Job Description

As part of the Quality team, the Senior Associate, Quality Assurance is responsible for oversight of quality projects and programs to ensure compliance of the production, testing, and distribution of Aqua Vaccines, while seeking opportunities for improvement of established quality processes.

Main Responsibilities & Duties

• Management of Quality Assurance projects with a focus on compliance, productivity, and improvement of quality metrics. Leads these teams through project planning, organization and tracking of project deliverables.
• Preparation of risk assessments, protocols, Standard Operating Procedures, training materials and gap assessments.
• Work closely with Quality Assurance stakeholders on multidisciplinary projects that require quality consultation; this may include management of multi-stakeholder projects that directly influence compliance and manufacturing outcomes.
• Complete Technical and Quality Agreements.
• Work closely with Quality Assurance stakeholders to provide input into protocol development and to ensure protocols are compliant with our company's and GMP standards.
• Review and approval of executed validation / qualification protocols and reports.
• Manage Quality Assurance regulatory and internal inspection preparation. Participates in a lead support role during inspections.
• Conducts site self-inspections and Quality Assurance walkthroughs.
• Release of equipment and facilities.
• Supporting the implementation of our company's Animal Health Quality Manual as required.
• Shared responsibility for the following quality systems: change controls, quality events and investigations, Corrective and Preventative Actions, and out of specification.
• Provides initial assessment of quality events, investigations, Corrective and Preventative Actions, and OOS for completeness and compliance.
• Leads cross functional teams (when required) in investigations and analysis to determine root cause and aids in the resolution of issues.
• Provides initial assessment of quality events, investigations, Corrective and Preventative Actions, and OOS for completeness and compliance.
• Leads cross functional teams (when required) in investigations and analysis to determine root cause and aids in the resolution of issues.
• Involves site subject matter experts for final assessment and closure.
• Approves deviations
• Preparation and approval of change controls and impact assessments
• Tracking and trending of all systems to ensure timely closure and follow up where required.
• Other duties as required.

Qualifications and Experience

Minimum Qualification (education, experience and/or training, required certifications):

• Minimum of a Bachelor of Science degree or equivalent.
• At least 5 years in Quality Assurance and or current Good Manufacturing Practices facility operation experience.
• Crossfunctional collaboration experience with multiple teams (indirect or direct leadership experience is an asset)
• Proven ability to work independently due to the highly independent nature of this role.
• Focused on achieving goals and persistent when faced with obstacles.
• Adaptable to quick changes in required activities or duties.
• Thinks critically to support the needs of Quality Assurance but also considers business impact.
• Excellent communication skills, in both verbal and written form.
• Language requirement: English

Additional Preferences:

• Proficiency with business applications such as Adobe, MS Office, Word, Excel, Access, Project, Visio, and PowerPoint.
• General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry required.
• Good problem-solving skills.
• Experience in root cause analysis.
• Work effectively in cross-functional teams.

Health and Safety

• Display Screen Equipment. > 2/3 time
• Display Screen Equipment. > 2/3 time
• Sit - > 2/3 time
• Lift (<5Kg) - < 1/3 time
• Close vision, distance Vision and color Vision: Yes

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 another’s 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 candidate’s relevant skills, experience, and education. Expected CAD salary range: $61,900- $105,300. 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.

Required Skills:

Accountability, Accountability, Aseptic Manufacturing, Audits Compliance, Biotechnology, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Documentations, Driving Continuous Improvement, GMP Compliance, IS Audit, Microsoft Office, Project Management, Quality Assurance (QA), Quality Assurance Processes, Quality Assurance Systems, Quality Assurance Tools, Quality Auditing, Quality Management System Implementation, Quality Management System Improvement, Quality Management Systems (QMS), Quality Standards, Regulatory Project Management, Regulatory Requirements {+ 4 more}

Preferred Skills:

Secondary Language(s) Job Description:

En tant que membre de l’équipe Qualité, l’Associé principal, Assurance qualité est responsable de la supervision des projets et programmes qualité afin de garantir la conformité de la production, des tests et de la distribution des vaccins aquacoles, tout en identifiant des opportunités d’amélioration des processus qualité existants.

