or projects, as assigned. Qualifications MINIMUM REQUIREMENTS Education and Experience: Must hold a Canadian science degree B.Sc. (e.g., Biochemistry, Biology, Microbiology, Chemistry, etc.).or equivalency in a relevant discipline coupled with a minimum of 5 years Quality Assurance/Quality Control experience in the pharmaceutical industry. Experience in Pharmaceutical Manufacturing or Laboratory environments is preferred. Strong knowledge of Health Canada regulations and guidelines in at a minimum one of the Allergan product areas (NHP, OTC/DIN, Biologic, Medical Devices). Excellent interpersonal, oral and written communication skills. Demonstrated leadership in managing projects and/or product launches and ability to work independently. Excellent negotiation, problem solving, and prioritization skills. Ability to work in a team, both in person and remotely and across various departments. Essential Skills and Abilities: Act with great deal of precision and thoroughness to ensure all Drug Products/Biologics/ Medical Devices and Cosmetics products are released in compliance with regulatory commitments. Provide assistance in quality improvements through Root Cause Analysis and measurements. Establish and maintain effective relationship with Abbvie Corporate and Affiliates and any relevant services providers. Responsible for regulatory and compliance review for Canada for QA activities related to Drug Products. Execute quality strategy for the portfolio assigned including but not limited to Product Release, Deviations, CAPA and Metrics. Ability to travel as per job function requirements. Authority to Act: Approval of GMP documentation for Quality Assurance Department Approval for restock of returned drugs Time Management skills Communication Skills (Verbal and Written) with Internal and External Customers (e.g., Health Canada, AbbVie Global) Ability to work with minimum supervision Strong interpersonal skills Intermediate knowledge of MS Office (Word, Excel and PowerPoint) Language proficiency: Written and spoken English - Medium level Working Conditions In this role the incumbent may spend long hours sitting and using office equipment and computers. There may also be some light lifting of supplies and materials from time to time. The incumbent may have to manage several projects at one time, and may be interrupted frequently to meet the needs and requests of other internal or external parties. The incumbent may find the environment to be very busy and will need excellent organizational and time and stress management skills to complete required tasks within possible tight deadlines. Sensory demands include use of the computer, landline phone and cell phone. Covid vaccination new hires amendments: Full vaccination against COVID-19 is a condition of employment for this position, with possible accommodation for validated exemptions, within the limits of applicable legislation. AbbVie employees are also required to comply with any COVID-19 related external requirements, including any testing requirements, applicable to their work activities outside AbbVie premises (for example, travelling and visiting stakeholders and customers). AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply. Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.