Manager, Quality Systems and Compliance - Eurofins CDMO Alphora, Inc

Eurofins

  • Mississauga, ON
  • Permanent
  • Full-time
  • 16 days ago
Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.In 2024, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.Eurofins CDMO Alphora Inc. develops and manufactures new therapeutics to improve the lives and health of patients. Eurofins CDMO Alphora provides contract research & development services to global pharmaceutical and biotech companies, developing their processes and manufacturing their bulk drug substances (Active Pharmaceutical Ingredients -“API's”) as well as finished dosage products (tablets, capsules, suspensions) for supply to clinical trials and commercial requirements. Eurofins CDMO Alphora provides a rich and technologically challenging environment with a continuing flow of interesting projects. Our employees work in close concert with clients throughout the development process to achieve their program objectives. Eurofins CDMO Alphora Inc. is growing its state-of-the-art organization, with continued investments in modern facilities, equipment, and instrumentation while providing a rich environment for employees to develop their technical skills and careers paths.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 compliance
  • Regulatory and client audit management, CAPA oversight
  • Validation and qualification programs for facilities, equipment, and processes
  • Quality metrics, data analytics, and training programs
  • Change control, document management, and vendor oversight
  • Regulatory support for commercial programs and site licensing
This 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 preferred
  • 5-10+ years of experience related to pharmaceutical quality, including previous supervisory experience.
  • Experience with pharmaceutical cGMP manufacturing, testing, validation / qualification, and regulatory are expected
  • Expertise in cGMP regulations and quality systems development is expected
  • Experience with Lean-Six Sigma and continuous improvement are assets
  • Proficiency in Microsoft Office (Word/Excel) is required
  • Strong written and verbal skills are a priority
  • A proficiency for multi-tasking
  • Excellent interpersonal skills, with a desire to teach and lead others
  • Good time management and project management skills
  • A focus on attention to detail
  • Be goal orientated and results driven
  • A 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 atWe 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

Eurofins