Senior Director – QA & Product Development (Pharma)

Job Summary

We are seeking an experienced Quality Assurance, Quality Control, and Product Development leader to oversee quality systems, regulatory compliance, and product development programs.

This role ensures compliance with global regulatory standards including:

• U.S. Food and Drug Administration
• European Medicines Agency
• International Council for Harmonisation
• ISO 13485

The ideal candidate will lead cross-functional teams, drive quality excellence, and guide product development from concept through commercialization.

Key Responsibilities Quality Leadership

• Develop and implement company-wide quality management strategies
• Lead, mentor, and grow QA, QC, and Development teams
• Ensure compliance culture and operational efficiency

Product Development & Quality

• Apply Quality by Design (QbD) principles
• Oversee design controls, validation, and verification
• Lead product lifecycle from concept to commercialization

Manufacturing & Continuous Improvement

• Drive continuous improvement initiatives
• Conduct root cause analysis and CAPA
• Utilize SPC and quality metrics

Supplier Quality Management

• Manage supplier qualification and audits
• Monitor supplier performance and compliance

Regulatory Compliance

• Prepare and review regulatory submissions
• Interface with global regulatory agencies
• Ensure compliance with GMP and global standards

Audits & Quality Systems

• Maintain audit readiness (internal & external)
• Ensure compliance with GMP and 21 CFR regulations

Metrics & Reporting

• Define and track KPIs
• Report quality performance to leadership

Cross-Functional Collaboration

• Partner with R&D, Manufacturing, Engineering, and Operations
• Support client-facing product development initiatives

Education

• Bachelor’s, Master’s, or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Experience

• Minimum: 10+ years in Quality, Regulatory Affairs, or Product Development
• Preferred: 15–20 years in pharmaceutical or biotech industry
• Proven experience in product commercialization and regulatory compliance

Required Skills

Quality Assurance & Quality Control systems

• Regulatory submissions and compliance
• GMP and regulatory audits
• Product development lifecycle management
• CAPA, SPC, and quality metrics
• System validation and quality systems implementation

Regulatory Knowledge

• Strong understanding of 21 CFR (FDA)
• Global regulatory frameworks and submission pathways
• CMC requirements (small molecules, biologics, etc.)

Leadership Responsibilities

• Build and manage high-performing teams
• Oversee departmental budget and operations

Growth Opportunity

High-performing candidates will have opportunities to advance into senior executive leadership roles.

Pay: $30.00 per hour

Work Location: In person