Apply on Employer Site

PCI Pharma Services · 20 hours ago

Manager, Quality Clinical Svc

Rockford, IL

Full-time

Onsite

Mid, Senior Level

$78K/yr - $87K/yr

7+ years exp

PCI Pharma Services is committed to delivering life-changing therapies and building a better tomorrow. The Manager of Quality Clinical Services will lead a Clinical Customer Focused Team to ensure quality activities are effectively planned and coordinated, driving project success and maintaining compliance with quality standards.

BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical

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 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

Qualification

Quality AssuranceStatistical SkillsAdvanced Computer SkillsProject ManagementContinuous ImprovementTeam LeadershipProblem SolvingCommunication Skills

Required

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