Job Description
Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Stage Clinical and Phase I IV Clinical Research services. We welcome individuals who want to be part of our growing organization. QPS is an innovative, dynamic organization that strives to employ talented, caring and committed employees who will work collaboratively towards achieving our mission of improving human health and the quality of life. QPS offers challenging and rewarding work in its four core business areas and support functions. Underpinning the operation is a culture that values diversity, innovation and accountability. Employees are encouraged to take responsibility and achieve their best, both as individuals and as team members.
Description:
The Director of Laboratory Services is responsible for the overall management of the clinical laboratory and/or multiple departments including administrative, financial, compliance, quality improvement, technical, and personnel activities in accordance with established laboratory policies and standards. The Director of Laboratory Services directly reports to the Head of Administration on location as well as works closely with all site leadership team members to initiate and/or maintain cohesive operations for the site. The Director of Laboratory Services is responsible for the proper creation of policies, manuals, collection kits, technologies and processes for the operations of Central Safety Laboratory services. The clinical lab offers central lab services to which the director will facilitate the proper training for QPS global business development on the offerings of the lab, look for gaps from competition and create training and work with marketing to create visuals for clients. This position is required to follow all QPS site and global policies as well as working together with other team members to provide continuity of services for all operations.
This position offers a full-time schedule that will be primarily days Mon-Fri. It may include potential periodic evenings or weekends.
Responsibilities:
· Enforce all laboratory policies and procedures.
· Responsible for site and central laboratory financial planning, ordering of supplies, and labor oversight.
· Participates in and oversees the policy and procedure writing process. Responsible for approving all laboratory policies and procedures.
· Meet with Sponsors to identify client needs.
· Working very closely with project management, business development and clients to fulfill any needs required by Sponsors and CRO’s in a timely manner.
· Responsible for analyzer selection, test menu implementation, and coordinating implementation, validation, and correlation testing operations.
· Resolve problems encountered by the laboratory to improve delivery of laboratory services.
· Develops and enforces ongoing quality management system activities for pre-analytic, analytic, and post-analytic metrics.
· Evaluates QC to ensure laboratory testing is completed according to policy.
· Takes on special projects or other assignments and completes them within a time frame.
QUALIFICATIONS:
· Bachelor of Science degree in a scientific field to meet requirements of Clinical Laboratory Improvement Act (CLIA) & CAP required.
· Possession of a valid license or certificate of Clinical Laboratory Scientist or Medical Technologist or Medical Laboratory Scientist, ASCP required.
· Minimum 5 years supervisory clinical laboratory experience required.
· Quality Control and quality tools management courses preferred.
· General Accounting and statistics and financial operating experience preferred.
· Experience in a central laboratory environment with CRO and clinical research preferred.
· LEAN Six Sigma certification preferred
· Master’s Degree preferred.
Outstanding Benefits:
· Retirement Savings Plan
· Paid Vacation
· Paid Holidays
· Paid Sick Time
· Personal Days
· Employee Assistance Program
· Life Insurance
· Health, Dental, Vision
· Long Term Disability Insurance
· Other Benefits
EEO Minorities/Females/Protected Veterans/Disabled
QPS is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. QPS prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. QPS conforms to the spirit as well as to the letter of all applicable laws and regulations.
Full-time