Job Description

Jubilant HollisterStier, une filiale de Jubilant Pharma Holdings Inc., recrute actuellement un(e)

Chef / Chef principal, operations qualite

pour rejoindre notre equipe!

Ce que nous offrons

Une culture qui valorise la croissance ainsi que les opportunites de developpement professionnel, un salaire de base hautement competitif, des regimes complets d'assurance medicale, dentaire et d'invalidite, un regime de retraite collectif, ainsi que des programmes de sante et de bien-etre.


Jubilant HollisterStier est une entreprise en forte croissance, avec des bureaux a Kirkland (Quebec) et a Spokane (Washington). En tant qu'organisation de fabrication sous contrat entierement integree, Jubilant HollisterStier a la capacite de produire des formulations injectables steriles, ainsi que des formes posologiques solides et semi-solides.


Nos quatre installations situees en Amerique du Nord et en Inde offrent des services de fabrication specialises pour les secteurs pharmaceutique et biopharmaceutique. Jubilant HollisterStier fait fierement partie de la famille Jubilant Pharma.

Pour plus d'informations, visitez : www.jublhs.com


Nous continuerons, avec le plus grand respect pour l'environnement et la societe, a creer de la valeur pour nos clients et nos partenaires en offrant des

p

roduits innovants et des solutions rentables, grace a la croissance, la rentabilite et une utilisation prudente des ressources.


Si vous etes pret(e) a relever un defi stimulant, nous vous invitons a franchir la premiere etape et a postuler des aujourd'hui!


Jubilant Pharma Holdings Inc. et toutes ses filiales sont fieres de la diversitede leur personnel.

Notre objectif est d'avoir une main-d'?uvre aussi diversifieeque les patients et clients que nous servons.

Nous favorisons un environnement inclusif

,

ou nos employes peuvent s'epanouir et ou nos differences sont valorisees.

En accueillant nos differences, nous creons des produits qui profitent a nos patients, a nos clients et a la sante humaine en general.

Objectif du poste

Le/la

Chef / Chef principal, operations qualite -

Supervision du plancher de fabrication est responsable d'assurer l'assurance qualite en temps reel et la conformite durant les operations de production. Ce role implique une surveillance directe des procedes aseptiques, des pratiques documentaires et des mesures de controle des contaminations sur le plancher de production. Le/la manager encadre une equipe de reviseurs qualite et d'experts (SMEs) afin de maintenir les normes BPF et les exigences reglementaires (HPFBI, FDA, UE, etc.) et repondre aux standards internes de Jubilant HollisterStier. Il/Elle assure la supervision qualite des activites de fabrication et d'emballage.

Responsabilites

Supervision operationnelle

Superviser en temps reel les interventions aseptiques de Niveau A afin de garantir le respect des POP et des BPF Identifier et documenter les ecarts par rapport aux exigences, et initier les actions correctives Reviser et mettre a jour en temps reel les dossiers de lots maitres (MMBR) pour garantir exactitude et conformite Superviser les procedures d'habillage et l'acces aux zones aseptiques selon les protocoles de salle blanche

Formation & expertise technique

Intervenir comme expert technique (SME) et formateur en pratiques aseptiques et controle des contaminations Soutenir le developpement et la mise en ?uvre des formations BPF pour le personnel de production

Conformite & documentation

Verifier et approuver la documentation BPF, y compris enquetes d'ecarts, CAPA et rapports de plaintes Garantir la resolution rapide des incidents qualite et une documentation conforme aux exigences reglementaires Soutenir les etudes de visualisation des flux d'air (smoke studies) et assurer une supervision qualite lors de leur execution

Gestion d'equipe & developpement

Recruter, former et encadrer le personnel QA pour assurer une performance elevee et conforme aux normes reglementaires Realiser les evaluations de performance et soutenir le developpement de carriere des collaborateurs directs Collaborer avec les equipes transversales pour identifier et mettre en ?uvre des initiatives d'amelioration continue

Responsabilites generales

Verifier et approuver les documents qualite lies aux systemes de qualite (rapports d'investigation, plaintes, etc.) Recruter et former le personnel pour toutes les fonctions des operations qualite Veiller a l'application des reglementations des agences et des procedures internes sur le site Assurer le maintien et la conformite des procedures de formation sur site et du programme de formation BPF Reviser periodiquement la performance des subordonnes selon les objectifs et indicateurs cles Informer le Directeur des Operations Qualite et le Directeur du Site de l'impact des legislations sur les fonctions du site, analyser les donnees pour identifier des opportunites d'amelioration et elaborer des plans avec differents responsables de service Agir comme representant qualite pour repondre aux questions et preoccupations des clients au nom de JHS Montreal Executer d'autres taches assignees par la Direction Leader une equipe de reviseurs QA integree aux operations de production pour prise de decision et resolution en temps reel Fournir des retours immediats et des conseils aux operateurs sur les techniques aseptiques et la maitrise de contamination

Interfaces externes

Agences reglementaires Clients

Interfaces internes

Tous les employes et responsables de tous les departements

Formation

Diplome requis (plus eleve)

:

BSc en sciences de la vie ou equivalent experience pertinente

Experience requise

5 a 10 ans d'experience dans l'industrie pharmaceutique

Experience supplementaire souhaitee

Solide experience des normes reglementaires & BPF associees au controle et validation des procedes, fabrication, conditionnement, tests, avec connaissance approfondie des reglementations canadiennes, americaines et europeennes Minimum 5 ans d'experience en gestion de personnel, souhaite

Competences requises

Maitrise des procedes aseptiques et des processus pharmaceutiques Expertise en investigations et analyse approfondie des causes racines Excellentes competences en communication ecrite et orale Maitrise des outils informatiques (Suite Office & environnement SAP) Bilinguisme (francais & anglais) Aptitude a resoudre les problemes et a trouver des solutions Ouverture d'esprit, curiosite, rigueur Leadership avere Solides competences interpersonnelles et organisationnelles

Environnement de travail

Physique

Aucun exigence physique particuliere pour ce poste

Environnemental

Travail dans des zones a risques quotidiens, sans exigences specifiques de securite

Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting a

Manager / Sr. Manager, Quality Operations

to join our team!

