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PCI Pharma Services · 1 day ago

Manager, Quality Accounts

Rockford, IL

Full-time

Onsite

Mid, Senior Level

$78K/yr - $87K/yr

5+ years exp

PCI Pharma Services is a company focused on life-changing therapies and global impact. They are seeking a Manager for Quality Accounts to lead a designated Customer Focused Team, ensuring that quality goals and objectives are met while developing and retaining a qualified team.

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 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 Quality Account 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 Customer Focused Team to develop systemic corrective actions to any deviations noted

Oversee investigations, consumer complaints, CAPAs, DEA activities, NMR issues, etc. as needed

Collaborate with the other team members to manage the team performance metrics and customer scorecard

Collaborate with the appropriate Account Executive and Business Unit Manager to coordinate and facilitate the customer Quarterly Business Review’s

Lead cross-functional Quality Improvement Projects which drive harmonization and improvement within the organization

Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by design adherence to PCI and cGMP policies, procedures, rules and regulations

Supply agreement adherence management

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 and submits batch records, accountability reports and necessary documentation to customers to facilitate product release

Performs finish product batch release of approved production lots

Performs other duties as assigned by Manager/Supervisor

Qualification

Quality AssuranceTeam LeadershipProject ManagementAdvanced Computer SkillsProblem SolvingMathematical SkillsContinuous ImprovementCommunication Skills

Required

Bachelor's Degree in a related field and/or 5-10 years related experience and/or training

College Level 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

Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables