Global Lead, Quality Lab Information Management Systems - Lakewood, United States - Terumo BCT

Description

Requisition ID: 32183

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.

As the Global Lead, you'll be at the helm of an exciting initiative to develop a Lab Information Management System (LIMS) customized for manufacturing labs across the globe. Leading this transformative endeavor, you'll leverage your expertise in both laboratory operations and scalable software design to create a solution that revolutionizes the organization. Working closely with diverse teams spanning various regions, including skilled IT professionals, you'll drive the adoption of digital, transformative practices in laboratories while ensuring global regulatory compliance. Join us in reshaping our future of manufacturing labs and make a lasting impact on the organization.

ESSENTIAL DUTIES/RESPONSIBILITIES

• Serves as global SME for LIMS and trains global lab personnel to adopt the system.
• Leads LIMS site adoption globally.
• Collaborate with team members, site users as well as IT team to gather user requirements as well as update/enhance and/or develop the system within defined regulatory and company requirements.
• Interprets and analyzes data; performs basic data analysis.
• Review user requirement specification, functional documents provided by IT.
• Develop LIMS global procedure/user manual.
• Monitor site with implementation of LIMS and ensures the system is used globally to its intended capabilities. Presents basic data to internal department.
• Troubleshoots issues with LIMS and interacts with users and IT team to successfully resolve issues.
• Review and prioritize all LIMS system changes and enhancement requests with help from management and IT.
• Ensure software systems meet the requirements of 21 CFR part 11 and company's requirements.
• Optimizes workflows and improves processes.
• On annual basis reviews licenses available for the system versus requested and communicates needs to management.
• Develop LIMS expertise at global manufacturing labs.
• Provide support during regulatory and internal audits.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor's degree in a scientific discipline.

Experience

• Minimum 5-7 years or a master's degree with at least 3-5 years relevant experience developing or maintaining a Lab Information Management System (LIMS).
• Good understanding of 21 CFR Part 11 is required.
• Experience with regulated medical device or pharmaceutical industry strongly preferred.
• Prior experience with LIMS implementation strongly preferred.
• Good communication and documentation skills required.
• Direct laboratory or laboratory project management experience preferred.
• Experience with computer system validation is a plus.

Skills

• Experience communicating technical information to non-technical audiences.
• Demonstrated ability to work in a matrix environment with little direction.
• Ability to challenge status quo.
• Ability to recognize unusual or unexpected results, and resolve or escalate issues, if necessary.
• Develops solutions to issues of low to moderate complexity by collaborating with internal groups including IT.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Experience with implementation of Electronic Laboratory Notebook is a plus.

LOCATION

Remote - This position can be filled from any location worldwide.

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:$105,500.00to$131, Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Target Bonus on Base:7.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect - Appreciative of others
  • Integrity - Guided by our mission
  • Care - Empathetic to patients
  • Quality - Committed to excellence
  • Creativity - Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.