Senior Manager, Quality Assurance Canada

Job Description

Job Purpose

The Senior Manager, Quality Assurance acts as the Quality Manager for the Canada Affiliate, who is responsible for compliance with the applicable technical and regulatory requirements related to the quality of imported pharmaceuticals and biologic finished products and the release of such products for sale.
Additional responsibilities include providing Quality Assurance oversight and support to related affiliate activities including but not limited to maintenance of the Drug Establishment Licenses (DEL) of the Canada Affiliate, quality oversight of distribution partners. They will be responsible for performing and overseeing all quality assurance activities in Canada to ensure product quality all the way to the patient, including the oversight of consultants’ activities relating to Quality Systems and GMP/GDP activities.

Responsibilities: 

Manages the Local Quality Management Systems consistent with in-country requirements and Biogen QMS
•    Leads and coordinates implementation of the local Quality Management System in alignment with the global QMS.
•    Oversees the documentation management system for local procedures (GxP and non-GMP).
•    Responsible for the management of local Deviations, CAPAs, Change Control,
•    Complaints, and risk management.
•    Leads and coordinates the local Affiliate Quality Management Review process

Accountable for the maintenance of Canadian DEL for Biogen products and Medical Devices, and oversight of distribution partners and Contracted Laboratory Organization (CLO) 
•    Stays current on cGDP, Health Canada and other relevant regulatory requirements to ensure that Biogen products are distributed in accordance with their licenses and with applicable regulatory requirements.
•    Ensures that suppliers and customers are approved in coordination with responsible departments. Responsible for approval of any subcontracted activities which may impact  local distribution.
•    Develop and maintain quality agreements with local Logistics Partners, CLO and Wholesalers
•    Continuously monitor and assess the performance of the Logistics Partners and warehouses’ activities potentially impacting the products, including inventory levels
•    Collaborates with all necessary departments to ensure that communication to the authorities is appropriate, coordinated and approved.
•    Accountable for communication with the Competent Authorities relating to product quality and ensure that the review of this communication is appropriate and approved.

Audits and Inspections
•    Leads local health authority Inspections in relation to readiness, preparation & coordination and hosts them
•    Hosts Affiliate Audits and coordinate related follow up actions and CAPA implementation.
•    Leads and coordinates self-inspection program including audits of Logistics partners.
•    Provides oversight of local affiliate GxP vendor qualification and management, including quality agreements

Product related matters
•    Responsible for the product market release for distribution and Annual Product Quality Review.
•    Ensures that Stability documentation, including stability data generated for the products, meet stability acceptance criteria of the Canadian Certified Product Information Documentation.
•    Acts as the local coordinator for Product Recall activities and manages local mock recall exercises. Participates in Distributed Material Review Boards and Recall Committees as Quality Manager related to product distributed in the Canadian market.
•    Performs/provides quality support for Technical Product Complaint related investigations including local investigations and follows up as necessary.
•    Ensures that suspected counterfeit product is immediately notified and investigated and coordinates local management as per Biogen procedures.
•    Supports/performs temperature excursion assessments.
•    Management of returns between Biogen and logistics partners: approving or rejecting any returns into saleable stock in accordance with national law
•    Management of destruction of Finished Goods in accordance with National Law
•    Supports new product launches.

Oversees consultants’ activities
•    Provide operational support and status updates; define expectations, monitor performance, and provide feedback.
•    Oversees consultants’ activities with regards to the management of activities and records pertaining to Quality Systems in Canada. 

Perform company business in compliance with relevant regulations, company policies and procedures.

Any other duties as assigned and/or required.

 

Qualifications

•    Education
o    Minimum Bachelor of Science in Health Sciences or related discipline from a Canadian university  or recognized as equivalent by a Canadian university or Canadian accreditation body. (e.g. WES) 

•    Experience
o    Proven knowledge and experience with the regulations in Canada for the release and distribution of imported pharmaceutical and biologic products ( MRA and non-MRA products); minimum 8+ years of experience in QA/GMP roles.
o    Experience with development and maintenance of quality management systems
o    Experience with DEL and MDEL maintenance and management Experience with hosting Health Canada inspections is preferred
o    Experience with TrackWise and LIMS  is an asset

•    Skills
o    Deep knowledge of business and market dynamics
o    Able to work well with remote supervision and represent the global team’s purpose and agenda while collaborating and communicating with affiliates to ensure their requirements are well understood by the global team
o    Excellent communication and organizational skills
o    Capacity to manage conflicts and solve problems

•    Language(s)
o    Fluency in English required, proficiency with French an asset.

•    Travel
o    Occasional travel may be required 
 

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.