Senior Director, QC & Analytical Development Strategy

MedPharm; North Carolina; On-site; USD 180,000 - 250,000; Full time

Job summary

MedPharm is seeking a Sr. Director, Quality Control and Analytical Development to provide strategic and operational leadership across the site QC and Analytical Development Laboratories.

You will drive cGMP adherence, oversee method development, validation, release, and analytical testing, and partner with cross-functional teams to meet client programs. You will manage budgets, schedules, and CRO relationships, while coaching staff, guiding recruitment, and ensuring audit readiness for

Qualifications

• Bachelor’s degree with 15+ years of experience or higher degrees with required years.
• Experience in GMP, biologics, gene and/or cell therapy QC and control strategy.
• Experience leading client site visits, audits, and regulatory inspections.

Responsibilities

• Develops and implements QC/Analytical Development strategy and roadmap.
• Leads and develops the QC and Analytical Development team with clear priorities.
• Oversees Analytical Development operations including method development/validation.
• Oversees QC operations including testing, release, stability, and monitoring.
• Manages CROs for method transfer and compliance.
• Supports client visits, audits, and regulatory inspections.
• Ensures budgets, timelines, and performance targets are met.
• Ensures cGMP compliance and audit readiness across areas.
• Leads technology transfers and improvements for compliant methods.
• Coaches and guides staff; participates in recruitment and retention.

Skills

Leadership

Collaboration

Program management

Organizational skills

Communication

Quality mindset

Problem solving

Negotiation

Education

Bachelor’s Degree in Chemistry/Biochemistry/Microbiology

Master of Science in related discipline

Ph.D. in Science

Job description

MedPharm is seeking a Sr. Director, Quality Control and Analytical Development to provide strategic and operational leadership across the site QC and Analytical Development Laboratories.

You will drive cGMP adherence, oversee method development, validation, release, and analytical testing, and partner with cross-functional teams to meet client programs. You will manage budgets, schedules, and CRO relationships, while coaching staff, guiding recruitment, and ensuring audit readiness for