Director of Quality Assurance

RBW Consulting; Indiana; Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Leadership

Strategic thinking

Problem-solving

Communication

Decision-making

Formation

Bachelor's degree

Advanced scientific/engineering degree

Description du poste

Director of Quality Assurance | Pharmaceutical Manufacturing

We're currently seeking an experienced Director of Quality Assurance to lead Quality Systems, Clinical Quality and Manufacturing Quality within a growing pharmaceutical organization.

This is a senior leadership opportunity for a quality professional who can drive GxP compliance, quality strategy and continuous improvement across development, manufacturing and commercialization.

Key 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

About you:

• Bachelor's degree required; advanced scientific/engineering degree preferred
• 7+ years' experience within 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, communication and decision-making skills