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 for key strategic accounts.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Coordinate with Global Program Managers to establish a Global Relationship Management Team (RMT) ensuring strong support both internally and externally.
• Participate in weekly RMT meetings, continually evaluate team capacity and structure to support Client provided forecast and timelines as it relates to Quality across global PCI sites.
• Maintain awareness of all projects, contacts, programs and operational/client issues, escalation, and concerns.
• Develop standardized Quality expectations, metrics, and ways of working to ensure harmonization across sites and achievement of established timelines.
• Lead Quality efforts in the associated periodic (weekly/monthly/quarterly) client reviews.
• Maintain understanding of key aspects within Technical/Quality Agreements and appropriate Supply Chain documents.
• Ensure the appropriate team structure is in place by performing routine workload analysis to manage headcount and to ensure we deliver on customer and business commitments.
• Ensure strong alignment and coordination with other teams and functional groups. Collaborate on best practices.
• 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, NONC issues, etc.
• Intricately involved in global and site-specific procedures and processes to ensure site harmonization from a Quality perspective.
• Collaborate with the other team members to manage the team performance metrics and customer scorecard.
• Use critical thinking skills, logic, and ingenuity to resolve issues and unique challenges while remaining within cGMP guidelines and PCI procedures and policies.
• Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design.
• Adherence to PCI and cGMP policies, procedures, rules, and regulations.
• Host and manage Customer Quality visits.
• This position may require overtime and/or weekend work.
• This position may require travel to other PCI locations and / or client sites.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance at work is an essential function of this position.
• Performs other duties as assigned by Manager/Supervisor.

QUALIFICATIONS:

Required:

• Bachelor's Degree in a related field and/or 7-10 years related experience and/or training.
• Robust knowledge of CFR's 210/211
• 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.
• 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.

Preferred:

• Strong knowledge and understanding of the EU, PICs, WHO and other relevant GMP and ICH
• guidelines and regulations.
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to display excellent time management skills.
• Ability to work independently and/or as part of a team.
• Experience with Clinical Quality, and Global Quality requirements.

#LI-RS1

Join us and be part of building the bridge between life changing therapies and patients.

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.