Director of External Quality (Remote)

About the role

The Director, External Quality leads a team of quality professionals responsible for ensuring compliance and quality oversight across external manufacturing sites. This remote position serves as the subject‑matter expert on external quality assurance (EQA), manufacturing quality systems, and regulatory expectations, representing the company in external forums.

Key responsibilities

• Lead and develop a small team of Quality Assurance professionals, conducting regular 1‑on‑1s and performance reviews.
• Provide quality oversight for molding, manufacturing, assembly, testing, packaging, storage, and distribution at external entity (EE) sites.
• Ensure all products are produced and tested according to approved processes, global GMP, MDCP regulations, and company policies.
• Act as SME for EQA and manufacturing quality systems, technology platforms, and external entity management.
• Represent the company in external forums and drive cross‑functional initiatives to optimize quality and business processes.
• Collaborate with other functions to continuously improve quality management effectiveness and efficiency across the external network.

Required profile

• Minimum four‑year degree in a scientific or engineering discipline (e.g., Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering).
• At least 12 years of experience in the pharmaceutical and/or medical device industry with deep knowledge of quality systems, quality assurance, and quality control.
• Extensive experience with global GMP and MDCP regulatory requirements and participation in regulatory inspections.
• Strong interpersonal and communication skills, with the ability to work across functional boundaries.

Required skills

• GMP compliance
• MDCP regulatory knowledge
• Quality Systems implementation
• Regulatory compliance and inspection experience