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.

Qualifications

WHAT YOU BRING TO THE TEAM

• Professional Scientific degree and/or combination of Quality, Regulatory Certification.
• Minimum four (4) years of previous experience working with Quality and Regulatory initiatives in a healthcare setting.
• Experience handling Regulatory Board of Health Inspections and Global Pharma Compliance Audits a must.
• Working experience/knowledge in Drug Safety-Pharmacovigilance Post-Marketing Regulatory Compliance commitment and RMPs an asset.
• Quality Auditor certification an asset.
• Experience working in Pharmaceutical GMP Quality and/or Regulatory environment.
• Experience using TrackWise QMS or other QMS applications.
• Well versed with GxP documents and GxP regulations.
• Effective business writing skills are required.
• Effective technical writing skills in writing policies, standard process documents, work instructions etc.
• Experience in handling internal and external Pharma audits and/or board of health inspections, including but not limited to GVP inspections.
• Experience in CAPA planning and follow-ups.
• Knowledge of current Pharmaceutical Quality Systems and Compliance standards.
• Experience working with Quality Systems including but not limited to: Document Management Systems, Change Control System, and Quality Management System.
• Knowledge of ICH (International Conference on Harmonization), GDP (Good Documentation Practices), GCP (Good Clinical Practice), GMP (Good Manufacturing Practices), Health Canada GVP (Good Pharmacovigilance Practices), Health Canada guidelines for Reporting Adverse Reactions to Marketed Health Products, Global PV regulations, Pharmacovigilance post marketing compliance audits, Medical Information (MI) practices, ASQ, and ISO guidelines.

Bayshore is committed to a high quality and safe environment for both our staff and clients/patients. At Bayshore all new hires must have received the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada (e.g., two doses of a two dose vaccine series or one dose of a single- dose vaccine series); AND have received the final dose of the COVID-19 vaccine at least 14 days prior to the official start date of hire. Medical exemptions or any other kinds of requested exemptions based upon Human Rights Code will be considered on a case-by-case basis.