Senior Quality Associate/ Associé principal

Job DescriptionAs 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 & DutiesManagement 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 deviationsPreparation and approval of change controls and impact assessmentsTracking and trending of all systems to ensure timely closure and follow up where required.Other duties as required.Qualifications and ExperienceMinimum 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: EnglishAdditional 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 SafetyDisplay Screen Equipment. > 2/3 timeDisplay Screen Equipment. > 2/3 timeSit - > 2/3 timeLift (