Job Description

The Position

Title: Compliance Specialist

Division: Medical and Regulatory Affairs

Location: Mississauga Campus.

This position will be located at our Mississauga campus and is a hybrid role.

The Opportunity:

The Compliance specialist works with QM team members in cross-functional teams, in helping to provide quality guidance in their areas of expertise. This includes:

Contributing with knowledge of own job discipline/chapter. Has developed a number of skills typically gained through years of professional experience.

Job Facts:

As the Compliance Specialist you will:

Interact and collaborate as required, with Quality team members, respective local supply and distribution network, global documentation providers and local regulatory affairs counterparts in order to achieve quality goals including product release to the Canadian market

Ensure that other stakeholders (RA, Logistics/Supply Chain, Drug Safety, etc.) are informed of quality timelines and provide them any necessary information required by them to complete any work they are required to.

Maintains Quality related training in a compliant manner

Understands and considers global PQS directives as well as local GMP requirements and when updating local procedures and redesigning processes

Advocate for Canadian Quality operations to ensure that all activities and actions of the QM team protect the Roche Canada License to Operate

Ensures activities are performed in a timely manner using a customer centric approach, and reported as part of the KPI (Key Performance Indicators) process, ensuring a robust Quality System

In consultation with other team members, assess and execute the processes of Planned Events (PE) including Change Controls, CAPAs and audits in a compliant manner, and look for possible improvements to the current processes and document changes

In consultation with other team members, identify quality impacting events, and execute the processes related to Unplanned Events (UPE) including deviations and customer complaints as required and, with the help of other team members, put in place effective, thoughtful Corrective and Preventative actions to ensure

Assist other teams with contributions and support for both PE and UPEs affecting the Canadian Affiliate

Responsible for reviewing all required documentation (e.g. CoA, CoM, CoP,DEL) for releasing of product (commercial and clinical) to the Canadian market ensuring compliance with Canadian regulations.

Create and accurately maintain supporting files for all aspects of product management to enable the supportive drug release and compliance to marketing authorization in compliance with Good Documentation Practices

Participate in the process drugs returned process ensuring that all activities are performed and completed to ensure Health Canada regulations are met

Ensures training systems are maintained in a compliant manner

Supports all processes to Protect Canadian License to Operate with internal and Health Canada requirements by being knowledgeable of current Canadian Quality Requirements and coaching other team members.

Participate in the evolution of the team to be self-managed and high performing team

Have a \xe2\x80\x9cWe\xe2\x80\x9d over \xe2\x80\x9cMe\xe2\x80\x9d mentality

Be open and transparent with team members to help the team function as effectively and efficiently as possible

Who you are:

Bachelor\xe2\x80\x99s Degree in science or relevant experience with a minimum of 3-5 years work experience in pharmaceutical industry - QC/QA/manufacturing preferred

Ability to adopt agile mindsets and behaviors and integrate into daily tasks

Ability to work efficiently and collaboratively within a high performing team environment and be an integral member of a self-managing team

Strong interpersonal and communication skills

Strong problem-solving skills

Strong presentation skills

Thorough understanding of Health Canada regulations and guidelines

Relocation benefits are not available for this job posting.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche\'s truly innovative culture.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.

Roche