Regulatory & Quality Digital Transformation Consultant

Mivado GlobalPerformance Inc; Quebec; On-site; CAD 75,000 - 100,000; Full time

Job summary

A life sciences consulting firm is seeking a Regulatory & Quality Compliance Consultant to guide clients through digital transformation initiatives. This role involves interpreting regulatory requirements, advising on best practices, and ensuring compliance during audits. The ideal candidate has a background in pharma or biotech operations, a relevant degree, and is skilled in QMS and LIMS. Strong communication and problem-solving abilities are essential. This position offers a chance to impact quality and manufacturing processes significantly.

Qualifications

• 5+ years in pharma/biotech operations, QA, QC, manufacturing, or regulatory affairs.
• Hands‑on experience with QMS, LIMS, MES, or other GxP systems is highly preferred.
• Strong understanding of GxP processes and digitalization trends.

Responsibilities

• Interpret and explain regulatory requirements (GMP, GAMP 5, 21 CFR Part 11).
• Advise clients on best practices for digitalizing quality and manufacturing processes.
• Ensure documentation aligns with regulatory expectations and internal quality standards.
• Lead workshops with QA, QC, Manufacturing, and Regulatory teams.

Skills

Pharma operations

Quality Assurance (QA)

Quality Control (QC)

Regulatory affairs

Digital transformation

Communication

Analytical thinking

Problem-solving

Education

Bachelor's or Master’s degree in Pharmacy, Biotechnology, Chemistry, Life Sciences

Tools

QMS

LIMS

MES

Job description

A life sciences consulting firm is seeking a Regulatory & Quality Compliance Consultant to guide clients through digital transformation initiatives. This role involves interpreting regulatory requirements, advising on best practices, and ensuring compliance during audits. The ideal candidate has a background in pharma or biotech operations, a relevant degree, and is skilled in QMS and LIMS. Strong communication and problem-solving abilities are essential. This position offers a chance to impact quality and manufacturing processes significantly.