Che(fe) Assurance Qualité Produit
Core
Plan, organize, and supervise product quality assurance activities linked to manufacturing to ensure regulatory compliance, product integrity, and process robustness in a highly structured pharmaceutical environment.
Role type
Senior Quality Assurance Product Manager (Pharmaceutical Manufacturing)
Builds
Pharmaceutical products (finished goods, raw materials, packaging) compliant with regulatory standards
Domain
Pharmaceutical manufacturing (sterile environment)
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Batch release management, regulatory compliance (GMP/BPF), CAPA management, change control, complaint handling, process validation, sterile environment operations, team leadership, resource planning
Preferred skills
Speq system knowledge, Quality Assurance certification, process validation principles, Order of Chemists of Quebec membership
Responsibilities
Ensure product quality activities comply with current standards and procedures (BPF), 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, Follow up on 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