Manager, Laboratory Operations - TSAIL

We are seeking a Manager, Laboratory Operations - TSAIL to join IQVIA Laboratories in Durham, NC .

We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.

As a Manager, Laboratory Operations - TSAIL you will lead a team responsible for delivering high-quality and reproducible results from immunoassays performed on clinical patient specimens. You will ensure compliance with Quality Systems requirements and applicable guidelines and regulations, and oversee all aspects of laboratory testing, including scheduling, management of daily activities, and technical skills training.

What you'll be doing:

• Overseeing laboratory operations and managing a team of scientists responsible for production-scale testing with cell-mediated immune assays and other testing processes.

• Partnering with Assay Development to manage the operationalization and deployment of assays, including flow cytometry, ELISpot/Fluorospot, and other assays.

• Managing operations and overseeing the daily activities of assigned laboratory workers through appropriate delegation, technical skills training, coaching, and work supervision.

• Managing workload, scheduling, and materials to meet delivery timelines and drive progress to completion.

• Meeting regularly with senior management to determine priorities, discuss risks, and coordinate activities.

• Participating in defining study details, including input into study timelines with multiple stakeholders.

• Applying deep knowledge of lab testing procedures and the science behind them, along with applicable laboratory testing regulations, to ensure high-quality on-time delivery.

• Developing and assisting in the development of procedural documentation, including SOPs, maintaining documentation for safety and regulatory compliance, performing and overseeing final data analysis and report construction, and reviewing and signing off on all data and quality documents.

• Monitoring work, developing staff skills, and evaluating performance.

• Managing staff in accordance with IQVIA Laboratories policies and procedures, providing timely feedback on performance, and conducting performance evaluations.

• Ensuring that internal policies and procedures maintain alignment with evolving guidelines and regulations.

• Participating in the budget planning process based on revenue targets and financial goals, inclusive of consumables, instrumentation, and resourcing needs.

• Ensuring that costs are aligned with the budget and establishing a culture of cost control and continuous process improvement.

• Driving individual accountability for quality and safety across the team, leading quality and safety investigations, and driving resolution for enhancements.

• Ensuring timely and appropriate resolutions of quality incidents, quality and compliance metrics, root cause analysis, and process improvement.

• Fostering a unified culture and facilitating collaboration, cooperation, sharing of information, and teamwork.

• Participating in initiatives to improve employee engagement to positively impact operational results, customer satisfaction, and employee retention.

• Complying with corporate policies and procedures, as well as applicable regulatory requirements.

What we are looking for:

• PhD in Immunology or related discipline preferred, or Bachelor's/Master's degree with an equivalent combination of education and experience.

• At least 3-5 years of prior relevant experience, including management of a team and experience in a regulated laboratory.

• Other equivalent combinations of education, training, and experience may be accepted in lieu of a degree.

The knowledge, skills, and abilities needed for this role:

• Superior communication skills, accuracy, attention to detail, and capability of handling multiple tasks simultaneously.

• Proficiency in office productivity software and relevant statistical analysis.

• Ability to work with agility in a fast-paced environment.

• Outstanding knowledge of assay development best practices, flow cytometry, ELISpot/Fluorospot, and data analysis practices.

• Direct experience with Quality Assurance and Quality Control, coupled with an ability to develop an in-depth understanding of company-specific program requirements.

What we offer you:

We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees' physical, mental, emotional, financial, and social well-being so they can thrive at home and at work, at any stage of their well-being journey.

To learn more about our benefits, visit /jobs. iqvia. com/benefits (/protect-eu. mimecast. com/s/KVD3CYOAsLD28oWi0eTcK?domain=jobs. iqvia. com) .

If you're looking to unleash your potential, join IQVIA Laboratories to help make the extraordinary possible!

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at /jobs. iqvia. com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. /jobs. iqvia. com/eoe

IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. /jobs. iqvia. com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $92,700. 00 - $154,500. 00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA contributes to our shared goal of improving h.