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Manager, Quality Systems and Compliance
2 weeks ago
Job DescriptionJoin a Leader in Pharmaceutical Excellence – Eurofins CDMO Alphora is looking for a Manager, Quality Systems and ComplianceAre you passionate about driving quality and compliance in a dynamic, science-driven environment? Eurofins CDMO Alphora Inc. is seeking a Manager, Quality Systems and Compliance to lead our Compliance team in upholding and advancing our Quality Management System (QMS). This pivotal role ensures our operations meet and exceed cGMP standards, supporting the development and manufacture of safe, effective pharmaceuticals for both clinical trials and commercial markets.As a key leader, you will oversee the implementation of robust quality systems across all cGMP business units—including Drug Substance, Drug Product, and Biologics. From managing audits and regulatory submissions to spearheading validation programs and continuous improvement initiatives, you’ll play a critical role in shaping the quality culture of our organization.What You’ll Lead:Development and maintenance of QMS for cGMP complianceRegulatory and client audit management, CAPA oversightValidation and qualification programs for facilities, equipment, and processesQuality metrics, data analytics, and training programsChange control, document management, and vendor oversightRegulatory support for commercial programs and site licensingThis is more than a compliance role—it’s a leadership opportunity to influence quality excellence and patient safety on a global scale.QualificationsThe ideal candidate will have:Minimum BSc; specialization in chemistry, biochemistry, biology, pharmacy is preferred5-10+ years of experience related to pharmaceutical quality, including previous supervisory experience.Experience with pharmaceutical cGMP manufacturing, testing, validation / qualification, and regulatory are expectedExpertise in cGMP regulations and quality systems development is expectedExperience with Lean-Six Sigma and continuous improvement are assetsProficiency in Microsoft Office (Word/Excel) is requiredStrong written and verbal skills are a priorityA proficiency for multi-taskingExcellent interpersonal skills, with a desire to teach and lead othersGood time management and project management skillsA focus on attention to detailBe goal orientated and results drivenA desire to learn and for continuous personal development Additional InformationAt Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at .As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at We thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.This posting is supported by AI technology to assist in screening candidates and resumes.NO AGENCIES, CALLS OR EMAILS PLEASE
