Associate Manager, Biologics Wet Laboratory

JOB OVERVIEW

Responsible for supervising a team of laboratory staff. Assists with administration of laboratory testing in accordance with applicable regulations governing clinical laboratories.

RESPONSIBILITIES

• Responsible for supervising a team of lab staff and ensuring effective operational delivery.
• Responsible for setting day to day operational activities for the team with a focus on daily delivery.
• Under the mentorship of management, responsible for hiring, training, and performance management of staff.
• Supervises the daily activities of assigned laboratory work group(s) through appropriate delegation, technical skills training, and work supervision. Meets regularly with staff and senior management to discuss and resolve workload and technical issues.
• Screens and assigns workload. Plans, prioritizes, and assigns tasks and projects.
• Responsible for monitoring of inventory of reagents and supplies to ensure adequate levels for deliverables. Ensures spend is within approved budgetary amount.
• Responsible for ensuring activity in the team meets safety guidelines. Drives individual accountability for safety across the team. Identifies opportunities for improvements in safety.
• Responsible for the review of laboratory metrics to identify initiatives as well as establish additional metrics such as cost savings that are associated with process improvement initiatives.
• Partners with stakeholders on process improvement initiatives to present projects and ensure that goals are met.
• Independently identifies and evaluates vendor platforms to that may help meet goals of the initiatives.
• Determines resourcing needs to ensure effective delivery.
• May act as a backup in any area of daily laboratory operations.
• Responsible for ensuring operations meet quality guidelines.
• Ensures timely and appropriate resolution of CAPA and quality incidents, quality and compliance metrics, root cause analysis and improvement.
• Ensures policies, practices and procedures are understood and followed by direct reports, customers, and stakeholders.
• Assists in establishment and revision of laboratory policies and procedures. Maintains appropriate control and quality assurance procedures. Ensures compliance with safety requirements.
• Keeps abreast of new technical developments. Assist with implementation of new tests, equipment, programs and/or procedures in the assigned area(s) as needed. Contribute to continuous improvement initiatives to increase quality of services and operational efficiency.
• Fosters a unified culture and facilitates collaboration, cooperation, sharing of information and teamwork. Participates in 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.
• 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 Technical Field Preferred
• High School Diploma or equivalent Required
• 4 years of experience in a regulated laboratory environment Required

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Demonstrated ability to train and mentor others, as well as navigating challenges in operational and people matters.
• Ability to assess and prioritize multiple tasks, projects and demands.
• Strong understanding of specific area of responsibility. Understanding of operations and methods. Knowledge of study set up and cross functional/system dependencies.
• In depth knowledge of testing procedures and applicable laboratory testing regulations
• 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.
• In depth knowledge of clinical testing procedures and applicable laboratory testing regulations.
• Good written and oral communication skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Applicable certifications and licenses as required by local regulations.

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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. q2-solutions-eoe

Q² Solutions’ ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding COVID-19 vaccination status.q2-solutions-covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $75,400.00 - $113,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.