Director of Quality Assurance - GxP & Compliance Leader

RBW Consulting; Indiana; On-site; USD 140,000 - 190,000; Full time

Job summary

RBW Consulting is seeking a Director of Quality Assurance to lead Quality Systems, Clinical Quality and Manufacturing Quality within a growing pharmaceutical organization. The role focuses on GxP compliance, quality strategy and continuous improvement across development, manufacturing and commercialization.

This senior leadership position requires strategic thinking, strong regulatory experience and the ability to drive quality culture and budget management across internal teams and external

Qualifications

• 7+ years of experience in a regulated GxP/pharmaceutical manufacturing environment.
• Proven leadership and people management experience.
• Strong knowledge of pharmaceutical manufacturing and GxP requirements.
• Strategic thinker with excellent problem-solving and communication skills.

Responsibilities

• Lead Quality Systems, Clinical Quality and Manufacturing Quality.
• Provide strategic direction across CAPA, Change Control, Supplier Quality, Audits, Risk Management and Product Disposition.
• Lead regulatory inspection readiness and act as a key contact during FDA and international inspections.
• Oversee quality activities with CMOs, suppliers and third-party laboratories.
• Drive a strong quality culture and continuous improvement across the organization.
• Lead, develop and coach the Quality Assurance team.
• Manage quality strategy, metrics and departmental budgets.

Skills

Leadership

Strategic thinking

Problem-solving

Communication

Decision-making

Education

Bachelor's degree

Advanced scientific/engineering degree

Job description

RBW Consulting is seeking a Director of Quality Assurance to lead Quality Systems, Clinical Quality and Manufacturing Quality within a growing pharmaceutical organization. The role focuses on GxP compliance, quality strategy and continuous improvement across development, manufacturing and commercialization.

This senior leadership position requires strategic thinking, strong regulatory experience and the ability to drive quality culture and budget management across internal teams and external