What do we offer?

A culture that values growth and professional development opportunities, a highly competitive base salary, comprehensive medical, dental, and disability insurance programs, a group retirement plan, as well as health and wellness programs. Jubilant HollisterStier is a rapidly growing company with offices in Kirkland, Quebec, and Spokane, Washington. As a fully integrated contract manufacturing organization, Jubilant HollisterStier has the capability to manufacture sterile injectable formulations, as well as solid and semi-solid dosage forms. Our four facilities in North America and India provide specialized manufacturing services for the pharmaceutical and biopharmaceutical sectors. Jubilant HollisterStier proudly belongs to the Jubilant Pharma family. For more information, visit www.jublhs.com.


We will continue, with the greatest care for the environment and society, to create value for our customers and stakeholders by offering innovative products and cost-effective solutions through growth, profitability, and prudent resource investment. If you're ready for a rewarding challenge, we invite you to take the first step and apply today!


Jubilant Pharma Holdings Inc. and all our subsidiaries are proud of the diversity of our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We have an inclusive environment where our employees can thrive, and where our differences are welcomed. By embracing our differences, we create products that benefit our patients, clients, and human health in general.

Job Objective:

The Manager / Sr. Manager, Quality Operations - Manufacturing Floor Oversight is responsible for ensuring real-time quality assurance and compliance during manufacturing operations. This role provides direct oversight of aseptic processing, documentation practices, and contamination control measures on the production floor. The manager leads a team of QA reviewers and SMEs to uphold GMP standards and regulatory requirements (HPFBI, FDA, EU, etc.) and meet the internal standards of Jubilant Hollisterstier. Provide quality oversight of manufacturing and packaging activities.

Assures the overall compliance of the site by ensuring procedures, processes and activities are implemented that meet the standards of the regulatory agencies Responsible for the compliance of the site GMP training program

Responsibilities:

Operational Oversight

Monitor Grade A aseptic interventions in real time to ensure strict adherence to SOPs and GMP. Identify and document deviations from procedural requirements and initiate corrective actions. Conduct real-time reviews and updates of Master Batch Manufacturing Records (MMBRs) to ensure accuracy and compliance.

Oversee gowning procedures and aseptic area access to ensure compliance with cleanroom protocols.

Training & Subject Matter Expertise

Serve as a subject matter expert (SME) and trainer in aseptic practices and contamination control. Support the development and delivery of GMP training programs for manufacturing personnel.

Compliance & Documentation

Review and approve GMP documentation including deviation investigations, CAPAs, and complaint reports. Ensure timely resolution of quality incidents and thorough documentation aligned with regulatory expectations. Support air flow visualization studies (smoke studies) and ensure quality oversight during execution.

Team Management & Development

Recruit, train, and mentor QA staff to ensure high performance and regulatory compliance. Conduct performance reviews and support career development of direct reports. Collaborate with cross-functional teams to identify and implement continuous improvement initiatives.

General

Reviews and approves GMP documents related to Quality Systems such as Manufacturing Investigation reports, complaints, etc. Recruits and trains staff to carry out all functions of the Quality Operations. Oversees the implementation of regulatory agencies regulations and Jubilant policies and procedures throughout the site to ensure that Quality Operations meet requirements. Ensures the maintenance and compliance of the Site Training procedures and the overall GMP training program for the site Periodically reviews the performance of direct reports with regards to the achievement of goals, objectives and key performance indicators. Brings to the attention of the Director, Quality Operations and Site Director, information relating to the impact of legislation on the functions of the site. From data trending, identify potential improvement opportunities and create implementation plans with different department managers. Act as quality representative to answer client's questions and concerns on behalf of JHS Montreal. Performs additional duties as assigned by Management Quality Assurance Leadership Lead a team of QA reviewers integrated into manufacturing operations for real-time decision-making and issue resolution. Provide immediate feedback and guidance to operators on aseptic techniques and contamination control.

External Interfaces:

Regulatory agencies Clients

Internal Interfaces:

Employees and Heads of all Departments

Education:

Education

Qualification(Highest)

BSc in life science with pertinent experience

Experience

Required:

5-10 years' experience in the pharmaceutical industry

Additional Preferred Experience:

Broad experience with regulatory and GMP standards associated with process control and validation, manufacturing and packaging, testing, with strong knowledge of Canadian, EU and US Food and Drug Regulations. At least 5 years of personnel management experience preferred

Skills Required:

Knowledge in aseptic processing and pharmaceutical processes Great knowledge in performing investigation and deep knowledge in root-cause analysis Excellent written and verbal communication skills. Computer literacy (Microsoft Office & SAP environment) Bilingualism (French & English). Skilled in problem solving and resolving issues. Open minded, curious and meticulous Demonstrated leadership skills Strong interpersonal and organizational skills.

Working Environment:

Physical

No special physical demands are required to perform the work.

Environmental

Work involves every day risks and does not require any special safety precautions.

Job Overview

DATE POSTED :

14/08/25

LOCATION :

Montreal, Quebec

COMPANY :

Jubilant HollisterStier General Partnership

FUNCTION :

Quality