Manager, Quality Clinical Svc

• 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 of 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

• 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

Project Accomplishment Experience

• paid time off
• health insurance coverage (including dental and vision)
• a flexible spending account
• a 401(k) plan
• eligibility for an 10% annual performance bonus