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.

JOB DESCRIPTION:

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.

ESSENTIAL DUTIES AND 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.

• Supervises 1-10 employees

QUALIFICATIONS:

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.

Pr ef e r r e d:

• Project Accomplishment Experience

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled