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Jubilant Pharma Limited

Gestionnaire, Opérations Qualité et Projets / Manager, QA Operations & Projects

Montreal, QC, Canada

Job type: Full-time
Apply by: Oct 30, 2026
Posting language: English · French
Posted: Sep 30, 2026

Apply About employer

Applications open in a new tab.

Original job description

English section of this bilingual listing.

At Jubilant Radiopharma, we support patient care through the manufacturing and delivery of high-quality radiopharmaceutical products. We are committed to quality, innovation, and continuous improvement while fostering a collaborative and inclusive workplace.

We are seeking a skilled and people-focused Manager, QA Operations & Projects to join our team.

Role Overview

Reporting to Quality Assurance leadership, the Manager, QA Operations & Projects leads the QA Operations team, oversees the Investigation Program, and serves as the Quality representative for strategic facility expansion and capital projects. This role is instrumental in maintaining regulatory compliance, supporting manufacturing operations, and driving continuous improvement initiatives.

Key Responsibilities

Lead, coach, and develop QA Operations Specialists.
Provide active quality support to manufacturing operations and resolve quality issues in real time.
Review and approve operational quality documentation.
Promote compliance with GMPs, internal procedures, and quality standards.
Manage the Investigation Program to ensure robust root cause analyses and complete documentation.
Review and approve internal and external investigations while ensuring data integrity and traceability.
Define, monitor, and communicate quality performance indicators.
Perform trend analyses and recommend preventive and corrective actions.
Support regulatory inspections and external audits.
Identify and lead continuous improvement initiatives.
Serve as the Quality representative for facility expansion, renovation, and capital projects.
Partner with engineering, validation, and project management teams to integrate quality and regulatory requirements throughout project lifecycles.
Support talent acquisition, onboarding, and employee development initiatives.
Perform other duties as assigned by management.

Qualifications

Bachelor's degree in Science, Engineering, or a related discipline.
Minimum 7 to 10 years of Quality Assurance experience in a regulated pharmaceutical, biopharmaceutical, or medical device environment.
Demonstrated experience leading, supervising, or developing teams.
Experience in investigation management, root cause analysis, and continuous improvement.
Experience supporting facility expansion projects, equipment qualification, commissioning, or GMP validation activities is considered an asset.
Experience supporting regulatory inspections (FDA, Health Canada, ANSM, EMA, or equivalent).
In-depth knowledge of GMP regulations in Canada, the United States, and Europe..
Strong understanding of root cause analysis and problem-solving methodologies.
Knowledge of project management principles within a GMP environment.
Proficiency with Microsoft Office and SAP environments.
Bilingual in French and English. Proficiency in English is essential as the role interacts with regulatory agencies located outside Quebec.
Excellent communication, leadership, collaboration, and prioritization skills and ability to influence cross-functional teams without direct authority.

Read the full bilingual original

Joignez-vous à Jubilant Radiopharma

Chez Jubilant Radiopharma, nous contribuons chaque jour à soutenir les soins aux patients grâce à la fabrication et à la distribution de produits radiopharmaceutiques de haute qualité. Nous favorisons un environnement collaboratif où l'innovation, la qualité et l'amélioration continue sont au c?ur de nos actions.

Nous sommes à la recherche d'une personne engagée et mobilisatrice pour se joindre à notre équipe à titre de Gestionnaire, Opérations Qualité et Projets.

Aperçu du rôle

Relevant de la direction de l'Assurance qualité, la personne titulaire du poste dirige l'équipe des opérations qualité, assure la gestion du programme d'investigations qualité et agit comme représentant qualité pour les projets stratégiques d'expansion et d'amélioration des installations. Ce rôle joue un rôle clé dans le maintien de la conformité réglementaire, le soutien aux opérations manufacturières et l'amélioration continue de nos processus.

Responsabilités principales

Diriger, encadrer et développer l'équipe des spécialistes QA Ops.
Assurer une présence qualité active dans les opérations manufacturières afin de soutenir la production et résoudre les enjeux qualité.
Réviser et approuver la documentation qualité liée aux opérations.
Promouvoir le respect des BPF, des procédures internes et des normes qualité.
Gérer le programme d'investigations afin d'assurer des analyses robustes des causes racines et des dossiers complets.
Réviser et approuver les investigations internes et externes tout en assurant la qualité de la documentation et la traçabilité.
Définir, suivre et communiquer les indicateurs de performance qualité.
Réaliser des analyses de tendances et recommander des mesures préventives ou correctives.
Soutenir les inspections réglementaires et les audits.
Identifier et piloter des initiatives d'amélioration continue.
Représenter la Qualité dans les projets d'expansion, de rénovation et d'investissement.
Examiner et approuver les URS, documents de conception, protocoles de mise en service, protocoles de qualification et rapports de validation.
Collaborer avec les équipes d'ingénierie, de validation et de gestion de projets afin d'intégrer les exigences qualité et réglementaires tout au long du cycle de vie des projets.
Participer à l'embauche, à l'intégration et au développement des talents.
Effectuer toutes autres tâches confiées par la direction.

