Manager, Quality Control/ Responsable du Contrôle Qualité
Manager, Quality Control/ Responsable du Contrôle Qualité
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$ 80400 - 136700
1 Vacancy
Job Description
Job Description
Management of all facets of the in vitro Quality Control department in a compliant manner ensuring Quality Control is a good business partner to the manufacturing organization supporting release of quality product. The responsibilities of this role include European Good Manufacturing Practices requirements as specified in the Eudralex Volume 4 Part 1 Chapter 2.
Functions Duties Tasks:
To approve or reject test results as they see fit for starting materials packaging materials intermediate bulk and finished products.
To ensure that all necessary testing is carried out and the associated records evaluated.
To approve specifications sampling instructions test methods and other Quality Control procedures.
To approve and monitor any contract analysts.
To ensure the qualification and maintenance of his department premises and equipment.
To ensure that the appropriate validations are completed.
To ensure that the required initial and continuing training of department personnel is carried out and adapted according to need.
Authorization of written procedures and other documents including amendments.
Monitoring of the manufacturing environment including oversight of plant hygiene.
Oversight of method validation.
Ensure a robust training system is in place and utilized.
Approval and monitoring of suppliers of materials.
Approval and monitoring of contract laboratories and providers of other Good Manufacturing Practices related outsourced activities.
Designation and monitoring of storage conditions for materials and products.
Retention of records.
The inspection investigation and taking of samples in order to monitor factors which may affect product quality.
Participation in management reviews of process performance product quality and of the quality management system and advocating continual improvement.
Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
Maintain compliance with Canadian Food Inspection Agency United States Department of Agriculture (USDA) and Good Manufacturing Practices in every facet of Quality Control activity.
Ensure all testing is executed and reviewed in a compliant and timely manner meeting Quality Control service standards.
Management of all Quality Control personnel in the in vitro department including personnel development and performance management.
Oversight of the stability program ensuring Animal Health Quality Manual and Good Manufacturing Practices compliance are maintained and all products have data to support shelf life.
Responsible for assay development as required assay remediation and assay transfers.
Ownership of the technical responsibility for all externally tested assays for site products.
Responsible to ensure all Quality Control lab investigations are robust as well as responsible for supporting manufacturing investigations as relates to all facets of Quality Control testing (internal and external).
Continuance of the Operational Excellence program in the Quality Control lab.
Responsible for generating and maintaining the Quality Control budget.
Responsible for generation of regulatory document preparation/communication as related to Quality Control.
Oversight of Quality Control metrics.
Management of pharmacopeial gap assessments and implementation for the Prince Edward Island site.
Responsible to ensure Quality Control personnel have the appropriate training to execute their roles and that appropriate cross training occurs to maintain business continuity.
Ownership of Health Safety and Environment within the Quality Control environment.
Other duties as required.
Minimum Qualifications:
A Bachelors degree is in Biology chemistry biochemistry or microbiology or equivalent is required. A Masters degree is preferred.
Minimum 5 years laboratory experience Good Manufacturing Practices Training required.
Language required: English (written and spoken)
Preferred Qualifications:
Available to work evenings and weekends if required.
Strong leadership skills. Ability to effectively work with teams.
Strong interpersonal skills. Ability to work in multi-discipline teams at a fast pace.
Strong analytical skills. Ability to set priorities and manage multiple tasks.
Working technical knowledge in one or more of the following fields: sterile product manufacturing molecular biology analytical chemistry biology/microbiology biologics manufacturing.
Ability to effectively communicate verbally and in writing.
Strong focus on continuous improvement and operational excellence.
We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace.
The Company is required to provide a reasonable estimate of the salary range for this job in certain provinces within Canada. Final determinations with respect to salary will consider a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education. Expected CAD salary range: $80400 - $136700. Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays and vacation.
All candidates are required to have adequate and legal work authorization to work in Canada prior to applying for posted positions. Only candidates with valid work authorization not requiring company sponsorship in the course of their employment with our company will be considered in the recruitment process.
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
Gestion de tous les aspects du dpartement de Contrle Qualit in vitro de manire conforme en veillant ce que le Contrle Qualit soit un bon partenaire commercial pour lorganisation de fabrication soutenant la libration de produits de qualit. Les responsabilits de ce rle incluent les exigences des Bonnes Pratiques de Fabrication de lUnion Europenne telles que spcifies dans le Volume 4 Partie 1 Chapitre 2 de lEudralex.
Fonctions Devoirs Tches :
Approuver ou rejeter les rsultats des tests selon leur jugement pour les matires premires les matriaux demballage les intermdiaires les produits en vrac et les produits finis.
Sassurer que tous les tests ncessaires sont effectus et que les dossiers associs sont valus.
Approuver les spcifications les instructions dchantillonnage les mthodes de test et dautres procdures de Contrle Qualit.
Approuver et surveiller tout analyste sous contrat.
Sassurer de la qualification et de lentretien de son dpartement des locaux et de lquipement.
Sassurer que les validations appropries sont compltes.
Sassurer que la formation initiale et continue du personnel du dpartement est effectue et adapte selon les besoins.
Autorisation des procdures crites et dautres documents y compris les modifications.
Surveillance de lenvironnement de fabrication y compris la supervision de lhygine des installations.
Supervision de la validation des mthodes.
Sassurer quun systme de formation robuste est en place et utilis.
Approbation et surveillance des fournisseurs de matriaux.
