Executive Leader, Quality Control & Analytical Development

MedPharm Ltd; Durham (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

MedPharm Ltd in Durham, NC seeks a Sr. Director of Quality Control and Analytical Development to provide strategic leadership for the site QC and Analytical Development Laboratories, drive GMP-compliant methods, and align with global quality strategy.

You will build and guide a high-performing team, oversee method development/validation, coordinate with CROs, manage budgets, schedules, and audits, and ensure readiness for inspections.

Qualifications

• Bachelor’s degree with 15+ years in QC/Analytical Development leadership.
• M.Sc. with 13+ years of experience in related field.
• Ph.D. with 11+ years of experience in science.
• 12+ years of people management, leadership, and team management experience.
• Technical and regulatory understanding and experience of biologics, gene, and/or cell therapy QC with an understanding of control strategy.
• Experience leading client site visits, audits, and regulatory inspections.

Responsibilities

• Develops strategy and roadmap for Quality Control and Analytical Development with the overall Global Quality Strategy.
• Builds, develops and leads the QC and Analytical Development team with clear priorities and career development.
• Provides strategic decision-making; prioritizes deliverables to meet site and compliance objectives.
• Oversees Analytical Development operations including developing, qualifying, and validating analytical methods.
• Oversees QC operations including In Process Testing, Bulk Release and Stability Testing, Microbiological Testing, and Environmental Monitoring.
• Oversees contracted testing labs (CROs) for method transfer and compliance.
• Supports and participates in client visits, audits, and regulatory inspections.
• Ensures budgets, timelines, schedules and performance requirements are established and met.
• Assures all areas comply with cGMP and are audit-ready.
• Oversees the development and implementation of standards, methods and procedures for testing and evaluating quality and safety of products.
• Manages technology transfers and method improvements for reliable, compliant methods.
• Administers company policies affecting employees.
• Participates in recruitment and retention strategies; addresses performance gaps and HR coordination.

Skills

People management

GMP compliance

Regulatory inspections

Analytical development

Quality systems

Leadership

Education

Bachelor’s Degree in Chemistry/Biochemistry/Microbiology or related field

M.S. in a related discipline

Ph.D. in Science

Job description

MedPharm Ltd in Durham, NC seeks a Sr. Director of Quality Control and Analytical Development to provide strategic leadership for the site QC and Analytical Development Laboratories, drive GMP-compliant methods, and align with global quality strategy.

You will build and guide a high-performing team, oversee method development/validation, coordinate with CROs, manage budgets, schedules, and audits, and ensure readiness for inspections.