Hiring: Director Quality Company: Thermo Fisher Scientific Location: Middletown, VA Job Posted Time: 2026-09-10 07:40:48 Target Skills & Keywords : Regulatory Compliance About the job Experience: •10 years of quality / regulatory experience including at least 5 years of prior experience leading a quality / regulatory role. •At least 5 years of prior experience leading a quality / regulatory role. Required Skills: •Acts as Management Representative of the Quality System and official correspondent of the site to all regulators (including US FDA). Primary contact at the site for all audits (regulator, Notified Body and customer). •Serve as a member of the site leadership team, providing strategic direction and influencing business decisions to ensure quality, compliance, and operational excellence are integrated into site objectives. •Establish strategies and drives actions to ensure the Quality Management System is adequate and successfully implemented to remain in sustained compliance with applicable regulations and standards. •Lead and oversee site product quality, compliance, conformance to quality requirements and specifications, and customer quality requirements. Supports regulatory recalls and interaction with government agencies. •Directly interacts with customers and OEM partners in relation to quality agreements, and quality matters associated with provided products and services. •Champion risk-based decision making by overseeing quality risk management processes and ensuring risks are identified, assessed, mitigated, and monitored throughout the product lifecycle. •Attracts, develops, and retains top talent to build an outstanding quality / regulatory function. Implements the required interpersonal structures and operating mechanisms to maintain appropriate oversight of the compliance status of the business and achieve results. •Grows and develops a customer-focused culture of personal quality in all site functions through leading, educating, and motivating site personnel using industry-leading practices. Qualifications: •<10% regional and international travel is expected. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!