Manager, Lab QC

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.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

The Manager of Laboratory QC is responsible for management of Quality Control of projects, assignments, training and staff. The Mgr, Lab QC applies laboratory quality control experience and extensive knowledge of process review into practical quality solutions for the organization. The Mgr, Lab QC evaluates, monitors, and systematically recommends corrective actions of procedures and processes. Professionally conducts reviews with a high level of attention to detail and communication that yields quality results. Have experience in and perform work in accordance with 21CFR58 GLP and ICH E6 Guideline for Good Clinical Practice for bioanalytical laboratory services. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development, rewarding and disciplining employees; recruiting; addressing employee relations issues and resolving problems.

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RESPONSIBILITIES

• Manage the Quality Control (QC) support to operations. Responsibilities include planning, assigning, and directing work;
• appraising performance and guiding professional development, rewarding and disciplining employees; recruiting; addressing
• employee relations issues and resolving problems. Approve actions on human resource matters.
• Manage the review and development of technical and QC SOPs to ensure compliance with appropriate regulations.
• Lead QC staff meetings and discuss findings and recommendations for resolving non-compliance.
• Work closely with operation individuals to improve quality systems.
• Communicate progress and strategic planning to IQVIA management in clear and concise appraisal with recommendations.
• May perform QC review of Reports, Sample Login binders, run binders, Extraction paperwork, Lab notebooks, and data
• tables. Actively participate in QC educational programs: in-house workshops, presentations on current QC issues, QC training
• and QC Seminars for all new employees, etc.
• Track and report deviation trends to management.
• Utilize root cause analysis to evaluate all systems for gaps, recommend action and professionally communicate to
• management the analysis to continually improve quality.
• Design, develop and implement new QC procedures.
• Demonstrate continuous self-motivated quality development.
• Proactively take steps to improve quality systems.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Laboratory experience in a GLP environment.
• Knowledge of word-processing, spreadsheet, and
• database applications.
• Knowledge of GLP regulations and guidelines and
• advanced quality review techniques..
• Strong interpersonal skills.
• Excellent problem solving skills.
• Effective organization, communication, and team
• orientation skills.
• Ability to initiate assigned tasks and to work
• independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working
• relationships with coworkers, managers and clients.
• Ability to manage staff
• Strong training capabilities.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• 7 years’ relevant experience in a quality / laboratory environment, including GLP and/or Quality Assurance experience
• Understands basic management approaches such as work scheduling, prioritizing , coaching and process execution.
• Bachelors Degree
• Equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS

• May be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools and equipment.
• Use of keyboard requiring repetitive motion of fingers.
• Regular sitting or standing for extended periods of time.
• Occasional travel.

EEO Minorities/Females/Protected Veterans/Disabled

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

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.