Sr. Manager, Quality Assurance

Company Overview

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130‑year history of innovation and service to the dental industry and patients worldwide. The company develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world‑class brands. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, and its shares are listed on NASDAQ under the symbol XRAY.

Role Overview

Working at Dentsply Sirona provides opportunities to develop faster through professional development, perform better within a high‑performance culture, shape an industry as part of a market leader, and make a difference by improving oral health worldwide. The role leads Quality and Regulatory Compliance activities for the site, overseeing implementation, management, and sustainment of the site‑wide quality assurance program to ensure conformity with applicable regulatory requirements.

Responsibilities

• Lead applicable Quality and Regulatory Compliance activities for the site, ensuring conformity with US FDA, ISO 13485, MDD/MDR, CMDCAS, PMDA and other applicable quality and regulatory requirements.
• Oversee Regulatory Affairs for pharmaceutical products.
• Manage, coach, and develop Quality and Regulatory associates.
• Ensure the quality system is implemented at all levels to meet regulatory requirements (FDA QSR, cGMP, ISO 13485, CMDCAS, European MDD/MDR, ANVISA, PMDA, Australian TGA).
• Determine areas of regulatory risk to an acceptable value.
• Serve as the Person Responsible for Regulatory Compliance at the Dentsply LLC site per EU Regulation 2017/745.
• Act as official FDA correspondent, handling device registration, product listing, communications, updates, and submissions via the FDA’s FURLS system.
• Serve as Management Representative per ISO 13845:2016 and Responsible Engineering Manager for the Smile Way site under Japan’s PMD Act.
• Manage and coordinate site external audits (FDA, Notified Bodies, Corporate), including audit findings response, corrective actions, and follow‑up.
• Develop and implement systems to measure and increase quality across all areas to assure regulatory compliance.
• Manage Quality review and approval of product labeling, PCOs, marketing advertising, and promotional literature.
• Support and develop LEAN and Change Management activities to reduce administration, improve QMS performance, and generate additional value.
• Ensure all related quality and regulatory documentation is appropriately managed and maintained according to established procedures.
• Oversee the internal audit program, ensuring thorough audits, timely CAPA root‑cause identification, and corrective actions.
• Oversee management and deployment of corporate/product‑group software applications/workflows to standardize requirements.
• Implement appropriate controls to ensure site‑level records are maintained/archived to meet record‑retention requirements.
• Implement and maintain the Site Supplier Quality Management system, maintain an approved supplier list, and monitor supplier performance.
• Manage product and process change‑control system, ensuring adequate approvals and implementation of changes.
• Ensure compliance with complaint‑management requirements (e.g., Trackwise), including review for reportability, generation of MDR opinions, ASR reports, investigation, trending, market‑action assessment, CAPA initiation, and pharmacovigilance activities.
• Oversee the site Management Review process, including data collection, presentation preparation, and scheduling.
• Manage the overall site CAPA and Nonconformance system, ensuring investigations, root‑cause analysis, action planning, verification, and effectiveness.
• Establish and manage Quality metrics to determine the need for CAPAs.
• Manage site Quality associates to support the Product Group design‑control team, providing subject‑matter expertise for quality and regulatory requirements.
• Ensure appropriate review of design‑control documents for compliance (design input, output, verification, validation, labeling claims, design transfer).
• Oversee and review Technical File documents for CE marking.
• Manage preparation of documents for regulatory submissions in the US, including 510(k)s.
• Submit applicable information to Corporate for site registration, device listings, and Canadian registrations.
• Manage support functions for international registrations, including document, labeling, and record submissions in collaboration with R&D, Operations, Clinical, and Marketing.
• For pharmaceutical products: ensure timely delivery of high‑quality CTD documents for regulatory approvals, including comprehensive CMC content, and provide data for registration to other countries.

Key Leadership Behaviors

• Ability to drive cross‑functional teams at senior levels and across regions.
• Creative and inquisitive mindset.
• Strong relationship‑building skills.
• High level of personal accountability.
• Conflict‑resolution skills in complex management organizations.
• Culturally sensitive.
• Strong sense of team and fair play.
• Demonstrates People Manager competencies: Talent Management, Leading Change, Strategic Thinking, Drive for Results, Customer Focus, Teamwork, Integrity, Problem Solving, Accountability, Innovation and Creativity.

Background Requirements

Education: Bachelor’s degree or equivalent in science or engineering.

Certifications/Licensing: