Technical Scheme Manager

4 weeks ago

Des Moines IA, United States Eurofins Full time

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.
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.
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. 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.
Govern competency requirements and perform scheme specific training for a global audit and technical reviewer teams and other internal operational and sales personnel.
Perform technical review of facility or product audits and assessments, as part of the certification process, ensuring all scheme specific KPIs are met.
Collaborate with the marketing and sales teams to produce engaging and informative materials for trade events, webinars or business development.
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.
Ensures that Eurofins has appropriate procedures, work ethics and policies in place to guarantee a high quality of service to clients and accreditation compliance.
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.
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.
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.
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.
This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
Position is Full-Time, Monday-Friday, 8:00 a.m.-Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
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.

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