Head of Quality Systems & Compliance, ISC Quality

Job Title

Head of Quality Systems & Compliance, ISC Quality

Head of Quality Systems & Compliance, ISC Quality

This leadership role is responsible for providing direction and execution regarding quality systems, compliance, and quality engineering services for the Integrated Supply Chain Quality Organization.

Your role:

• Drives the establishment and maintenance of the ISC quality management system, ensuring compliance with regulations and requirements globally where products are manufactured and marketed.
• Lead strategic regulatory compliance team supporting ISC sites, ensuring full compliance of system and execution with regulations and standards such as 21 CFR Part 820, ISO 13485, and ISO 9001 for product manufacturing. Includes driving consistent inspection readiness activities, supporting external inspections and strategic oversight of observation responses and actions.
• Lead Quality Engineering Center of Excellence, consisting of expertise and specialized skill sets related to production, process controls, and distribution. Driving ISC QA strategic initiatives such as acceptance activities, process monitoring, and nonconformance reductions to improve product quality, process effectiveness, and compliance.
• Drive integrated supply chain quality planning and strategy.
• Drive management responsibilities/reviews across the ISC manufacturing sites and regions, establishing KPIs and monitoring to ensure effectiveness of the Quality System and organization execution.
• Acts as a key influence and change agent on the cross-functional leadership teams to effectively improve quality and compliance outcomes for ISC.
• Lead, collaborate, and partner with site quality leaders, business unit quality, and global teams on strategic initiatives and transformations.
• Attract, develop, and retain a team of high-skilled, quality, and compliance experts. Deploy talent development and succession planning.

You're the right fit if:

• Bachelor's / Master's Degree in Engineering, Business Administration, Quality Management or equivalent.
• 11+ years of experience with Quality Management and Regulatory Compliance in the Medical Device/ Biotech industry or equivalent
• Must have leadership experience in various aspects of Quality (including internal and external representation on Quality) AND preferably in at least one operating process domain, preferably supply chain
• Must be experienced in establishing quality strategies, quality oversight and quality systems, preferably at the group/ corporate level in a large multinational company.
• Must be familiar with business process management framework, including industry practices such as APQC.
• Relevant training, experience, and certification in Continuous Improvement practices, such as Lean/ Six Sigma, are highly preferred
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

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 Plymouth, MN is $196,875 to $315,000

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

The pay range for this position in San Diego, CA 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…