Quality Portfolio Lead - Mississauga

Company: Confidential
Your Application: You have not applied yet
Location: Mississauga, Canadá
JOB DESCRIPTION

ABOUT THE ROLE
The Quality Portfolio Lead reporting to the Director, Scientific Affairs Drug Safety & Quality; Ethics and Compliance Officer, will act as a subject matter expert in leading the implementation of various aspects of the quality framework for Specialty Program Portfolio.
Please note:
This is a hybrid role requiring to work from our Mississauga office twice a week.
WHAT YOU BRING TO THE TEAM
* Leads the implementation of quality initiatives and framework across the Specialty Program Portfolio under the direction of Director, Scientific Affairs; Ethics & Compliance Officer.
* Collaborates with cross functional internal team and external stakeholders.
* Supports business development and RFP responses related to the Quality Portfolio, including DSMI operations and PSP services.
* Maintains quality management system policies and procedures in line with GxP regulations.
* Leads the administration and training initiatives on Quality Management Systems, including document and risk management processes.
* Drives quality process improvements and play a vital role in creating and revising Specialty Program Portfolio and division wide standard policy documents and standard operating procedures.
* Utilizes technical and business writing skills to effectively communicate system process changes across the Specialty Program Portfolio.
* Drives the implementation of standard practices for maintaining professional records for department staff.
* Conducts investigation and follow-ups for any Ethics and Compliance issues and educate the internal team on the

escalation process.
* Facilitates Ethics and Compliance Committee meetings.
* Responsible for the following audit/self-inspection readiness related activities:
? Maintains key audit/inspection readiness documents to ensure the most up- to-date version and correct documents are available in the repository at all times.
? Leads the coordination of internal and external audits/inspections including but not limited to:
audit scheduling, pre-audit training, logistics, audit runner, document follow-up, and CAPA tracking.
? Lead internal self-inspections for the Specialty Program Portfolio.
* Provides guidance and educate cross-functional teams on conducting root cause analysis, investigations and writing effective CAPAs.
* Conducts compliance risk assessments, trend analysis, and provide solutions and recommendations for improving quality and compliance.
* Acts as a back-up for PV QA Lead and be audit facing in external Pharma PV Audits.
* In-accordance with GMP and GDP guidelines, co-lead in running document change control meetings and in effectively managing the review & approval process for documents, ensuring version control.
* Monitors Health Canada regulatory and quality requirements and proactively adapt the internal processes to meet the changing requirements.
* Perform other quality and compliance related division wide duties as assigned.




JOB TYPE
Work Day: Full Time
Employment type: Permanent Job
Salary: Negotiable


JOB REQUIREMENTS
Minimal experience: Unspecified



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