QA Manager Documentation Review - Onsite Mississauga

Mississauga, Canada💼 Full-time💰 $85,500–$85,500🗓 2026-08-21 → 2026-09-30

Core

Lead QA teams responsible for GMP production documentation review, laboratory data review, and batch disposition to ensure compliance and data integrity.

Role type

Manager, Quality Assurance (Production Documentation & Lab Data Review)

Builds

Compliant pharmaceutical production batches and validated laboratory data

Domain

Pharmaceutical Development Services (PDS) and Commercial operations

Required skills

GMP documentation review, laboratory data review, batch disposition, team leadership, regulatory compliance (FDA/Health Canada/ICH/EMA), data integrity (ALCOA+), quality systems (deviations/CAPA/change control), trend analysis, electronic records management

Preferred skills

Six Sigma certification, knowledge of OOS/OOT investigations, experience with TrackWise/LIMS/Empower/SAP/MES

Technologies

TrackWise, LIMS, Empower, SAP, MES

Responsibilities

Lead and develop multiple documentation and lab data review teams; oversee timely review and approval of batch records and lab data; monitor performance metrics and review queues; support regulatory inspections and audits; develop procedures and training materials; escalate compliance risks

Seniority

Manager, hands-on leadership

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About thermofisher

Here at Thermo Fisher Scientific, our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research, clinical to commercial production means you can have a broad and significant impact. All while working in an environment where you will be supported, valued and rewarded for your performance. Join our Sales & Marketing team with an unmatched depth of capabilities and help our customers solve some of the world’s toughest challenges.