Eurofins 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 just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 58,000 staff across a network of more than 1000 independent companies in over 54 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

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Eurofins CDMO Alphora Inc. provides a fully integrated suite of services to support drug substance and drug product development from the IND enabling development stage, through to phase II & III supply, and commercial validation and manufacturing for niche APIs.  In addition to a continuing flow of interesting and challenging projects for global pharmaceutical and biotech companies, Eurofins CDMO Alphora Inc. is committed to growing its state-of-the-art organization, with continued investments in its people, modern facilities, equipment, and instrumentation.

POSITION SUMMARY:

The Manager, Quality Assurance will effectively lead and manage Eurofins CDMO Alphora Inc.’s Quality Assurance programs and department to ensure production and operations are carried out in compliance with current Good Manufacturing Practices (cGMP).  The role is primarily responsible for ensuring that quality systems are effectively executed to ensure that API products and development services provided are of the highest quality, surpassing the expectations of our customers and the regulatory authorities.  Strong collaboration and teamwork with Operations, Quality Control, Technical Services, Analytical Services, and Research & Development will be required to meet both quality and business objectives.

KEY DUTIES AND RESPONSIBILITIES:

• Responsible for leadership and overall management of the Quality Assurance team, effectively supporting QA programs for Operations, Research & Development, Analytical Services, and Quality Control departments across multiple shifts.
• Ensure that cGMP and Quality Management System requirements are comprehensively fulfilled, in collaboratively supporting company development, clinical and commercial API fabrication.
• Responsible to ensure that Standard Operating Procedures (SOP’s) are developed, maintained and followed; and these are reflective of current industry regulations and guidance’s, and customer expectations.
• Coach, develop, and mentor the QA department staff to ensure that support to achieving business objectives continuously improves.
• Responsible for effective budgetary management of the department.
• Responsible for oversight and management of Batch Record reviews and releases, including issuance and approval of CofA’s and other required documentation.
• Lead the timely, comprehensive, and effective investigation of Deviations and OOS’s to ensure that these result in identification of scientifically sound root cause and robust CAPA’s.
• Develop, implement, and maintain Quality Metrics to drive continuous improvement results.
• Responsible for QA data analytics supporting investigations and other areas.
• Responsible for oversight and management of review and release for all analytical data file packages (TDF’s); for API’s, intermediates, IPC’s, raw materials, cleaning validation/verification samples.
• Responsible for oversight of review and approval of analytical method development/validations reports; and analytical/reference standard qualification.
• Responsible for oversight of review and approval of stability protocols, data and reports.
• Responsible for approval and management of batch Master Documentation.
• Management, oversight, and QA approval of PM/Calibration program, facility temperature/humidity monitoring, logbook issuance/control, quality system numbering/control, environmental monitoring, and item/compound codes issuance. 
• Champion system and data integrity compliance.
• Responsible for approval of Facility/Utility/System/Equipment/Process Qualification.
• Provide support to host regulatory and client cGMP audits for the organization.
• Responsible for strict personal and departmental adherence to company Health and Safety policies and procedures.
• Other duties as assigned.

The ideal candidate will have:

• Minimum BSc; specialization in chemistry is preferred
• 5-10+ years of experience related to pharmaceutical quality, including previous supervisory experience. (Knowledge/experience with pharmaceutical manufacturing, testing, and regulatory are assets)
• Expertise in cGMP regulations and quality systems 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

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 www.eurofins.ca

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 www.eurofins.ca

We thank all applicants for showing an interest in this position. Only those selected for an interview will be contacted.

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