Director of External Quality (Remote)

About the role

We are seeking a Director of External Quality to lead a team of quality professionals overseeing external manufacturing of our products and devices. This remote position serves as the subject‑matter expert on external quality assurance, manufacturing quality systems, and regulatory expectations, representing the company in external forums.

Key responsibilities

• Lead and develop a small team of Quality Assurance professionals responsible for activities at external manufacturing sites.
• Provide quality oversight across molding, manufacturing, assembly, testing, packaging, storage, and distribution.
• Ensure all processes comply with approved methods, global GMP, MDCP regulations, and company policies.
• Act as the external quality expert, driving cross‑functional initiatives to improve quality and business processes.
• Represent the organization in industry forums and manage performance reviews, objectives, and development plans for direct reports.

Required profile

• Four‑year degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Pharmacy, Chemical Engineering).
• At least 12 years of experience in the pharmaceutical or medical‑device industry with deep knowledge of quality systems and regulatory requirements.
• Proven experience participating in regulatory inspections and familiarity with domestic and foreign regulations.
• Strong interpersonal and leadership abilities to work across functional boundaries.

Required skills

• Good knowledge of GMP (Good Manufacturing Practice).
• Experience with MDCP (Medical Device Clinical Performance) regulatory requirements.
• Regulatory inspection participation.
• Fluent written and spoken English.