Job Description

The Position



Title: Quality Management Associate
Chapter: GxP Quality and Compliance
Location: Mississauga Campus (Hybrid)
Type: 1 Year Contract

The Opportunity:

The Quality Management Associate works strategically and collaboratively with the Quality
Management Team, internal networks (locally and globally) and Health Canada to ensure
compliance of product and systems to Pharma Quality System (PQS) and Health Canada
requirements. This is achieved by ensuring Roche Canada functions in compliance with the
Pharma Quality System (PQS), and Good Manufacturing Practices (GMP and Medical Device)
regulations. The Quality Management Associate works with local and Global teams in order to
achieve the best possible outcomes in the best possible timeframe while always exploring
different ways to achieve success with all Health Canada requirements. They, along with the
team are responsible and accountable for the Roche Canada License to Operate.

Job Facts:

The Quality Management Associate is accountable for participation in cross-functional teams,
providing quality guidance in their areas of expertise as well as performing quality activities to ensure
compliance with Health Canada and Roche requirements

This includes:

Accountable for participation in cross-functional teams, providing quality guidance in
their areas of expertise, using their in-depth knowledge, which has been developed
through years of professional experience.
Responsible for interaction and collaboration, with Quality team members, 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
Lead and contribute with expertise to projects/squads
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
Responsible for participation in cross-functional teams, to understand and advise on the
nuances of Canadian Quality regulations and requirements
Maintain Quality related training in a compliant manner
Understand and consider global PQS directives as well as local GMP requirements and
when updating local procedures and redesigning processes
Continuously identify process improvements, and take steps to develop ideas within the
team and implement them effectively
Assist in developing new processes for identified gaps/improvements

Advocate for Canadian Quality operations and employs higher level thinking to ensure
that all activities and actions of the QM team protect the Roche Canada License to
Operate
Responsible to use enterprise thinking to effectively assess and execute the processes
of Planned Events (PE) including Change Controls, CAPAs and audits in a compliant
manner, and continuously improve processes and document changes
Initiate and support changes impacting products and processes, ensure activities are
performed in a timely manner using a customer centric approach
Responsible to identify quality related issues, and execute the processes related to
Unplanned Events (UPE) including deviations and customer complaints
Initiate UPE records, conduct investigations, root cause analysis and identify CAPAs to
ensure compliance to internal procedures and regulatory requirements
Perform commercial and clinical batch releases to the Canadian market ensuring
compliance with Health Canada regulations for imported drug products and Medical
Devices
Assess and process drugs returned as per internal procedure and Health Canada
regulations
Develop procedures and design effective processes with consultation and collaboration
with team members and team leads in line with global PQS and GMP requirements
Support or lead Audits of Canadian suppliers, perform local self-inspections and key
participant in corporate and regulatory audits
Design, write and negotiate Quality Agreements with internal stakeholders and external
vendors
Ensure all Canadian GMP processes are effectively managed, to ensure products
launched to the Canadian Market are compliant
Ensure training systems are maintained in a compliant manner
Identify and manage other compliance activities as required
Ensure Roche Canada always operates in compliance with GMP, Health Canada
regulations and other applicable government regulations, guidelines and policies,
including all foreign supply sites

The Quality Management Associate is accountable to Protect Canadian License to Operate and support
the Quality Management Team by:

Being knowledgeable of current Canadian Quality Requirements and coaching other
team members
Working to understand the importance of effective management of quality systems and
how strong processes can improve compliance and facilitate robust and agile operations
and implement process improvements based on the regulations and systems
Understanding and sharing Good Documentation Practices (Including electronic
systems) in order to ensure and improve Quality Systems and operations in a compliant
and robust manner
Maintaining knowledge of Quality requirements gathered through continuing education
and internal and external training
Participate in the evolution of the team to be self-managed and high performing team

Onboarding new team members with regards to all required local processes (SOPs) and
ensuring all system access is attained for new members
Support new team members to be capable and competent in executing their processes
and performing quality operations
Based on technical experience and time within the team, the senior team member may
also act as a coach and/or mentor for new team members to ensure that they are
achieving the required technical knowledge as well as the mindset and behaviors
required to be successful within the team and beyond
Acts as a coach for colleagues with less experience and provides guidance

Who you are:
Bachelors Degree or relevant experience with a minimum of 5 years work experience in
pharmaceutical industry - Quality Assurance preferred
Proven experience in the pharmaceutical/biotech industry in Quality Department
Training and work experience in deviation management and root cause analysis
Demonstrate sound decision making relating to quality issues
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
Ability to communicate effectively with all areas of the business (local and Global) and
across cultures
Strong problem-solving skills
Strong project management and planning 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, weve become one of the worlds 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