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R&D Quality Assurance Associate - Job Opportunity at Biolab Pharma Ltd

Mississauga, Canada
Full-time
Mid-level
Posted: June 19, 2025
On-site
CAD 65,000 - 85,000 annually based on mid-level pharmaceutical QA roles in the Greater Toronto Area market, with potential for higher compensation given the specialized regulatory knowledge requirements and bilingual Canadian market demands

Benefits

Professional casual dress code promoting comfort and work-life balance in laboratory settings
Comprehensive dental coverage ensuring oral health maintenance for healthcare professionals
Employee assistance program providing mental health and wellness support critical for high-stress pharmaceutical environments
Extended health care benefits covering medical expenses beyond provincial coverage
Flexible scheduling accommodating the demands of R&D project timelines and work-life integration
Convenient on-site parking eliminating commute stress and transportation costs
Vision care benefits essential for professionals working extensively with documentation and analytical data

Key Responsibilities

Lead the strategic development of Biolab's Canadian R&D quality management system, establishing foundational compliance infrastructure
Drive implementation of comprehensive compliance frameworks across R&D operations, ensuring alignment with international regulatory standards including cGMP, GLP, and GCP
Execute strategic self-inspection audits and lead regulatory compliance assessments, directly impacting company's ability to maintain market authorization
Orchestrate and lead multi-stakeholder audits with regulatory agencies, serving as primary quality representative for critical business operations
Direct incident investigation processes during product development phases, making decisions that affect product safety and market viability
Authorize and approve critical regulatory documentation for global submissions, including analytical reports, stability data, and clinical study documentation
Ensure enterprise-wide adherence to quality standards across formulation and analytical development teams, safeguarding product integrity and regulatory compliance
Generate strategic data analysis and present findings to senior management, influencing key business decisions and development priorities

Requirements

Education

Canadian equivalent to Master of Science, PhD or Bachelor of Science degree, preferably in Pharmacy, Chemistry or Pharmaceutical Chemistry

Experience

More than two years of relevant hands on pharmaceutical Quality Assurance experience in product development

Required Skills

Strong knowledge and experience of quality management systems in product development, clinical research and pharmacovigilance Ability to work independently or as a part of a team, and to coach less experienced colleagues Skills to handle multiple projects and prioritize the work Excellent communication skills (oral and written) and interpersonal skills

Certifications

Diploma/Degree/Certificate in Quality Assurance is preferred
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented regulatory scrutiny following recent global health events, creating elevated demand for quality assurance professionals who can navigate complex international compliance requirements across multiple jurisdictions including FDA, EMEA, Health Canada, and ANVISA. Digital transformation in pharmaceutical R&D is driving need for QA professionals who can manage hybrid documentation systems and electronic submissions while maintaining traditional GMP compliance, representing a critical skill gap in the market. Increased focus on personalized medicine and complex drug delivery systems is creating demand for QA associates with experience in novel analytical methods and validation protocols for non-traditional pharmaceutical products.

Role Significance

Typically manages quality oversight for 8-15 R&D team members across analytical and formulation development teams, while collaborating with cross-functional teams including regulatory affairs, clinical operations, and manufacturing
Mid-level professional role with significant autonomous decision-making authority over regulatory compliance and product approval processes, positioned as a subject matter expert within the R&D organization with direct impact on product commercialization timelines

Key Projects

Leading validation protocols for new analytical methods supporting novel drug development programs Managing quality aspects of international regulatory submissions for market authorization in multiple jurisdictions Implementing risk-based quality management systems for complex pharmaceutical development programs Overseeing technology transfer activities from development to commercial manufacturing

Success Factors

Deep understanding of international pharmaceutical regulations and ability to interpret complex guidance documents across multiple regulatory agencies Strong project management capabilities to coordinate quality activities across multiple development programs simultaneously Excellent communication skills to serve as quality liaison between internal teams and external regulatory bodies Analytical mindset to assess compliance risks and develop mitigation strategies that balance regulatory requirements with business objectives Leadership abilities to influence cross-functional teams and drive quality culture throughout the R&D organization

Market Demand

High demand driven by Canada's growing pharmaceutical manufacturing sector, increased regulatory complexity, and the critical shortage of experienced QA professionals capable of managing multi-jurisdictional compliance requirements

Important Skills

Critical Skills

International regulatory knowledge across multiple agencies (FDA, EMEA, Health Canada, ANVISA) is essential as pharmaceutical companies increasingly require professionals capable of managing global compliance strategies and understanding nuanced regulatory differences between markets. Risk assessment and management capabilities are crucial in today's pharmaceutical environment where quality failures can result in significant financial penalties, product recalls, and damage to company reputation, making this skill highly valued by employers. Technical documentation and regulatory writing skills are fundamental as the role involves creating and reviewing complex scientific documents that directly impact product approval timelines and commercial success.

Beneficial Skills

Project management certification and experience would enhance effectiveness in coordinating multiple development programs and cross-functional teams in matrix organizations. Digital systems proficiency including electronic document management systems and data integrity protocols is increasingly important as the industry transitions to paperless operations. Clinical research knowledge and GCP expertise would provide additional value given the company's involvement in clinical supplies and potential clinical development activities.

Unique Aspects

Multi-jurisdictional regulatory focus requiring expertise in Canadian, US, European, and Brazilian regulatory frameworks, providing valuable international experience
Direct involvement in product development from early stages through commercial launch, offering comprehensive pharmaceutical development experience
Opportunity to establish and build quality management systems, providing leadership experience in system implementation
Close collaboration with analytical and formulation development teams, creating cross-functional expertise valuable for career advancement

Career Growth

3-5 years to senior management roles given the specialized nature of pharmaceutical QA and the high demand for experienced professionals in the Canadian market

Potential Next Roles

Senior QA Manager overseeing multiple therapeutic areas and larger teams Regulatory Affairs Manager focusing on submission strategy and agency interactions Quality Systems Director responsible for enterprise-wide quality management Technical Documentation Manager leading regulatory writing and submission teams

Company Overview

Biolab Pharma Ltd

Biolab Pharma Ltd operates as a pharmaceutical development and manufacturing company with focus on generic and specialty pharmaceutical products, serving both domestic Canadian and international markets through product development and contract manufacturing services.

Mid-tier pharmaceutical company positioned in the competitive Canadian generic pharmaceutical market, with established regulatory relationships and proven track record of successful product launches across multiple therapeutic areas
Strategic location in Mississauga positions the company within Canada's pharmaceutical corridor, providing access to regulatory agencies, clinical research organizations, and key industry partnerships while serving as a hub for North American operations
Traditional pharmaceutical industry culture emphasizing regulatory compliance, scientific rigor, and collaborative teamwork, with structured processes and clear accountability frameworks typical of regulated manufacturing environments
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