Compliance Specialist - Jobs in Mississauga, ON

Job Description

Leading and Collaborating in Quality ProcessesThe Quality Management Associate is accountable for participation in cross-functional teams, providing quality guidance in their areas of expertise. This includes:

• Contributing with in-depth knowledge of own job discipline/chapter. Has developed a number of skills typically gained through years of professional experience.
• Responsible for interaction and collaboration, 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
• 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
• 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
• Continuously identifies process improvements, and takes steps to develop ideas within the team and implement them effectively
• Responsible to develop and build 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.

Operational Responsibilities as required:

• 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
• Leads Audits for Canadian suppliers, manages local self inspections and key participant in corporate and regulatory audits
• Designs, writes and negotiates Quality Agreements with internal stakeholders and external vendors
• 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
• Responsible to effectively identify quality impacting events, and execute the processes related to Unplanned Events (UPE) including deviations and customer complaints as required and put in place effective, thoughtful Corrective and Preventative actions to ensure compliance and improve processes where applicable, always considering the impact to the UPE and other processes
• Advise and assist other teams with contributions and support for both PE and UPEs affecting the Canadian Affiliate
• Responsible for making critical expert decisions regarding release of product to the Canadian market ensuring compliance with Canadian regulations. Acts as delegate RP (responsible person) to release product
• 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
• Assess and process drugs returned as per procedure and Health Canada regulations
• Develops procedures and designs effective processes with consultation and collaboration with team members and team leads in line with global PQS and GMP requirements
• Responsible for maintenance of the Drug Establishment License (DEL) and Medical Device Establishment License (MDEL) and ensure local and global changes are incorporated into the applicable license
• Ensures all Canadian GMP processes are effectively managed, to ensure products launched to the Canadian Market are compliant
• Ensures training systems are maintained in a compliant manner
• Identifies and manages other compliance activities as required
• Ensures Roche Canada always operates in compliance with Canadian GMP and other applicable government regulations, guidelines and policies, including all foreign supply sites.

Leading Quality Education and CollaborationQuality Management Associate is accountable 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.
• 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

Development and Evolution of Team(s)

• 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
• Accountable to ensure new team members are 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

• Education / Skills / Knowledge / Experience Required

• Bachelor’s Degree or relevant experience with a minimum of 7-10 years work experience in pharmaceutical industry - Quality Assurance preferred
• Proven experience in the pharmaceutical/biotech industry in Quality Assurance/Management Department
• 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

Important:Relocation benefits are not available for this job posting.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s 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 Roches 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.Job Level:Individual contributorQuick Apply

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