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.
Anything else ?
Shape your future
Are you ready for the next step in your career? Join Brunel’s powerful global network, where passionate, results-driven specialists come together with industry-leading clients. By connecting specialists to pioneering projects, we drive change in many industries, enabling growth and delivering great outcomes. Brunel helps you reach your full potential and empowers you to make an impact within a purpose-driven global company.
Explore your career opportunities!
Explore your career opportunities!
Our Culture and Values
At Brunel, we are proud of our unique corporate culture, which is shaped and nurtured by the collective efforts of our employees. Our work environment is characterised by an authentic, communicative and inclusive approach to teamwork that fosters an atmosphere of collaboration and creativity. Our values are at the center of everything we do – for our clients, our colleagues and ourselves.
Learn more about our global network of specialists!
Learn more about our global network of specialists!
Our ESG Commitment
Since 1975, our mission has always been to connect specialists to exciting career opportunities, to support the development of these careers, and to offer fair and equal employment. This has enabled us to create a truly sustainable and durable business model. Having a passion for people and caring deeply for the environment is not only part of Brunel’s DNA but is also reflected in our culture and values. As a global company, we take our social responsibility very seriously.
Join us on our mission!
Join us on our mission!
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