Responsabilités et tâches principales :

• Gestion des projets d’assurance qualité axés sur la conformité, la productivité et l’amélioration des indicateurs qualité. Dirige les équipes via la planification, l’organisation et le suivi des livrables.
• Préparation des évaluations de risques, protocoles, procédures opérationnelles normalisées, supports de formation et analyses des écarts.
• Collaboration avec les parties prenantes en assurance qualité sur des projets multidisciplinaires nécessitant une expertise qualité, incluant la gestion de projets multi-acteurs influençant directement la conformité et les résultats de fabrication.
• Rédaction et finalisation des accords techniques et qualité.
• Contribution au développement des protocoles et vérification de leur conformité aux normes internes et GMP.
• Revue et approbation des protocoles et rapports de validation/qualification exécutés.
• Préparation aux inspections réglementaires et internes, avec rôle de soutien principal lors des inspections.
• Réalisation d’auto-inspections et de visites qualité sur site.
• Libération des équipements et installations.
• Soutien à la mise en œuvre du Manuel Qualité Santé Animale de l’entreprise.
• Responsabilité partagée des systèmes qualité : changements, événements qualité, CAPA (actions correctives et préventives) et hors spécifications.
• Évaluation initiale des événements qualité, enquêtes, CAPA et OOS pour conformité.
• Direction d’équipes transversales pour enquêtes et analyses des causes racines.
• Approbation des déviations, préparation et validation des changements et évaluations d’impact.
• Suivi et analyse des tendances pour garantir la clôture rapide des actions.
• Autres tâches selon les besoins.

Qualifications minimales :

• Diplôme universitaire en sciences ou équivalent.
• Minimum 5 ans d’expérience en assurance qualité et/ou en exploitation d’installations GMP.
• Expérience de collaboration interfonctionnelle avec plusieurs équipes (une expérience de leadership direct ou indirect est considérée comme un atout).
• Capacité avérée à travailler de manière autonome.
• Orientation résultats et persévérance face aux obstacles.
• Adaptabilité aux changements rapides.
• Esprit critique conciliant besoins qualité et impact business.
• Excellentes compétences en communication orale et écrite.
• Exigence linguistique : anglais.

Atouts supplémentaires :

• Maîtrise des outils bureautiques (Adobe, MS Office, Word, Excel, Access, Project, Visio, PowerPoint).
• Connaissance générale des exigences réglementaires pour l’industrie pharmaceutique, biotechnologique ou vaccinale.
• Compétences en résolution de problèmes et analyse des causes racines.
• Capacité à travailler efficacement en équipes transversales.

Santé et sécurité:

• Écran de visualisation: > 2/3 du temps
• Position assise: > 2/3 du temps
• Levage (<5 kg): < 1/3 du temps
• Vision rapprochée, éloignée et perception des couleurs: Oui

Nous sommes fiers d'être une entreprise qui embrasse la valeur de rassembler des personnes diversifiées, talentueuses et engagées. La façon la plus rapide d’innover est de rassembler des gens de diverses opinions dans un environnement inclusif. Nous encourageons nos collègues à remettre en question avec respect les problèmes de réflexion et d’approche de l’un et de l’autre. Nous sommes un employeur souscrivant au principe de l’égalité d’accès à l’emploi et nous sommes déterminés à favoriser un milieu de travail inclusif et diversifié.

L’entreprise doit fournir une estimation raisonnable de la fourchette de salaire pour ce poste dans certaines provinces du Canada. Les déterminations finales concernant le salaire prendront en compte un certain nombre de facteurs, qui peuvent inclure, mais sans s'y limiter, le lieu de travail principal et les compétences pertinentes, l'expérience et l'éducation du candidat choisi. Échelle salariale attendue en CAD : $61,900- $105,300. Les avantages disponibles comprennent l'éligibilité aux primes, des incitations à long terme le cas échéant, des avantages en matière de soins de santé et d'autres assurances (pour l'employé et sa famille), des prestations de retraite, des congés payés et des vacances.

Tous les candidats doivent avoir une autorisation de travail adéquate et légale pour travailler au Canada, avant de postuler les postes affichés. Seuls les candidats disposant d'une autorisation de travail valide, ne nécessitant pas de parrainage de l'entreprise 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

01/5/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

**Requisition ID:**R376186