SEPTODONT - Quality Control Manager - Chemistry
Global - Legal entities
Publiée le
21/04/2026
Contrat
CDI
Localisation
25 Wolseley Court N1R 6X3 Cambridge
Taille équipe
2000+ emp.
Rémunération
Inconnue
Missions clés
Diriger les opérations de contrôle qualité en chimie. · Assurer la conformité et la préparation aux inspections. · Gérer une équipe d'analystes pour garantir la productivité et la qualité. · Mettre en œuvre des initiatives d'amélioration continue. · Gérer les budgets et les coûts d'exploitation du laboratoire de chimie.
Profil recherché
Bac +3 (Licence, Bachelor) · 5-10 ans d'expérience · Leadership · Communication · Résolution de conflits · Gestion du temps
Outils & compétences
Gestion de la qualité, Contrôle qualité, Méthodes analytiques, Validation de méthodes, Gestion de projet, Conformité GMP, Analyse de données, Gestion des risques
Le poste en détail
Engage with Pharma CDMO leadership, project teams, and clients to deliver compliant, predictable, and high-quality QC Chemistry support.Support highly variable client programs through analytical strategy execution, method validation, and lifecycle management aligned to regulatory expectations.Lead QC Chemistry support for technical transfers, product introductions, and scale-up activities to meet client timelines.Ensure inspection readiness and effective support for client and regulatory audits supporting CDMO programs.Identify and mitigate risks to client programs to protect data integrity, quality, and supply continuity.Drive continuous improvement initiatives that enhance client satisfaction, efficiency, and regulatory compliance.Lead QC Chemistry laboratory operations to ensure compliant, timely, and reliable testing of raw materials, components, in-process, and finished products.Ensure laboratory activities meet GMP, regulatory, and data integrity requirements through effective systems, controls, and oversight.Allocate resources and strategically prioritize work to meet operational commitments, business timelines, and client expectations and shifting conditions.Build and sustain a high-performing QC Chemistry team through hiring, onboarding, training, coaching, and performance management.Implement employee relations activities, including performance improvement, corrective actions, and conflict resolution, in partnership with Human Resources.Oversees the performance and development of all direct reports, partnering with Human Resources to conduct performance reviews, implement performance improvement and corrective action plans, manage disciplinary actions, and resolve employee relations matters, including conflict resolution.Ensure staffing coverage across shifts to maintain operational continuity and business support.Lead and provide subject-matter expertise for quality investigations, including deviations, OOS, and complaints, ensuring thorough root cause analysis and effective CAPA.Drive QC Chemistry change management, including authorship, review, and governance of SOPs and controlled documents.Support internal, client, and regulatory inspections through audit readiness and direct participation.Support analytical method transfer, validation, verification, and lifecycle management activities.Analyze quality performance data and trends; communicate risks, insights, and improvement recommendations to leadership and stakeholders.Partner cross-functionally to support investigations, continuous improvement initiatives, and operational excellence.Manages budgets and Chemistry laboratory operating costs by forecasting requirements.