Head of Quality Systems & Compliance, ISC Quality
About The Position
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.
Requirements
- 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.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
Nice To Haves
- Relevant training, experience, and certification in Continuous Improvement practices, such as Lean/ Six Sigma, are highly preferred
Responsibilities
- 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.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
