Job Description

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 92% of our employees are proud to say they work for AbbVie. 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, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. We are presently recruiting for a Commercial Quality Specialist 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 post market and distribution for biologic/drug products, NHPs, cosmetics and medical devices for the Canadian market in accordance with Company standards, registrations and Canadian regulations.
• Primary responsibility focusing on processing product returns, stability reviews and including but not limited to, annual product reviews, yearly biologic product reports, full confirmatory testing and executed batch record review, ensuring Canadian GMP Annual Commitments are met
• Create and 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 and external stakeholders as part of the post market and distribution team for new product launch projects, product discontinuations, product returns 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 quality related duties or projects, as assigned.

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 Abbvie product areas (NHP, OTC/DIN, Biologic, Medical Devices).
• Excellent interpersonal, oral and written communication skills.
• Demonstrated leadership in managing projects 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 returned Drug/Biologic/ Medical Device and Cosmetic products are dispositioned in compliance with regulatory commitments and Canadian GMPs.
• Ensure assigned annual commitments are reviewed in a timely manner and in compliance with regulatory commitments and Canadian GMPs
• Provide assistance and input for quality improvements through Root Cause Analysis and measurements.
• Establish and maintain effective relationship with Abbvie Corporate and Affiliates and any relevant services providers.
• Ability to travel as per job function requirements.
• Authority to Act:

o Approval of GMP documentation for Quality Assurance Department
o 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 - Fluent

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.

AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply. 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 including disability/vets. It is AbbVie?s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person?s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.