Manager, Quality Clinical Svc

PCI Pharma Services•Rockford, IL

22h•Onsite

About The Position

Plans, directs, and coordinates Quality activities of a designated Clinical Customer Focused Team to ensure that goals and objectives of the team are accomplished within prescribed time frames and in budget. Select, supervise, empower, coach, develop and retain a team of qualified individuals including: Quality Specialist(s) and Quality Coordinator(s) while partnering with the Sr. Clinical Project Manager to ensure that we deliver a quality product, on time. Drives project success through active leadership to provide PCI a competitive advantage in long-term quality customer management.

Requirements

Bachelor's Degree in a related field and/or 7-10 years related experience and/or training.
Statistical and Advanced Mathematical Skills
Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Nice To Haves

Project Accomplishment Experience

Responsibilities

Select, supervise, empower, coach, develop and retain a team of qualified individuals through effective employee development, performance management, succession planning and recognition.
Ensure the appropriate team structure is in place by performing workload analysis to manage headcount and to ensure we deliver on customer and business commitments.
Establish quality team and individual goals and objectives in alignment with Clinical Customer Focused Team goals and customer requirements.
Ensure strong alignment and coordination with other business units and functional groups. Collaborate on best practices with other Clinical Quality Managers and leadership.
Facilitate the daily quality team performance to ensure goals and objectives are met and to build a culture of safety, quality, performance, customer service and continuous improvement.
Manage the training and development of the team including cross training initiatives and on-boarding of new employees to the team.
Provide support for customer audits, visits and conference calls. Work with Clinical Customer Focused Team to develop systemic corrective actions to any deviations noted.
Oversee investigations, consumer complaints, CAPAs, DEA activities, NMR issues, etc.
Collaborate with the other team members to manage the team performance metrics and customer scorecard.
Collaborate with the appropriate Account Executive and Sr. Project Manager to coordinate and facilitate the customer Quarterly Business Review’s.
Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design.
Adherence to PCI and cGMP policies, procedures, rules and regulations.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor.