Position OverviewPharma For You is seeking a highly accomplished, senior-level Regulatory and Quality Assurance Specialist to support client organizations on a flexible, project-based consulting basis. In this role, you will serve as a strategic leader and subject matter expert responsible for establishing, enhancing, and maintaining Good Manufacturing Practice (GMP) compliant quality management systems, leading regulatory submission workflows, and instilling a robust quality culture across diverse client ecosystems.

Key Responsibilities &

• Scope of Work

- GMP Quality Systems Architecture: Architect, implement, and audit GMP-compliant Quality Management Systems (QMS) tailored to client operational maturity, ensuring seamless alignment with Health Canada and FDA regulations across pharmaceuticals, natural health products, and medical devices.
- Regulatory Submissions & • Strategy:

Author, compile, review, and manage drug submissions, license applications, and regulatory filings; liaise directly with regulatory authorities to facilitate efficient review cycles and approvals.
- Standard Operating Procedures (SOPs): Draft, revise, and harmonize robust standard operating procedures, validation protocols, master manufacturing documents, and deviation handling systems.
- Qualification & • Validation Oversight:

Provide senior-level technical direction on equipment, process, facility, and analytical method qualification and validation protocols (IQ/OQ/PQ) ensuring regulatory compliance.
- Audit Readiness & • Inspections:

Plan and conduct comprehensive internal and mock audits to evaluate operational readiness; serve as the primary subject matter expert during regulatory and client third-party audits.
- Regulatory Reporting & • Documentation:

Prepare high-level audit summaries, annual product quality reviews (APQR), non-conformance reports, CAPA investigations,



and formal regulatory reports.
- Leadership & • Quality Culture:

Enter dynamic client environments (ranging from small startups to mid-sized teams), build immediate rapport, establish credibility, and guide cross-functional personnel toward adopting a proactive quality-first mindset.

Required Qualifications & • Credentials

- Advanced Education: Advanced graduate degree (Master of Science or Ph.D.) in Chemistry, Biochemistry, Pharmacology, Life Sciences, or a closely related scientific discipline is strongly preferred (minimum B.Sc. required with extensive senior industry experience).
- Industry Experience: Substantial hands-on experience directly within the pharmaceutical or biopharmaceutical manufacturing industry, specifically in Quality Assurance, Quality Systems, or Regulatory Affairs leadership roles.
- Regulatory Expertise: In-depth mastery of Health Canada Food and Drug Regulations, GMP guidelines (GUI-0001), FDA 21 CFR Parts 210/211/820, and ICH quality guidelines (Q7, Q8, Q9, Q10).
- Auditing Background: Demonstrated track record in leading or hosting formal regulatory inspections, supplier audits, and performing internal audit remediations.
- Interpersonal & • Client Communication:

Exceptional verbal and written communication skills with the proven ability to present complex technical and regulatory requirements clearly to client executive leadership and operational staff.
- Influence & • Change Management:

Proven aptitude for guiding teams through operational transitions, implementing new standards, and inspiring diverse stakeholders without formal hierarchical authority.

Engagement Terms & • Working Conditions

- Model: Project-based independent consulting engagement offering flexible hours tied to project deliverables and client milestones.
- Location: Primarily remote work with required periodic travel to client manufacturing or laboratory facilities across Canada.

📌 Senior Regulatory and Quality Specialist (Toronto)
🏢 PHARMA 4U
📍 Toronto