Director of Quality

About the role

We are seeking an experienced leader to direct our operational microbiology teams. This role is responsible for leading the strategic direction and global compliance of microbiology programs across multiple manufacturing sites. You will be the subject matter expert (SME) and process owner, ensuring our quality systems meet rigorous regulatory standards and business objectives.

Key Responsibilities

• Lead, mentor, and develop a team of managers and scientists to achieve high performance and robust quality output.
• Act as the global process owner, overseeing the implementation of procedures for microbiology programs.
• Provide technical SME guidance in key areas including: controlled environment qualification, water systems, endotoxin and bioburden method validation, and contamination control systems.
• Collaborate cross-functionally with Operations, R&D, and Quality to support business projects, new product development, and transfers.
• Represent the department as the primary microbiology expert during regulatory inspections (FDA, ISO) and customer audits.
• Report on program performance and key metrics to senior leadership.

Qualifications

• Education: Bachelor's degree required; Master's in Microbiology or related discipline preferred.
• Experience: Minimum of 10 years in a regulated industry (medical device preferred), with at least 5 years in a leadership capacity.
• Expertise: Proven experience with FDA CFR, ISO 13485, and applicable microbiology standards (e.g., ISO 11737, ISO 14644, USP).
• Skills: Strong strategic thinking, team development, cross-functional collaboration, and excellent technical writing and communication skills.