Director- Global Clinical Trials Kit Production

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. 

Job Overview

Direct the global planning, strategy, operations and quality of Clinical Trials kit production and delivery. Provide related regulatory and production expertise, guidance and strategic direction to staff, internal and external customers.

Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

Essential Functions

• Responsibilities of this role span across Kit Production, Logistics and Inventory Control as required

• Provide or support strategic direction for global kit production

• Ensure strategic initiatives are executed in a timely manner in accordance with the project plan

• Plan or manage allocation of Clinical Trials Materials (kit production) resource, including project initiatives / assignments

• Ensure global standard operating procedures are developed to comply with international and domestic import, export, transport and packaging regulatory processes

• Maintain external network of industry kit production, logistics, and regulatory contacts

• Develop and maintain good communications and working relationships with internal and external clients, regulatory agencies and related companies

• Keep abreast of current data, trends, regulations, developments and advances in area of expertise

• Ensure vendors are managed in a manner that fosters continuous improvement

• Manage staff in accordance with organization’s policies and applicable regulations

Qualifications

• 5+ years relevant experience including 3 years experience in a production leadership capacity

• Demonstrated experience in Lean Six Sigma manufacturing environment

• Comprehensive knowledge of international import/export regulations and procedures.

• Effective organizational, communication and interpersonal skills.

• Skill extracting relevant data to measure performance indicators and proactively planning

• Ability to lead and motivate high-performing teams.

• Ability to analyze work processes to drive efficiency and scalability.

• Ability to manage multiple projects and ensure that they are performed in a quality manner.

• Strong organizational and problem-solving skills.

• Ability to effectively delegate work.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.