Job Description

Associate Manager, Metrology



Primary Location: Durham, North Carolina, United States Full time R1168708 Date Posted: 01/12/2021

Job description

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 organizations clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Overview

Responsible for supporting the proactive execution of instrumentation and metrology related programs. Ensures effective supervision and coordination of a team of individuals to delivery on related programs.

Responsibilities

* Supervises junior level professionals, senior support level employees, entry level technical supervisors or a combination of these groups.
* Sets day to day operational activities for the team with a focus on daily delivery.
* Responsible for hiring, training, performance management, and development of staff with mentoring and coaching from management.
* Determine resourcing needs to ensure effective delivery.
* Responsible for ensuring operations meet quality guidelines.
* Ensure 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.
* Supervise the daily activities of assigned work group(s) through appropriate delegation, technical skills training, and work supervision. Meet regularly with staff and senior management to discuss and resolve workload and technical issues.
* Plan, prioritize and assign tasks and projects. Counsel, train and coach laboratory staff. Monitor work, develop staff skills and evaluate performance.
* Assist in establishment and revision of policies and procedures.
* Assist with implementation of new tests, equipment, programs and/or procedures in the assigned area(s) as needed.
* Foster a unified culture and facilitate collaboration, cooperation, sharing of information and teamwork. Participate in initiatives to improve employee engagement to positively impact operational results, customer satisfaction and employee retention.
* Partners cross functionally to identify new equipment needs, budgetary requirements, and RFP's.
* Responsible for installation and qualification of new equipment, instrumentation, and controlling software according to standard operating procedures, as appropriate. Coordinates and oversees vendor installation and qualification, as needed.
* Ensure the team follows proper documentation procedures to meet quality guidelines.
* Supports the team on escalated troubleshooting of equipment and instrumentation.
* Partners with Facilities Management to ensure suitability of equipment and instrument infrastructure.
* Ensures efficient and timely repair of disabled analytical instruments and laboratory equipment to insure minimal downtime.
* Responsible for external vendor management and oversight.
* Establish Preventative Maintenance (PM) programs for new analytical instruments and laboratory equipment while maintaining and updating existing PM programs, inclusive of risk assessment and gap analysis.
* Accountable for ensuring equipment and instrumentation is on-boarded and qualified with applicable standards.
* Play an active role in the development of business continuity plans, preparation, and support.
* Create and maintain SOPs for instrumentation/metrology. Partner with junior level staff to review drafted SOPs.
* Coordinates after-hours coverage of all systems to ensure effective emergency response.
* Acts as project manager to support lab initiatives, such as facility changes and new instrumentation evaluations.
* Responsible for contributing to the development and tracking of key functional metrics.
* Serves as a subject matter expert to support the audit and inspection process and responds directly to inquiries.
* Responsible for training employees on equipment and instrumentation usage.
* May provide support to remote facilities on preventative maintenance and/or repair of analytical instruments via telephone. May be required to visit remote facilities on an occasional basis to provide support.
* Performs work in accordance with applicable regulatory requirements.
* Responsible for identifying and driving opportunities for process improvement, supporting six sigma, quality, and safety initiatives.

Minimum required education and experience

* Bachelor's degree and 4 years relevant experience; or equivalent combination of education, training and experience
* Applicable certifications and licenses as required by country, state, and/or other regulatory bodies required

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 IQVIAs Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.