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Associate, Quality Assurance & Compliance - Job Opportunity at Formative Pharma Inc.

Burlington, Canada
Full-time
Mid-level
Posted: June 17, 2025
Hybrid
Based on the mid-level requirements, Canadian pharmaceutical industry standards, and Burlington location, this role likely offers CAD 70,000-85,000 annually. The competitive compensation package mentioned suggests positioning at or above market median, potentially reaching CAD 90,000 with the comprehensive benefits package.

Benefits

Competitive compensation package with industry-leading salaries reviewed annually, positioning employees above market standards
Comprehensive work-life balance support including flexible work hours and compressed work weeks, addressing modern workforce needs
Employee health and wellness investment programs, demonstrating long-term employee care
People-first culture with rewards and recognition initiatives that celebrate team accomplishments
Quarterly in-person gatherings and events fostering team cohesion and company culture
Values-driven work environment focused on patient outcomes, providing meaningful career purpose

Key Responsibilities

Lead contract laboratory operations by initiating, reviewing, and managing method transfer protocols and reports, directly impacting product quality and regulatory compliance
Drive strategic testing activities management including scheduling and reference standard maintenance, ensuring operational efficiency and regulatory adherence
Oversee comprehensive stability program management through data review and follow-ups, critical for product lifecycle management and market authorization
Execute quality systems governance by processing Change Controls, Deviations, and CAPAs, maintaining regulatory compliance and operational excellence
Develop and maintain Standard Operating Procedures, establishing organizational knowledge base and ensuring consistent operational standards
Manage master document storage and archival systems, ensuring regulatory compliance and operational continuity
Lead employee training initiatives and maintain training databases, building organizational capability and regulatory compliance
Create and revise product specifications, directly impacting product quality and regulatory approval processes
Conduct quality data analysis and trend reporting, providing strategic insights for continuous improvement
Prepare Annual Product Quality Review reports, ensuring regulatory compliance and demonstrating product quality oversight
Manage customer complaints and inquiry tracking systems, maintaining market reputation and regulatory compliance
Support regulatory inspections and licensing activities, ensuring continued market authorization and business continuity

Requirements

Education

Minimum bachelor's degree in Science (Chemistry or Life Sciences) or equivalent experience

Experience

Minimum of 3 years of practical experience in the pharmaceutical industry in the areas of QA and/or QC

Required Skills

Laboratory experience preferred Experience with sterile drug products preferred Computer systems validation experience an asset Practical knowledge of a pharmaceutical quality systems environment (i.e., Change Control, Deviations, CAPA, SOP's, etc.) Practical experience with Good Documentation Practices, investigational techniques, and executing Canadian GMP requirements Independent, self-motivated individual with well-developed organizational and planning skills Ability to work with shifting priorities and multiple projects Excellent oral and written communication skills (in English) Team-first mentality Strong computer skills i.e. MSOffice: Word, Excel, PowerPoint
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing increased regulatory scrutiny and compliance requirements, particularly in quality assurance, driven by recent global supply chain disruptions and heightened focus on drug safety. This trend is creating sustained demand for QA professionals who can navigate complex regulatory environments and ensure product integrity across multiple jurisdictions. Canadian pharmaceutical companies are expanding their domestic manufacturing capabilities as part of national security initiatives, leading to increased investment in quality systems and compliance infrastructure. This represents a significant growth opportunity for QA professionals with Canadian GMP expertise. Digital transformation in pharmaceutical quality management is accelerating, with companies implementing advanced data analytics, electronic quality management systems, and automated compliance monitoring. Professionals with both traditional QA knowledge and digital system experience are particularly valuable in this evolving landscape.

Role Significance

Typically operates within a quality team of 5-10 professionals, collaborating closely with regulatory affairs, operations, and external partners. The role involves training responsibilities, suggesting potential for team leadership development.
This is a mid-level professional role with significant operational responsibility and regulatory impact. The associate reports to senior management but operates with considerable autonomy in managing critical quality processes, indicating a position that bridges operational execution with strategic oversight.

Key Projects

Annual product quality reviews and regulatory submissions Method transfer and validation projects for new products Quality system implementations and improvements Regulatory inspection preparation and response Supplier qualification and ongoing monitoring programs

Success Factors

Deep understanding of Canadian regulatory landscape and GMP requirements, as regulatory compliance directly impacts business operations and market access Strong analytical and problem-solving capabilities to investigate quality issues and implement effective corrective actions Excellent project management skills to handle multiple concurrent quality initiatives while maintaining regulatory timelines Effective communication abilities to interface with regulatory authorities, suppliers, and internal stakeholders Continuous learning mindset to stay current with evolving regulations and industry best practices

Market Demand

High demand driven by regulatory complexity, industry growth, and specialized skill requirements. The combination of Canadian GMP expertise, sterile products experience, and quality systems knowledge creates a favorable candidate market with strong job security.

Important Skills

Critical Skills

Canadian GMP expertise is essential as it directly enables regulatory compliance and market access, representing the core competency that differentiates this role from general pharmaceutical QA positions Quality systems knowledge including Change Control, CAPA, and deviation management forms the operational foundation for maintaining regulatory compliance and operational excellence Documentation and communication skills are critical for regulatory interactions, inspection readiness, and cross-functional collaboration in a regulated industry environment

Beneficial Skills

Sterile products experience enhances career mobility within high-value pharmaceutical segments and provides specialized expertise that commands premium compensation Computer systems validation knowledge positions professionals for digital transformation initiatives and advanced quality management system implementations Laboratory experience provides technical credibility and enables more effective oversight of analytical testing and method validation activities

Unique Aspects

Combination of pharmaceutical and medical device expertise providing diverse regulatory experience and broader industry knowledge than single-focus companies
Strong emphasis on Canadian GMP requirements and domestic market focus, offering specialized expertise in Canadian regulatory landscape
Growth-stage company environment providing opportunities for process development and system implementation rather than just maintenance of established procedures
Patient-outcome focused mission providing meaningful work context and alignment with healthcare improvement goals

Career Growth

Progression to senior specialist level typically occurs within 2-3 years, with management opportunities available within 4-5 years based on performance and organizational growth.

Potential Next Roles

Senior Quality Assurance Specialist with expanded regulatory oversight Quality Assurance Manager leading a functional team Regulatory Affairs Associate focusing on submissions and agency interactions Quality Systems Lead specializing in digital transformation initiatives

Company Overview

Formative Pharma Inc.

Formative Pharma Inc. operates as a Canadian-owned specialty pharmaceutical and medical device company with a focus on innovative patient care solutions. The company appears to be in a growth phase, emphasizing Canadian market development and regulatory compliance excellence.

Mid-tier specialty pharmaceutical company with strong Canadian market focus and commitment to innovation. The emphasis on Canadian ownership and market specialization suggests a strategic positioning in the domestic healthcare landscape.
Strong Canadian presence with Burlington operations indicating proximity to major pharmaceutical manufacturing hubs and regulatory centers. The location provides access to both Canadian and potential US market opportunities.
Values-driven organization emphasizing work-life balance, employee development, and patient-focused mission. The hybrid work model and emphasis on people-first culture suggests a modern, flexible workplace that prioritizes employee satisfaction alongside business objectives.
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