Chef(fe) Assurance Qualité
Core
Ensure product quality compliance with manufacturing operations and regulatory standards in a highly structured pharmaceutical environment.
Role type
Senior Quality Assurance Product Manager
Builds
Pharmaceutical products ensuring regulatory compliance and process robustness
Domain
Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Batch release management, Master formula/specification approval, Quality investigation leadership, CAPA/change control management, Customer/complaint handling, Regulatory audit participation, Corrective action tracking, Sterile environment operations, Team supervision, Regulatory monitoring
Preferred skills
Order of Chemists of Quebec membership, Speq system knowledge, Quality certification, Process validation principles
Responsibilities
Ensure product quality activities comply with current standards and procedures (GMP). Release batches (raw materials, packaging, finished products). Approve manufacturing certificates, specifications, and master formulas. Supervise investigations related to quality events. Review and approve CAPAs, PONs, and change controls. Manage customer and supplier complaints. Review manufacturing files and sampling activities. Approve process and cleaning validations. Participate in internal audits and regulatory inspections. Track corrective actions from audits. Maintain regulatory awareness. Define and track departmental objectives. Plan activities to optimize resources. Lead, mobilize, and develop team members. Collaborate with clients, suppliers, and partners.
Seniority
Senior, hands-on IC with team leadership
