Director, Scientific Affairs & Quality Assurance
Canada, Toronto
Parttime: 0 hrs a week / CA$ 150000 - 160000 per year
Experience: > 10 Years
Pharmaceuticals
Introduction
Director, Scientific Affairs & Quality Assurance
Toronto, ON
What are you going to do
Responsibilities
Quality Assurance
- Oversee maintenance and submission of Drug Establishment Licenses (DEL) and Medical Device Establishment Licenses (MDEL), including new applications, amendments, and renewals.
- Lead assessment and implementation of new or revised regulatory requirements impacting the Quality Management System (QMS).
- Ensure audit readiness and compliance across all QMS components, including document control, vendor qualification, CAPA systems, change control, audit management, validation, qualification, and post-market surveillance.
- Provide oversight for warehouse, storage, distribution, and transport logistics quality compliance.
Patient Support Program (PSP) Leadership & Compliance
- Serve as an advisor on all pharmacovigilance and patient safety matters related to PSP operations.
- Act as the primary client contact for pharmacovigilance and patient safety activities.
- Engage with client pharmacovigilance leadership and participate in RFP processes for new PSP opportunities.
- Lead PSP audits, maintain compliance with client requirements, and track program KPIs.
Pharmacovigilance
- Oversee pharmacovigilance activities across all business units, ensuring adherence to Health Canada and client reporting standards.
- Maintain validated systems for recording, evaluating, and tracking adverse events and adverse drug reactions.
- Ensure timely reporting per client agreements and Health Canada regulations.
- Lead inspection and audit readiness for client, vendor, and regulatory pharmacovigilance reviews.
Patient Safety Compliance
- Act as Privacy Officer for PSPs, providing oversight on privacy and medication incident management compliance.
- Partner with internal privacy and quality teams to ensure alignment across all programs.
Personnel Leadership
- Foster engagement, accountability, and collaboration across teams.
- Coach and mentor both direct and indirect reports.
- Champion continuous improvement initiatives across the department.
Additional Responsibilities
- Drive process optimization projects to maintain an environment of continuous improvement.
- Occasional travel to company or vendor sites as required.
Essential skills and knowledgeÂ
Requirements
- Minimum 10 years of experience in the GMP pharmaceutical industry with progressive quality assurance responsibilities.
- Bachelor of Science degree (or Canadian equivalent).
- Proven leadership experience managing large, cross-functional teams.
- Demonstrated success leading Health Canada inspections and client audits.
- Experience overseeing warehouse storage, distribution, and transportation logistics.
- Strong knowledge of GMP, GVP, Medical Device, and Natural Health Product regulations.
- Excellent communication, negotiation, and stakeholder management skills.
- Business acumen and a risk-based approach to decision-making.
- Quality Auditor certification and experience considered an asset.
- Familiarity with Patient Support Programs (PSPs) is an asset.
Additional Skills
- Strong analytical and problem-solving skills.
- Adaptable and able to prioritize in dynamic environments.
- Skilled in resolving complex situations with professionalism and tact.
- Ability to balance quality and patient safety with business goals.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Excellent written and verbal communication skills.
What we offer
What We Offer
Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We'll get you going while you get on with the job.
About Us
Brunel has a reputation for working with some of the best in the business. That's what we continually strive for. Over 45 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.