Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the Country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!
We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds.
We’d love to hear how you could contribute to the team!
The Manager, External R&D Quality is responsible for the overall quality management of all third party contract manufacturing, testing and packaging organizations used by Apotex R&D. The incumbant is also responsible for the quality management of raw material suppliers of experimental APIs and other raw materials. The Manager is the contact person for the transition from R&D Quality to Commercial Quality.
* Responsible for the Quality management of all vendors and service providers utilized by Apotex for the manufacturer/testing of R&D stability/submission and/or biobatches
* Ensure all raw materials, intermediates and products supplied to Apotex R&D areas are of suitable quality for their intended use.
* Develop R&D Quality Agreements for all vendors/service providers of experimental materials
* Manage the adherence and revisions to the R&D Quality Agreements
* Ensure all R&D third party service providers are audited and have a current R&D quality agreements
* Oversee the product release activities for third party contract manufacturerd products for stability/submission and /or biobatches
* Represents R&D QA on cross functional teams during product launches and/or transfers from R&D to Commercial Quality
* Recruit, train and effectively manage the ongoing performance of employees
* Works as a member of a team to achieve all outcomes
* Performs all work in support of our Corporate Values of Pride, Accountability, Intergrity and Diligence
* Performs all work in accordance with all established regulatory and compliance and safety requirements
* All other duties as assigned
* B.Sc in Chemistry, Biochemistry or a related science
* Minimum 7 years of experience in the pharmaceutical industry, direct quality management experience as well as a minimum of 2 years of management experience in the pharmaceutical industry
* Excellent understanding of Canadian, US and EU Good Manufacturing Practices for the Pharmaceutical Industry
* Knowledge of new product development process of pharmaceuticals and biopharmaceuticals
* Excellent interpersonal, organizational and time management skills
* Excellent negotiation skills
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.