Microbiology CLIA Director

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 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 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.

Job Description

GENERAL JOB DESCRIPTION

The CLIA Microbiology Director shall:

Support Eurofins Donor & Product Testing business philosophy, leadership
values and ethics.
All employees are expected to meet basic expectations of DPTs quality
management system, including, but not limited to good workmanship,
adherence to standard operational procedures, training, good documentation
practices, accurate recordkeeping so the company may meet its stated quality
policy and objectives.
Responsible for the development and execution of the laboratory structure
and organization at each site.
CLIA regulations require a high complexity laboratory to have a Laboratory
Director available to oversee the overall operation and administration of the
laboratory
Responsible for the development and execution of the laboratory structure
and organization
Maintain continuous lab operations with integrity and validity for all
laboratory activities
Responsible for oversight of the Microbiology laboratory leadership team to
ensure timely delivery of quality test results, will interact with
customers, provide strong technical leadership, and collaborate
effectively across groups within the organization
ROUTINE BUISNESS OPERATIONS

Oversees and directs Eurofins DPT Microbiology and Sterility Management
Focus on strengthening individuals and their capabilities to build a
leadership pipeline
Maintain quality accuracy and ensure all quality monitors meet laboratory
objectives
Enforce applicable policies and procedures throughout the entire laboratory
operation
Develops, implements & enforces laboratory policies, procedures &
performance standards affecting wide range of customer entities (Organ
Procurement Organizations, Tissue Banks, etc.)
Work directly with the Director of Laboratory Operations to plan,
develop, and drive the vision and strategy of this laboratory to meet the
companys set objectives
Participates in developing new methodologies & tests and develops
strategic planning initiatives
Oversees all laboratory testing and provides scientific expertise to staff
for all human related specimens
Reports critical information to Executive Team, as needed
Demonstrates passion and enthusiasm for the companys vision, and
motivates, leads, and empowers others to achieve company goals
Evaluate automation of current and new testing platforms based on the needs
and capacity of the department
Pla and have oversight of the implementation of new instrumentation to
increase efficiency of laboratory processes
Recommends new technology/equipment for the laboratory and works within
DPTs budget cycle
Establishes quantitative financial metrics by which the laboratories
efficiency and effectiveness can be evaluated; identifies opportunities for
improvement (Consumables/personnel as a % of revenue)
Ensures timely review and approval of all laboratory procedure and safety
manuals, review and approval of all proficiency testing results (before
submission to vendor and upon receipt of evaluation report) demonstrated by
comments, signature/date
Ensures an annual review of training and competency files and corrective
action plans/reports demonstrated by comments, signature/date
Continuous staffing model assessment and oversight of headcount for the
Microbiology department
Evaluates department personal headcount structure and can prepares
justifications for additions
Ensure that prompt corrective action is taken for all lab audit findings or
deficiencies noted
Serve as a laboratory departmental liaison during regulatory inspections
and/or client audits
Consistent communication with Executive Leadership to ensure they are aware
of relevant matters