Qualifications

Baccalauréat en sciences, en ingénierie ou dans un domaine connexe.
Minimum de 7 à 10 années d'expérience en assurance qualité dans un environnement pharmaceutique, biopharmaceutique ou de dispositifs médicaux réglementé.
Expérience démontrée en supervision, gestion ou développement d'équipes.
Expérience en gestion d'investigations, en analyse des causes racines et en amélioration continue.
Une expérience liée à des projets d'expansion d'installations, à la qualification d'équipements ou à la validation d'installations GMP constitue un atout.
Expérience lors d'inspections réglementaires (FDA, Santé Canada, ANSM, EMA ou équivalent).
Connaissance approfondie des bonnes pratiques de fabrication (BPF) au Canada, aux États-Unis et en Europe.
Solides connaissances des méthodologies d'analyse des causes racines et de résolution de problèmes.
Compréhension des principes de gestion de projets dans un environnement GMP.
Maîtrise de Microsoft Office et expérience dans un environnement SAP.
Bilinguisme français-anglais. Une bonne maîtrise de l'anglais est essentielle puisque le rôle doit interagir avec des agences réglementaires situées à l'extérieur du Québec.
Excellentes aptitudes en communication, leadership, collaboration et gestion des priorités et forte capacité à exercer une influence positive auprès d'équipes multidisciplinaires.

ENGLISH

Join Jubilant Radiopharma

We are seeking a skilled and people-focused Manager, QA Operations & Projects to join our team.

Role Overview

Key Responsibilities

Lead, coach, and develop QA Operations Specialists.
Provide active quality support to manufacturing operations and resolve quality issues in real time.
Review and approve operational quality documentation.
Promote compliance with GMPs, internal procedures, and quality standards.
Manage the Investigation Program to ensure robust root cause analyses and complete documentation.
Review and approve internal and external investigations while ensuring data integrity and traceability.
Define, monitor, and communicate quality performance indicators.
Perform trend analyses and recommend preventive and corrective actions.
Support regulatory inspections and external audits.
Identify and lead continuous improvement initiatives.
Serve as the Quality representative for facility expansion, renovation, and capital projects.
Review and approve User Requirement Specifications (URS), design documents, commissioning protocols, qualification protocols, and validation reports.
Partner with engineering, validation, and project management teams to integrate quality and regulatory requirements throughout project lifecycles.
Support talent acquisition, onboarding, and employee development initiatives.
Perform other duties as assigned by management.

Qualifications

Bachelor's degree in Science, Engineering, or a related discipline.
Minimum 7 to 10 years of Quality Assurance experience in a regulated pharmaceutical, biopharmaceutical, or medical device environment.
Demonstrated experience leading, supervising, or developing teams.
Experience in investigation management, root cause analysis, and continuous improvement.
Experience supporting facility expansion projects, equipment qualification, commissioning, or GMP validation activities is considered an asset.
Experience supporting regulatory inspections (FDA, Health Canada, ANSM, EMA, or equivalent).
In-depth knowledge of GMP regulations in Canada, the United States, and Europe..
Strong understanding of root cause analysis and problem-solving methodologies.
Knowledge of project management principles within a GMP environment.
Proficiency with Microsoft Office and SAP environments.
Bilingual in French and English. Proficiency in English is essential as the role interacts with regulatory agencies located outside Quebec.
Excellent communication, leadership, collaboration, and prioritization skills and ability to influence cross-functional teams without direct authority.

Apply About employer

More about this job

Responsibilities

Lead and develop the QA Operations team, oversee quality investigations, support manufacturing operations, and maintain GMP and regulatory compliance. Represent Quality on facility expansion and capital projects, review project and validation documentation, and drive performance monitoring and continuous improvement.

Requirements

A bachelor's degree in science, engineering, or a related field and 7–10 years of Quality Assurance experience in a regulated pharmaceutical, biopharmaceutical, or medical device environment are required. Candidates should have team leadership and investigation experience, strong GMP and root cause analysis knowledge, and be bilingual in French and English; facility project experience and SAP proficiency are also relevant.

Skills

Quality Assurance Operations
Team Leadership and Development
GMP Compliance
Investigation Management
Root Cause Analysis
Continuous Improvement
Quality Documentation Review
Quality Performance Indicators
Trend Analysis
Regulatory Inspections and Audits
Facility Expansion Projects
Equipment Qualification
Commissioning and Validation
Project Management in GMP Environments
SAP
French-English Bilingual Communication

Visa sponsorship

Not detected in the job text

Keywords

Quality Assurance
QA Operations
Good Manufacturing Practices
Pharmaceutical Manufacturing
Radiopharmaceuticals
Regulatory Compliance
Quality Investigations
Root Cause Analysis
Corrective and Preventive Actions
Continuous Improvement
Quality Performance Indicators
Trend Analysis
Regulatory Inspections
External Audits
Facility Expansion
Capital Projects
Design Documents
Commissioning Protocols
Equipment Qualification
GMP Validation
Data Integrity
Traceability
Project Management
SAP
Microsoft Office
FDA
Health Canada
ANSM
EMA

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