Sr. Manager, Quality Assurance

Lead applicable Quality and Regulatory Compliance activities for the Site, including the implementation, management, and sustainment of the Site-wide quality assurance program to ensure conformity with US FDA, ISO 13485, MDD/MDR, CMDCAS, PMDA and other applicable quality and regulatory requirements, including Product Group and corporate requirements. Oversee the Regulatory Affairs for pharmaceutical products.

Key Responsibilities:

• Responsible for managing, coaching, and developing Quality and Regulatory associates in aspects of applicable requirements and practices.
• Ensure that the quality system is implemented at all levels within the organizations to meet applicable regulatory requirements, including but not limited to FDA QSR, cGMP (Drugs), ISO 13485, CMDCAS, European MDD/MDR, ANVISA, PMDA and Australian TGA requirements. Determine areas of regulatory risk to an acceptable value.
• Serve as the Person Responsible for Regulatory Compliance at the Dentsply LLC site as per European Regulation (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, chapter I, article 15.
• The site Quality lead acts also as official correspondent for FDA and is responsible for being the main contact for the company’s device registration and product listing with FDA, managing all related communications, updates, and submissions through the FDA’s FURLS system.
• The Quality Assurance Director is designated as the Management Representative as per ISO13845:2016 and Responsible Engineering Manager (REM) for the Smile Way site, in accordance with Japan’s PMD Act.
• Management and coordination of site external audits including FDA, Notified Bodies, Corporate, etc., including audit findings response, corrective actions and follow-up.
• Develop and implement systems to measure and increase quality in all areas to assure regulatory compliance.
• Manages the Quality review and approval of product labeling PCOs, as well as Marketing advertising and promotional literature to ensure that labeling meets all applicable regulatory requirements.
• Support and develop LEAN and Change Management Activities to reduce administration, improve performance of the QMS and generate additional value for the site and Product Group.
• Ensure all related quality and regulatory documentation, including external standards, are appropriately managed and maintained according to established procedures.
• Responsible for the oversight of the internal audit program to meet requirements, including ensuring that all audits are thorough and conducted in accordance to the established internal audit schedule, while ensuring that all audit findings (observations, CAPAs) have appropriate Root Cause(s) identified and Corrective Actions completed on a timely basis.
• Oversee the management and deployment of Corporate/Product Group software applications/workflows to standardize requirements.
• Manage implementation of appropriate controls to ensure site level records are maintained/archived to meet applicable record retention requirements. 
• Manage the implementation and maintenance of Site Supplier Quality Management system, including maintaining a current approved supplier list at site level and monitoring performance of suppliers.
• Manage product and process change control system to ensure all changes are reviewed to ensure adequate approvals at site level (as applicable) and implemented in accordance with change plans.
• Ensures compliance with all applicable complaint management requirements to ensure that all complaints are appropriately documented (e.g. Trackwise), reviewed for reportability in the US, Canada, and EU in a timely manner, MDR opinions are generated for applicable complaints, ASR reports are generated as required, appropriately investigated, trended and reviewed, Market Actions are appropriately assessed (HHE), initiation of applicable CAPAs, and Pharmacovigilance Related Activities.
• Responsible for the oversite of the site Management Review process, including data collection, presentation preparation and timely scheduling.
• Manage the overall site CAPA and Nonconformance system to ensure that issues are appropriately investigated, root causes identified, appropriate actions items planned to address the root causes and that the root causes are verified and effective.
• Established and manages Quality metrics to determine the need for CAPA’s.
• Manage site Quality associates to support the Product Group design control team, including subject matter expertise for quality and regulatory requirements.
• Ensures the appropriate review of design control documents for compliance with internal and external requirements, including design input, design output, design verification, design validation, labeling claims and design transfer deliverables.
• Oversees and reviews Technical File documents for CE marking.
• Manage the preparation of documents for regulatory submissions in the US, including 510(k)’s.  Submit applicable information to Corporate for site registration and device listings, and Canadian registrations.
• Manage the support functions for international registrations, including document, labeling and record submissions (with other functions e.g., R&D, Operations, Clinical, Marketing).
• For Pharmaceutical Products: Ensures timely delivery of high-quality CTD documents for successful regulatory approvals, including comprehensive CMC content. 
• Provide data for registration to other countries.

Key Leadership Behaviors:

• Able to drive cross functional teams at senior levels and across regions
• Creative, inquisitive
• Strong relationship building skills
• High level of personal accountability
• Conflict resolution skills in complex management organization
• Culturally sensitive
• Strong sense of team and fair play

Dentsply Sirona leaders are expected to successfully demonstrate behaviors aligned with the People Manager Competency model.  Those competencies include:

• 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:

Six sigma certification would be preferred.

Years and Type of Experience:  5 plus years in a leadership role in quality/regulatory in life sciences, preferably in medical devices

Key Required Skills, Knowledge and Capabilities:

• Ability to work effectively through influence and relationships
• Proficient in Microsoft Office based systems, demonstrated ability to utilize data for presentation of thought and decision making
• Comprehensive understanding of lean principles and experience implementing in an operational environment
• Business acumen skills to effectively analyze data and trends.
• Ability to effectively motivate, train, coach, mentor and provide leadership to direct reports
• Excellent oral and written communication skills
• Strong organizational skillset with orientation towards detailed work
• Customer focused orientation with internal and external customers
• Ability to travel up to 10%
• Ability to effectively prepare and manage annual site department budget
• Ability to develop sound business cases to justify CapEx investments for site

The base salary and variable compensation for this role is between $166,750 and $195,500. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.