Quality Assurance Team Lead - Eurofins BioPharma Product Testing

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 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 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 specialized clinical diagnostics testing.  

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

BASIC FUNCTION: This role works both within and outside the company for the benefit of Eurofins and its clients. The successful incumbent will have 8+ years of experience in Quality Assurance, Compliance and/or other related area in a matrixed Life Sciences (Consumer, Pharmaceutical and/or Medical Device) organization as well as integrity, strong attention to detail, and the capability to work successfully within a small team of Regulatory and QA professionals.

POSITION SUMMARY: The QA Team Lead will be responsible for managing the quality system programs in the facility, coordinating the QC/QA team, creating and maintaining procedures that conform to Good Manufacturing Practices (GMPs) training employee on quality, participating in audits from clients and agencies, and developing quality systems. 

The ideal candidate in the position will be experienced in handling a wide range of QA- and Regulatory Affairs -related tasks and will be able to work independently with minimal supervision.  The incumbent must be energetic, exceedingly well-organized, flexible, and enjoy the administrative challenges of supporting a consulting team.  The incumbent must have the ability to interact with staff in a fast-paced environment, consistently under pressure, while remaining proactive, resourceful, and efficient.  A high level of professionalism and confidentiality is crucial to this role.  Previous QA and Regulatory experience is required.

PRINCIPAL DUTIES:

• Coordinate all activities required to meet quality management system (QMS) standards
• Manage Customer quality requirements e.g. Specifications, Quality Agreements, product portfolios
• Collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS
• Maintain establishment of licenses and any other regulatory compliance requirements
• Ensure procedures are properly understood, carried out and evaluated
• Ensure process and product changes are investigated and documented (e.g., deviations, out-of-specification, change control)
• Ensure that the level of non-conformance investigations are sufficient to ensure appropriate CAPA and prevention of recurrence
• Ensure regulatory requirements are met prior to the release of finished goods
• Develop SOPs as required and, where appropriate, advise on changes and their implementation
• Provide direction, coverage and assistance to the QA/QC staff as required.
• Identify relevant quality-related training needs and deliver training
• Manage customer complaint process
• Ensure complaints are examined and investigated thoroughly to determine root causes.
• Communicate with the Regulatory body for any reportable situations including, product recalls, medical device advisory notices and ADR’s, (adverse reactions to marketed health products)
• Conduct annual product reviews (APQR) consistent with applicable regulatory requirements
• Assist with and participate in internal and external audits and manage GMP self-inspection activities
• Liaise with all internal managers and staff throughout the organization to ensure that the QA system is functioning properly
• Provide consultation to customers and company management on day-to-day issues that have the potential to result in non-compliance and/or product non-conformance
• Other duties as assigned

Qualifications

• 5+ years relevant work/management experience required
• 8+ years’ experience in Quality Assurance, Compliance and/or other related area in a matrixed Life Sciences (Consumer, Pharmaceutical and/or Medical Device) organization required
• University degree in Chemistry, Chemical Engineering, Life Sciences, or related discipline.

·        Post-secondary diploma/certificate in Regulatory Affairs and Quality Control, or related field

·        Experience with quality system and compliance reporting required

• Working knowledge of Health Canada or equivalent health authority GMP regulations required
• Understanding of regulatory bodies approach to inspections and how to respond to regulatory body observations is preferred
• Experience in the pharmaceuticals and dietary supplements industry is preferred
• Exceptional organization skills required
• Meticulous attention to detail with the ability to anticipate obstacles and barriers and mitigate these issues required

·        Willingness to learn with the ability to retain information quickly and apply knowledge to various scenarios

·        Excellent written and verbal communication skills required

• Bilingualism French & English is a strong asset
• Ability to work independently and manage multiple priorities and deadlines in a fast-paced environment required

·        Must be proactive, self-disciplined, and able to demonstrate a high level of productivity

·        Proficiency with Microsoft Office – Word, Outlook, Excel required

• Travel: ~10% travel may be required

WORKING CONDITIONS: 

·        This position allows for a hybrid work-from-home/office arrangement, after necessary training period completed

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. NO AGENCIES, PHONECALLS OR EMAILS PLEASE