Associate Director, Vaccines

JOB OVERVIEW

Responsible for the operation, leadership, direction, and administration of laboratory testing in accordance with applicable regulations governing clinical laboratories. Partners with executive and global leadership to establish strategy and ensure implementation to drive achievement of annual objectives and supporting long term success.

RESPONSIBILITIES

• Oversee the overall operations of the clinical testing function of the laboratory organization. Ensures that laboratory operations meet or exceed all applicable regulatory requirements.
• Oversees local lab operations and ensures global consistency and strategic/operational alignment.
• Ensures that the highest standards of quality and customer service are maintained.
• Collaborates with Quality Assurance staff on development and implementation of effective programs.
• Monitors outside proficiency testing program as required and take corrective action promptly when results are unsatisfactory.
• Establishes effective staff selection and training programs to ensure that qualified staff are hired and continuously trained in order to remain current on testing procedures.
• Ensures that laboratory staff are trained on and comply with safety procedures.
• Establish and implement procedures to ensure that the physical laboratory environment meet safety requirements.
• Participates in the development and implementation of the department's operating budget.
• Establishes standards for cost control and waste reduction.
• Monitors utilization patterns of services and advise on developing trends in clinical service needs.
• Keeps abreast of new technical developments.
• Implement new tests, equipment, programs and/or procedures in the department as needed.
• Lead continuous improvement initiatives to increase quality of services and operational efficiency.
• Fosters a unified culture and facilitates collaboration, cooperation, sharing of information and teamwork.
• Leads initiatives to improve employee engagement to positively impact operational results, customer satisfaction and employee retention.
• Manages staff in accordance with organization's policies and applicable regulations.
• Drives CAPA closure and resolution, quality compliance and metrics, oversight of quality incidents and resolution, root cause analysis and improvements.
• Drives a continuous improvement and quality-oriented culture.
• Partners with Sales and Assay Development on calls to scope RFP for turnaround time, recommends needs to meet client requests.
• Serves to resolve escalated and complex challenges with clients on sample logistics, stability, test results.
• Supports safety, quality, and 6S requirements and initiatives.
• Complies with company's procedures and applicable regulatory requirements.

MINIMUM EDUCATION REQUIRED AND EXPERIENCE

• Bachelor's Degree in a health sciences field Required.
• 10 years of experience in a regulated laboratory environment.
• 3 years of experience leading a team.
• Or equivalent combination of education, training, and experience.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• In depth knowledge of clinical testing procedures and applicable laboratory testing regulations.
• Preferred experience in ELISA and Hemagglutination Assays.
• Requires practical knowledge in leading and managing the execution of processes, projects, and tactics within one department or multiple related departments.
• Working knowledge of quality assurance and quality control principles and in-depth knowledge of company-specific program requirements.
• Knowledge of occupational safety and health rules and regulations.
• Excellent written and oral communication skills.
• Excellent client management and problem resolution skills.
• Excellent financial management skills.
• Effective mentoring and coaching skills.
• Strong operational focus.
• Ability to motivate a team to achieve shared goals within performance standards and budget.
• Ability to assess and prioritize multiple tasks, projects and demands.
• Ability to make effective and persuasive presentations on controversial or complex topics to clients, senior management, and other stakeholders.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Applicable certifications and licenses as required by local regulations.

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. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status