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SVP, Global Quality
3 months ago
Location: Austin, Texas; Fort Worth, Texas, Cranberry Twp, PA
The Senior Vice President (SVP) of Global Quality and Regulatory is responsible for developing and executing the company's quality strategy, ensuring all products and services achieve the highest standards of quality and compliance. A core aspect of this role is to champion "Quality First" as a strategic priority. This position leads the Quality Department, drives continuous improvement initiatives, fosters a culture of quality throughout the organization, and collaborates with cross-functional teams to integrate quality into every aspect of the business.
The SVP oversees quality compliance through the product lifecycle including design and development, production quality, product quality, installation, and service, including managing quality from key contract manufacturers and suppliers.
As the designated Management Representative and primary corporate interface with the FDA and international regulatory authorities, the SVP builds and maintains excellent relationships with health authorities and corporate partners, effectively advocating the company's position.
This highly visible role involves significant interaction with Engineering, Product, Product Operations, Manufacturing, Field Operations, and Senior Executives. The SVP also directly interacts with customers, overseeing the product escalation process to ensure prompt resolution of customer issues.
Key Responsibilities:
Leadership and Strategy: Develop and execute global quality and regulatory strategies. Lead and mentor a high-performing team. Create a cohesive, agile and data driven quality ecosystem. Quality Management: Assess and propose strategies for a contemporary Enterprise Quality Management System (EQMS) that integrates advanced technology, enterprise-wide quality management solutions and holistic end-to-end processes Regulatory Affairs: Implement global regulatory strategies for timely product registrations and approvals. Ensure compliance with FDA, EU Medical Device Directives, ISO 13485, and all product specific industry standards and regulations. Product Conformance: Oversee product conformance to 21 CFR 820 for Class I and II medical products. Cross-Functional Collaboration: Work with Engineering, Product, Manufacturing, Marketing, and others to drive quality culture and regulatory requirements. Risk Management and Compliance: Implement a risk management framework across all processes, allowing proactive identification, assessment and mitigation of risk. Supplier Quality Management: Real-time collaboration with suppliers through the EQMS ensuring consistent quality of incoming materials and components and enabling rapid response to any quality deviations. Training and Competency Management: Implement and manage a robust training management system ensuring all employees are equipped with the necessary skills and knowledge to perform their roles effectively from a quality perspective.Elevate Behaviors:
Collaborate: Build networks and resolve conflicts. Inspire: Speak up, influence others, and support team efforts. Develop: Pursue continuous learning and provide candid feedback. Execute: Plan effectively, manage timelines, and demonstrate accountability. Impact: Solve problems, innovate, and adapt to changes.Qualifications:
Bachelor’s degree in a relevant field (., Life Sciences, Engineering, Quality Management); advanced degree preferred. Minimum of 15 years of experience in quality management roles within the healthcare, pharmaceutical, medical device, or manufacturing industries. Proven track record of successful leadership and management in quality function. Minimum of 10 years of FDA Medical Device experience – 21 CFR 820, 806 and 803. Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization. International management and managing remote employees at domestic and international sites. Ability to work cross-functionally and develop strong relationships with Engineering, Product, Operations and Service and solving cross-functional issues both strategically and tactically in a manner that builds, maintains, and enhances positive working relationships. Successful implementation and management of a Enterprise Quality Management System utilizing contemporary software, data driven insights, digital workflows and automated compliance reporting.Preferred Knowledge and Skills:
Engineering or related degree preferred. Masters degree is desired but not required.Work Conditions:
Office conditions. Travel: 12+ trips annually to suppliers, customers, and various Omnicell locations (domestic and international).Location Requirement:
This role requires the candidate to be located near one of our offices or to be willing to relocate to one of the following locations: Cranberry Township, PA, Austin, TX, or Fort Worth, TX. Please ensure that your current or future location aligns with this requirement before applying.
