QA Manager

Company Description

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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It 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 Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Job Description

Under directive from senior leadership, the Quality Manager will ensure quality systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards. He/she will promote a culture of quality for the Company. Candidates in this position will report on the performance of the Quality System to senior leadership. Additionally, candidates will manage and direct quality personnel, assigning and assuring their daily duties are carried out in accordance with internal procedures.  This position will be centrally located in the United States and will oversee quality personnel and systems at multiple locations.

Responsibilities

• Oversee in all aspects of Quality Assurance to ensure calibration activities are performed in compliance with both internal procedures and ISO/IEC 17025:2017 requirements.
• Oversee the internal auditing program nationally to ensure the established techniques are followed and understood.

• Oversee in the planning, preparation, and hosting of customer audits and accreditation assessments; respond to audit reports and implement resolution of audit findings; complete Supplier assessment evaluations.

• Maintain and control global procedures including Standard Operating Procedures, Protocols, Forms, CAPAs, Deviations, Nonconformances, Complaints/Inquiries, Change Orders, calibration records, training records and logs.
• Manage and control the Document System nationally
• Create, revise, review, and approve newly written documents and document revisions.
• Work with senior leadership to maintain the training program and ensure that operations personnel have completed all necessary training requirements.
• Conduct personnel training, where deemed appropriate
• Overall responsibility for the Management Review process across the organization.
• Assist senior management in ensuring all licenses remain current (e.g. ISO, City, etc.)
• Collect, track, and analyze quality metrics (OOS, NCMRs, CAPAs, complaints, etc.) and train calibration personnel, as needed to help reduce quality events.
• Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP-related items, as needed to help minimize laboratory errors and audit findings.
• Maintain client confidentiality, specifically if information about the customer is obtained from sources other than the customer (e.g. complainant, assessors, etc.).
• Acts impartially within the management system and communicates identified impartiality risks/concerns to management for assessment.
• Communicate any problems that might affect job performance to direct supervisor.
• Utilize lean and risk management methodologies to design, implement, and continuously refine standardized processes, driving departmental efficiency and consistent quality. 
• Exist as a backup for all other Quality Assurance personnel.
• Other duties as assigned by departmental management.

Qualifications

Requirements

• Bachelor’s degree in chemistry, biological science, or other related science field
• 3+ years of experience working in a Quality Assurance role at an ISO 17025:2017 accredited facility, with a preference of at least 2+ of those years being in a leadership role
• Must be a detail-oriented, problem solving, self-initiating individual with strong interpersonal written and oral communication skills
• Strong organizational skills, and ability to multitask in a dynamic, fast-paced
  environment.
• Displays sound judgment and ambition; is quality focused; displays good communication skills; good implementation and follow-up skills.
• Hands-on experience with CAPA, change control, and validation documentation (IQ/OQ/PQ) is preferred.

Additional Information

Working schedule will be Full-Time, First Shift, M-F 9am-5pm. Candidates currently living within a commutable distance of St. Louis, MO are encouraged to apply. 25% travel may be required. No relocation assistance will be given. This position is NOT remote. 

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 USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.