Approbation et surveillance des laboratoires sous contrat et des prestataires dautres activits externalises lies aux Bonnes Pratiques de Fabrication.
Dsignation et surveillance des conditions de stockage des matriaux et des produits.
Conservation des dossiers.
Inspection enqute et prlvement dchantillons afin de surveiller les facteurs pouvant affecter la qualit du produit.
Participation aux revues de gestion de la performance des processus de la qualit des produits et du systme de gestion de la qualit et plaidoyer pour lamlioration continue.
Sassurer quun processus de communication et descalade efficace et en temps opportun existe pour remonter les problmes de qualit aux niveaux de gestion appropris.
Maintenir la conformit avec la Agence canadienne dinspection des aliments l United States Department of Agriculture (USDA) et les Bonnes Pratiques de Fabrication dans tous les aspects de lactivit de Contrle Qualit.
Sassurer que tous les tests sont excuts et examins de manire conforme et en temps opportun respectant les normes de service du Contrle Qualit.
Gestion de tout le personnel de Contrle Qualit dans le dpartement in vitro y compris le dveloppement du personnel et la gestion de la performance.
Supervision du programme de stabilit en veillant ce que la conformit au manuel de Qualit de sant animale et aux Bonnes Pratiques de Fabrication soit maintenue et que tous les produits aient des donnes pour soutenir leur dure de conservation.
Responsable du dveloppement des essais si ncessaire de la remdiation des essais et des transferts dessais.
Proprit de la responsabilit technique pour tous les essais tests lexterne pour les produits du site.
Responsable de sassurer que toutes les enqutes de laboratoire de Contrle Qualit sont robustes ainsi que de soutenir les enqutes de fabrication en ce qui concerne tous les aspects des tests de Contrle Qualit (internes et externes).
Poursuite du programme dExcellence Oprationnelle dans le laboratoire de Contrle Qualit.
Responsable de la gnration et du maintien du budget de Contrle Qualit.
Responsable de la prparation/communication des documents rglementaires en lien avec le Contrle Qualit.
Supervision des indicateurs de Contrle Qualit.
Gestion des valuations des carts en pharmacope et mise en uvre pour le site de lle-du-Prince-douard.
Responsable de sassurer que le personnel de Contrle Qualit a la formation approprie pour excuter ses rles et que la formation croise approprie a lieu pour maintenir la continuit des affaires.
Proprit de la Sant de la Scurit et de lEnvironnement au sein de lenvironnement de Contrle Qualit.
Autres tches selon les besoins.
Qualifications Minimales :
Un diplme de Bachelor en biologie chimie biochimie ou microbiologie ou quivalent est requis. Un diplme de Master est prfr.
Minimum de 5 ans dexprience en laboratoire formation aux Bonnes Pratiques de Fabrication requise.
Langue requise: anglais (oral et crit)
Qualifications Prfres :
Disponible pour travailler le soir et le week-end si ncessaire.
Solides comptences en leadership. Capacit travailler efficacement avec des quipes.
Solides comptences interpersonnelles. Capacit travailler dans des quipes multidisciplinaires un rythme rapide.
Solides comptences analytiques. Capacit tablir des priorits et grer plusieurs tches.
Connaissance technique oprationnelle dans un ou plusieurs des domaines suivants : fabrication de produits striles biologie molculaire chimie analytique biologie/microbiologie fabrication de biologiques.
Capacit communiquer efficacement loral et lcrit.
Fort accent sur lamlioration continue et lexcellence oprationnelle.
Nous sommes fiers dtre une entreprise qui embrasse la valeur de rassembler des personnes diversifies talentueuses et engages. La faon la plus rapide dinnover est de rassembler des gens de diverses opinions dans un environnement inclusif. Nous encourageons nos collgues remettre en question avec respect les problmes de rflexion et dapproche de lun et de lautre. Nous sommes un employeur souscrivant au principe de lgalit daccs lemploi et nous sommes dtermins favoriser un milieu de travail inclusif et diversifi.
Lentreprise doit fournir une estimation raisonnable de la fourchette de salaire pour ce poste dans certaines provinces du Canada. Les dterminations finales concernant le salaire prendront en compte un certain nombre de facteurs qui peuvent inclure mais sans sy limiter le lieu de travail principal et les comptences pertinentes lexprience et lducation du candidat choisi. chelle salariale attendue en CAD : $80400 - $136700. Les avantages disponibles comprennent lligibilit aux primes des incitations long terme le cas chant des avantages en matire de soins de sant et dautres assurances (pour lemploy et sa famille) des prestations de retraite des congs pays et des vacances.
Tous les candidats doivent avoir une autorisation de travail adquate et lgale pour travailler au Canada avant de postuler les postes affichs. Seuls les candidats disposant dune autorisation de travail valide ne ncessitant pas de parrainage de lentreprise pendant leur emploi dans notre organisation seront pris en compte dans le processus de recrutement.
Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Analytical Problem Solving Analytical Problem Solving Analytical Thinking Assay Assay Development Bioanalysis Biological Manufacturing Biopharmaceutical Industry cGMP Compliance Decision Making Detail-Oriented Driving Continuous Improvement GMP Compliance Immunochemistry Key Performance Indicators (KPI) Management Process Microbiology Molecular Biology Molecular Microbiology Organizational Performance Management People Leadership Quality Auditing Quality Control Management Quality Control Systems Quality Documentation 5 morePreferred Skills:
Job Posting End Date:
06/3/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Manager
Employment Type
Full-Time
