Director, Global QMS Position Available In Wake, North Carolina

Director, Global QMS LabConnect, LLC – 3.0

Raleigh, NC Job Details Full-time Estimated:

$114K – $149K a year 1 day ago Benefits AD&D insurance Paid holidays Disability insurance Health insurance Paid time off 401(k) matching Opportunities for advancement Qualifications Microsoft Word Biology Microsoft Excel Microsoft Outlook Medical Technology Word processing Accounting software Laboratory experience English Microsoft Office Bachelor’s degree Continuous improvement Accounting Computer skills Senior level Leadership Communication skills 10 years Full Job Description Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions. Summary The Director, Global QMS, is the owner of the global quality management system at LabConnect and all its subsidiaries. He/she is responsible for overseeing all quality activities within LabConnect’ s global operations teams to ensure adherence to the QMS and applicable regulations. This role ensures that all central laboratory processes meet industry standards, compliance regulations, and achieve customer satisfaction. This role ensures LC has a robust framework of policies and procedures governing all applicable GxP processes and supports the VPQA in building and fostering a culture of Quality by evaluating and maturing the effectiveness of the QMS. The Director will work closely with the Global Operations leadership team and other departments to drive continuous improvement and best in class quality standards. Responsibilities Develop and implement global QMS policies and procedures to ensure compliance with regulatory requirements and industry standards. Including but not limited to Doc control, Issue management and CAPA, Change control, Training etc. Build, Lead and mentor a team of quality professionals, providing guidance and support to ensure high performance and professional development. Collaborate with cross-functional teams to identify and address operational quality issues, implement corrective actions, and drive continuous improvement initiatives. Ensure all central laboratory processes, including kit building and sample handling, testing, and reporting, adhere to industry standards and best practices. Oversee all issues/QEs and ensure their management and timely resolution with applicable CAPAs. Identify, assess and report on trends and KPIs that measure the QMS and continuous improvement. Collaborate with Quality Compliance for internal and regular audits and inspections to monitor compliance and identify areas for improvement. Perform audits when necessary. Support Quality initiatives as assigned. Manage relationships with regulatory bodies as needed and ensure timely and accurate reporting of operational metrics and compliance status internally. Develop and deliver training programs to enhance quality awareness and competency across the organization. Oversee investigations into operational quality incidents, root cause analysis, and implementation of corrective and preventive actions (CAPA). Ensure an effective Issue management process, with focus on critical issues.

Education and Qualifications:

Education:

Bachelor’s degree in scientific discipline,(Biology, Chemistry, Medical Technology) required. Advanced degree in scientific discipline is preferred.

Experience:

Minimum 10 years of experience in quality and operations within the central laboratory, biotech or pharma industry with expertise in GxPs and managing regulatory compliance including interaction with Health Authorities. Required Skills Strong knowledge of global regulatory requirements (e.g., CLIA, CAP, ISO 15189, GxP) and industry standards. Proven experience in leading and managing quality teams in a global, multi-site environment. Very strong communication and collaboration skills, with timely decision making and risk management. Excellent problem-solving skills and the ability to drive continuous improvement initiatives. Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Proficiency in operational management systems and laboratory information management systems (LIMS). Effective decision making and application of sound judgement in issue escalation to management with proposals and sense of urgency. Proficient in Microsoft Word, Excel, Outlook, and other company technological skills. Language Ability English required. Must possess the ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. The ability to write reports, business correspondence, and procedure manuals is needed. The ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public is also necessary. Math Ability The ability to apply advanced concepts of accounting is required. Reasoning Ability Handles detailed, complex concepts and problems, balances multiple tasks simultaneously, and makes rapid decisions regarding administrative and executive issues. Must display excellent analytical, reasoning and problem-solving skills. Computer Skills To perform this job successfully, an individual should have advanced knowledge of Microsoft Office applications, word processing software, spreadsheet software, accounting software and database software. Supervisory Responsibilities Manager, Specialist levels Read more below and get ready for your next great employment adventure! Some of the Perks our

LabConnectors Love:

Financial Security (base pay, 401k match and possible annual bonus eligibility) Health Benefits beginning on date of hire PTO plan plus 11 Paid Company Holidays and 1 day to Volunteer in your community Short and Long-Term Disability, Life and AD&D We celebrate our differences, which enrich our Culture We are a growing and global team which Values People First, Quality Focused, Customer Centered, Technology Driven and Accountability Always. In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities. We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world. It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.

Equal Employment Opportunity Posters:

https://www.dol.gov/agencies/ofccp/posters If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email or call +1(423)722-3155. For more information, visit www.labconnect.com