Head of Quality, Clinical Informatics

Job Title

Job Description

Head of Quality, Clinical Informatics

Enterprise Informatics is on a mission to grow, and we do this by transforming our portfolio to be fully cloud-based, so we can help our customers optimize workflows and care with insights through AI. You will become the Quality Leader for the Clinical Informatics Business Unit, which aims to scale cloud-first, AI-enabled innovations and drive profitable growth across multiple high-priority care settings. The Clinical Informatics Business Unit spans a total of five different Business Categories with different portfolios across Acute Care, Advanced Visualization & Insights, Digital Pathology, Urology, and Electronic Medical Records.

The Quality Leader for CI is responsible for managing a global Quality organization, which is organized in line with the CI Business Categories. The Quality Leader is responsible for leading quality vision and strategy for a specific business area, and for being the driving force in making the organization an industry-leading organization through proactive quality compliance and proactive quality excellence, ensuring a culture of quality is embedded throughout the organization. The role oversees quality management, leads the overall plan for regulatory submissions for product/solution compliance, enforces a robust regulatory process, and harmonizes them across functions. The role provides strategic direction to senior managers in various areas, identifies opportunities for improvement and innovation in quality processes, and ensures compliance with applicable regulations such as FDA, EU-MDR regulations, and other Regulatory Requirements

Your role:

• Lead the CI Quality organization in improving and innovating quality processes, systems, and practices leveraging AI. Enable as part of this role the shift to a SaaS operating model within the Quality team to support the Business in the delivery roadmaps.
• Leads development and execution of global quality vision and strategy for a specific business area through initiation and coordination of related activities throughout all disciplines, ensuring alignment with business objectives, compliance and regulatory requirements.
• Oversee quality management, safety, and compliance, authorize their implementation, and ensure adherence across all business units and operations.
• Leads the overall plan for regulatory submissions for product/solution compliance, ensures compliance with applicable regulations such as FDA, EU-MDR regulations, and other Regulatory Requirements such as ISO13485, 21 CFR 820, and ensures guidelines for all products and operations are consistent with those regulations.
• Creates regulatory awareness level as determined within the organization, enforces robust regulatory processes, and harmonizes them across functions, establishing an effective management review process, including routine reporting on regulatory compliance activities.
• Leading the Quality team after the recent organizational changes to create an engaged team working closely together across the different parts of the Business. Lead succession planning and comprehensive talent management, driving employee selection, performance management, compensation management, and career development in alignment with organizational operational goals.
• Possesses leadership experience in at least one operating process domain (product development, supply chain, or others) and various aspects of quality, demonstrates familiarity with business process management framework and regulatory strategy development and quality system oversight at group/corporate level in a large multinational company.
• Identifies and evaluates fundamental issues, possesses in-depth knowledge of functional area, business strategies, and company goals, interacts internally and externally with executive-level management, controls activities of one or more functional areas, and drives planning, staffing, budgeting, managing expense priorities, and proposing methodological changes.

You're the right fit if:

• Bachelor's / Master's Degree in Engineering, Business Administration, Quality Management or equivalent
• 11+ years of experience in areas such as Quality Management, Regulatory Compliance in the Medical Device/ Biotech industry or equivalent
• Possesses leadership experience in at least one operating process domain (product development, supply chain, or others) and various aspects of quality, demonstrates familiarity with business process management framework and regulatory strategy development and quality system oversight at group/corporate level in a large multinational company.
• 7+ years of People Leadership experience
• Able to adapt quickly in a continuously changing / dynamic environment
• Strong business acumen, preferably in an informatics environment and proven experience in adopting AI in ways of working and processes
• Strong experience in CAPA Methodologies
• Experienced in working in an organization with multiple Quality Management Systems

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in Gainesville, FL is $187,500 to $300,000

The pay range for this position in Cambridge, MA is $210,000 to $336,000

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.    

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.  Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.  Details about our benefits can be found here. 

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.