Senior Director Contact Lens Quality

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** Job Function:*
* Quality

** Job Sub*
* ** Function:*
* Multi-Family Quality

** Job Category:*
* People Leader

** All Job Posting Locations:*
* Jacksonville, Florida, United States of America

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* Job Description:

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* The Sr. Director Contact Lens Quality, is accountable for overall strategy, execution and oversight of quality management systems, and regulatory compliance for J&J Vision Care sites, to achieve sustained business results relative to regulatory outcomes and product quality. The role reports to the VP Quality and Compliance, J&J Vision.

This position leads the Product Quality Lifecycle for Johnson and Johnson Vision Care, for contact lenses, and consumer eye health representing an end-to-end approach to product quality from invention to retirement.

The function is responsible for new product design control and validation, product stewardship and product quality improvements. In this role, the incumbent is accountable for product quality improvements strategy for the life cycle of product.

The role is responsible for Supplier Quality and External Manufacturing Quality oversight and management for the VC business.

Assure compliance with the applicable regulations such as, but not limited to, FDA QMSR 21 CFR Parts 820; ISO 13485, FDA Combo Regulation 21 CFR Parts 4;
Current Good Manufacturing Practice (CGMP) regulation 21 CFR 210/211, and international regulatory requirements (Japanese MHLW, Brazilian ANVISA) for the company's products.

Acts as a strategic partner with business leaders in the development of the segment business strategy, compliance strategy, and effectively links the Quality objectives to the business strategy and results.

Accountable for business results as part of J&J Vision Care's extended SC Leadership team.

Functional accountability includes execution of Quality Management Systems, Q&C Metrics, CAPA management, Document Control, Change Control, Records Management, IT Quality Systems, Quality Planning, Risk Management and Training, as applicable for each J&J Vision Care site.

Direct accountability and scope include: 3 manufacturing sites and 2 major business segments
-Contact lenses and contact lens cleaning solution and eye drops.

Accountable for J&J Vision Care, Quality Operations budget, and strategic plan. Develops, reviews, approves, and manages the Quality business plans for all plants, along with the appropriate human resources utilization. Analyzes budgets and processes to maintain and enhance lean operations.

Work with JJ Vision sites and relevant units to ensure efficient, compliant execution of the Quality Management System. Provides oversight and leadership for site remediation plans as required.

Maintains, sustains, and continuously improves the Quality Management Systems and monitors the performance and health of those Quality Management Systems through metrics and analytics.

Assesses Manufacturing-related product quality issues and escalate to upper management as appropriate.

Ensure excellent internal customer satisfaction globally by addressing feedback, meeting needs, and supporting reliable, safe, high-quality products with full regulatory compliance.

Encourages compliance and effective risk management across the organization. Supports departmental and franchise goals while following the Johnson & Johnson Credo and local safety and environmental policies.

Develops…