Technical Scheme Manager - GMP

Company Description

Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical 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, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 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.

Job Description

The core responsibility of the Eurofins Food Assurance Certification US Technical Scheme Manager is to design and manage compliance with ISO 17065 of all scheme elements for the assigned program area/s and to provide subject matter expertise (SME) for good manufacturing practices (GMP) regulations and standards for drugs, dietary supplements and cosmetics supporting program design, operations and development. Core responsibilities include management of scheme owner relationships, owning program documents and policies, technical oversight and input on marketing and sales promotional material, performing audits and leading auditor training and providing regular calibrations, serving as SME for stakeholder technical questions, representing Eurofins Assurance to clients and trade groups as a scientific thought leader, and performing technical reviews of audit reports or client CAPAs.

Key Responsibilities

Reporting into the Business Unit Manager, the Healthcare Assurance US Technical Scheme Manager is responsible for design, development, execution and compliance to scheme technical and ISO 17065 accreditation requirements across the assigned certification activities in the United States. This program area delivers services comprised primarily of dietary supplements, OTC drugs and cosmetics industry good manufacturing practices certification and supplier auditing, with the potential to own other related and aligned assurance services. This generally includes the following:

• Serve as SME for assigned program area/s, which may also include engagement with and relationship management of external scheme owners.
• Develop and maintain scheme documents, policies and procedures relevant to assigned program area/s.
• Maintain knowledge of and assure program compliance with ISO 17065 independent third party assessment principles.
• Perform third-party style audits against scheme requirements whether proprietary or against regulations or public standards.
• Govern competency requirements and perform scheme specific training for a global audit and technical reviewer teams and other internal operational and sales personnel.
• Offer robust and prompt support to clients and internal colleagues, addressing technical queries with clarity and precision.
• Perform technical review of facility or product audits and assessments, as part of the certification process, ensuring all scheme specific KPIs are met.
• Support and facilitate internal and accreditor audits of scheme records and procedures.
• Collaborate with the marketing and sales teams to produce engaging and informative materials for trade events, webinars or business development.
• Maintain up to date technical expertise in the relevant technical area/s though continuing education.
• Actively participate in and present at industry events toward promoting the value proposition of Eurofins certification services.
• May engage in standards development activities for organizations like ANAB and ISO, contributing to the evolution and understanding of industry benchmarks.
• Contribute to as an advisory and hands-on role in guiding program development strategy.
  
  
  

Essential Duties

• Apply expert knowledge of manufacturing regulations, standards and certification practices to interpret certification program technical requirements and compliance thereof.
• Apply expert knowledge of manufacturing regulations, standards and certification practices to design custom, new certification programs including all associated auditing and review policies and procedures.
• Applies expert knowledge of manufacturing regulations, standards and certification practices to train the global certification staff to program requirements.
• Travel within the United States and internationally to perform manufacturing facility audits.
• Apply good practices in all areas of responsibility, as appropriate.
• Prioritize a commitment to excellent and responsive internal and external customer service.
• Demonstrates and promotes the company vision.
• Ensures that Eurofins has appropriate procedures, work ethics and policies in place to guarantee a high quality of service to clients and accreditation compliance.
• Maintains confidentiality and impartiality in all aspects of work and adhere to all procedures established by Eurofins and key clients.
• Manages employee relation issues as per company guidelines and with the support of Human Resources
• Verifies that company employment policies and procedures are being followed correctly.
• Conducts all activities in a safe and efficient manner.
• Performs other duties as assigned.
  
  
  

Qualifications

• Bachelor's or advanced degree in Food or Nutrition, Quality, Pharmaceuticals or another relevant scientific field.
• Minimum 3 years of experience in a manufacturing, quality or regulatory role, ideally in either the dietary supplement or pharmaceutical industries.
• Experience working in the third-party certification industry.
• Demonstrated ability to function in a collaborative environment with knowledge and capabilities to secure appropriate support resources to achieve business goals.
• High proficiency and fluent in written and spoken English.
• Out of the box critical thinker, self-motivated, result-driven and capable of working both independently and with a project team.
• Travel is required is required mostly in the US, to a lesser degree in Europe, sometimes Asia.
• Authorization to work in the United States indefinitely without restriction or sponsorship
  
  
  

Knowledge Requirements

• Technical – Knowledge of regulatory requirements and practices, good manufacturing practices and quality management systems across a range of industries including drug, cosmetic and dietary supplements. Ability to communicate procedural requirements though written standard operation procedures.
• Administration and Management — Knowledge of project management principles strategic planning, continuous improvement, resource allocation, and coordination and influence of people and resources.
• Customer and Personal Service — Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
  
  
  

Additional Information

Position is Full-Time, Monday-Friday, 8:00 a.m.-5:00 p.m., with additional hours, as needed.

What We Offer

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
  
  
  

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins USA Consumer Product Testing is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.