Manager, Quality Accounts

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

Plans, directs, and coordinates Quality activities of a designated 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:  Associate Quality Account Manager(s) and Quality Coordinator(s) while partnering with the Business Unit 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. 

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• 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.                                                                                                                                                                

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.