Global Quality Executive Director - Patient Impact

PCI Pharma Services; Tennessee; On-site; USD 200,000 - 300,000; Full time

Job summary

PCI Pharma Services is seeking an Executive Director, Quality to lead strategic and operational quality across the Bedford Development & Manufacturing campus. This role oversees QA, QC, Validation, and the QMS, balancing compliance with patient safety and production needs.

As a senior Site Leadership Team member, you will drive long-term quality strategy, talent development, and regulatory readiness while ensuring Right-First-Time manufacturing and robust quality systems across global standards.

Qualifications

• 15+ years in a similar org with senior management exp.

Responsibilities

• Develop and communicate a strategic Quality vision across PCI.
• Ensure QMS and systems maximize Right-First-Time manufacturing.
• Maintain inspection readiness and regulatory compliance.
• Lead QA, QC, & Validation across Development & Manufacturing.
• Interface with Regulatory Agencies for inspections and submissions.
• Develop quality budget and manage its execution.

Skills

Strategic leadership

Quality management

Regulatory knowledge

Cross-functional collaboration

Inspection readiness

Data analysis

Education

Bachelor's degree

Advanced degree desired

Tools

eQMS

Process mapping tools

Job description

PCI Pharma Services is seeking an Executive Director, Quality to lead strategic and operational quality across the Bedford Development & Manufacturing campus. This role oversees QA, QC, Validation, and the QMS, balancing compliance with patient safety and production needs.

As a senior Site Leadership Team member, you will drive long-term quality strategy, talent development, and regulatory readiness while ensuring Right-First-Time manufacturing and robust quality systems across global standards.