Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. 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.

Responsible for directing and providing quality leadership for overall activities at Eurofins Advantar laboratories in compliance with 21 CFR Parts 210, 211, 11. Supports management team in providing quality data with accuracy, clarity, and adherence to cGMP regulations and/or support of GLP studies. Addresses client and auditors quality concerns as needed. Ensures that a proper system for documentation and data retrieval are available. Provides support and recommendations to Eurofins Advantar staff for quality and/or technical improvements.

Essential Duties, Activities, and Responsibilities:

• Applies cGMP in all areas of responsibilities
• Writes, reviews, approves, or directs the preparation and approval of all Standard Operating Procedures (SOP), and manufacturing batch records
• Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system
• Reviews and approves a variety of methodologies as applied to various stages of pharmaceutical development
• Assigns appropriate QA staff to review data packages and manufacturing batch records and documentation
• Coordinates QA projects workflow to meet site goals turnaround time
• Follows and facilitates site adherence to establish quality compliance measures and respective regulatory agencies, including FDA and EU GMPs
• Performs all functions in support of and in compliance with all state and federal employment regulations
• Manages and directs QA and Document control functions
• Hosts and supports regulatory and client audits
• Reviews and approves the Corrective Action and Preventive Action (CAPA) program.
• Coordinates and directs the vendor approval and internal audit programs
• Discusses compliance issues with responsible scientist, Project Director, or Area Management
• Assigns QA staff in training new employees
• Monitors and approves employees’ time worked through time-entry system
• Prepares and presents site metrics during Senior Management review
• Supports new quality initiatives and continuous improvements
• Supports LEAN Projects

Position has a pay range of $120,000- $140,000 

• Bachelors or Master’s degree in chemistry, biochemistry, biology, or one of the physical sciences
• ≥ 7 years of GMP pharmaceutical auditing experience
• ≥ 4 years of managing direct reports
• Experience with cGMP, GLP, ICH, EMA, and USP regulations

Position is Full Time,  Monday- Friday 8:00 AM- 5:00 PM. 

As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work.  We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and PTO, and dental and vision options.

To learn more about Eurofins, please explore our website www.eurofinsus.com.

We are looking forward to receiving your application including your expected salary and possible start date via our career website.

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