Senior Director, Laboratory Operations
Q² Solutions is a wholly owned subsidiary of IQVIA and a leading clinical trial laboratory services organization with bioanalytical, genomics, vaccines, flow cytometry, anatomic, pathology, immunoassay, companion diagnostics and central laboratory services with secure, enterprise-wide biospecimen and consent management solutions.
We are seeking a dynamic global leader who will be based in either Europe, Asia, or the US with experience in running laboratory operations, driving harmonized processes, and brings sound knowledge of regulatory and quality related to GCP. The ideal candidate will have customer experience and the ability to execute strategic decisions. The Sr. Director of Global Laboratory Operations will direct, administer, and coordinate activities of Laboratory operations in assigned regions – Europe, Asia, and the US, and will primarily be responsible for operational and on time delivery of patient results, collaborating with our scientific teams, as well as headcount and financial planning, and quality of services delivered. In conjunction with Vice President, Global Central Lab Operations, other regional general managers, and global functional managers, the Sr. Director will formulate short and long-term plans, objectives, and policies. Ideally, the candidate will be based close to one of our main laboratory facilities.
- Direct operations for Laboratory operations in an assigned regions to ensure operational profitability and the delivery of quality services to clients.
- Focus on customer satisfaction and ensure activities are put in place to maintain and improve customer satisfaction levels.
- Interact with clients to address clients’ operational issues and ensure satisfaction with services.
- Develop policies, practices, and standards to minimize and manage business risk to the Company and customers.
- Develop, monitor, and implement regional budgets and pricing programs. Maintain financial oversight of operations in assigned regions.
- Assure implementation and operational integration of Global Laboratory goals and objectives in regions as directed by senior management.
- Develop and implement region’s strategic and tactical initiatives.
- Standardize laboratory instrumentation and testing.
- Drive global projects and initiatives.
- Ensure test costings are kept up to date, and that headcount is monitored in all regions.
- Decide whether feasibility, validations and technology transfers should be performed and where when Global Technical.
- Ensure there is continuous improvement via Lean projects, proficiency testing and quality improvement projects.
- Encourage sharing of ideas and projects between the global teams through team meetings and 1:1s.
- Collaborate and communicate with global teams and colleagues across the business:
- Laboratory and Lab Tech Support
- Pre-analytical and SMAS
- Laboratory Standardization
- Translational Science Laboratory
- Scientific Review
- Strategic Pricing
- Set up/ Project Management/ Data Management
- Quality Assurance
- Systems Compliance
- Information Technology
- Finance / FP&A teams
- Vendors as necessary
Regular meetings with:
- Direct reports and APAC team
- Global counterparts from other areas of the business
- Site heads and Associate Director, Talent Acquisition
- Global Lab Director and Sr Director, Global Harmonization
Harmonize processes/SOPs – decision maker when there is lack of consensus.
- Provide technical advice and direct global discussions.
- Assist Laboratory Medical Directors
- Review issues arising from QC management meetings for all regions.
- Final approval of test code inactivation/retiral requests in TCWA
- Ensure globally aligned responses to QI’s and complaints and to CAP and ISO 15189 findings.
- Ensure global response for CAP/EQAS failure investigations/reports where appropriate.
- Promote global support from vendors.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- Understanding of sample handling and preparation.
- Proficiency with relevant laboratory techniques.
- Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.
- General awareness of the broader drug development process and the interaction of method development in that process.
- Ability to troubleshoot laboratory equipment and resolve process issues.
- Basic understanding of requirements under relevant regulatory standards for assigned work area.
- Good computer skills including proficiency with Microsoft Excel, PowerPoint, and Word.
- Capable of handling multiple tasks simultaneously.
- Strong attention to detail and accuracy.
- Effective organizational and interpersonal skills.
- Effective communication and presentation skills.
- Ability to work closely with other members of the laboratory.
- Ability to maintain a minor degree of independence to complete assigned tasks and projects.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree in business administration or science-related field required.
- 10-15 years relevant industry experience
- Knowledge of operational aspects of clinical laboratory service delivery
- Knowledge of regulatory and regional policies and practices in clinical laboratory environment
- Excellent analytical skills to resolve issues in a variety of complex situations.
- Excellent verbal and written communication skills with a focus on customer service
- Strong presentation and organizational skills
- Strong negotiating skills
- Strong leadership skills
Q² Solutions,IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers