Senior Director Contact Lens Quality

Johnson & Johnson • Jacksonville, FL

4d • Onsite

About The Position

The Sr. Director Contact Lens Quality is accountable for the overall strategy, execution, and oversight of quality management systems and regulatory compliance for J&J Vision Care sites, aiming to achieve sustained business results relative to regulatory outcomes and product quality. This role reports to the VP Quality and Compliance, J&J Vision, and leads the Product Quality Lifecycle for Johnson and Johnson Vision Care's contact lenses and consumer eye health products, encompassing an end-to-end approach from invention to retirement. The function is responsible for new product design control and validation, product stewardship, and product quality improvements. The incumbent is accountable for the product quality improvements strategy throughout the product lifecycle and oversees Supplier Quality and External Manufacturing Quality for the Vision Care business. This role ensures compliance with applicable regulations such as 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). The position acts as a strategic partner with business leaders in developing segment business and compliance strategies, effectively linking Quality objectives to business strategy and results. The role is accountable for business results as part of J&J Vision Care's extended Supply Chain Leadership team. Functional accountability includes the 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. The role is accountable for the J&J Vision Care Quality Operations budget and strategic plan, developing, reviewing, approving, and managing Quality business plans for all plants, along with appropriate human resources utilization. It involves analyzing budgets and processes to maintain and enhance lean operations and working with J&J Vision sites and relevant units to ensure efficient, compliant execution of the Quality Management System. The position provides oversight and leadership for site remediation plans as required, maintains, sustains, and continuously improves the Quality Management Systems, and monitors their performance and health through metrics and analytics. It assesses manufacturing-related product quality issues and escalates them to upper management as appropriate, ensuring excellent internal customer satisfaction globally by addressing feedback, meeting needs, and supporting reliable, safe, high-quality products with full regulatory compliance. The role encourages compliance and effective risk management across the organization, supports departmental and franchise goals while adhering to the Johnson & Johnson Credo and local safety and environmental policies, and develops talent to ensure a steady supply of skilled quality and regulatory compliance experts for J&J Vision Care, J&J Vision, and the broader J&J organization.

Requirements

• Bachelor’s Degree – Scientific Discipline, Engineering, or equivalent related experience.
• >10 years of working experience in strategy and QMS execution in a highly regulated medical device global business.
• These >10 years must also include a minimum of 5 years’ experience in at least one of the following: manufacturing/quality operations, quality engineering, manufacturing engineering and/or R&D/New Product Development environment.
• A minimum of 7 years management experience.
• Strong communication, organizational, collaboration and interpersonal skills.
• Strong business acumen required.
• Proven track record of results and strong leadership capabilities.
• Comprehensive understanding of process and product improvement methodologies.
• Knowledge, understanding and application of quality and regulatory compliance principles, concepts and practices related to quality systems regulated by domestic and foreign governments.

Nice To Haves

• Six Sigma Black Belt certification is highly desirable, though not mandatory.

Responsibilities

• Responsible for all quality and compliance related activities in J&J Vision Care.
• Ensures the proactive identification of quality and compliance risks and the corresponding improvement plans.
• Strategic planning and execution as a member of J&J Vision Q&C leadership team.
• Manages capital and expense budgets for department.
• Formulates and implements annual department goals, action plans, and budgets according to Business unit priorities.
• Establishes strategy for quality and compliance across the J&J Vision Care manufacturing sites and ensures adequate resources to support global programs.
• Effectively partners with senior management to support audit readiness/preparation for risk mitigation and corrective and preventative actions and on-going process improvements.
• Works collaboratively with Operations, R&D, and Process Excellence to establish strategies aimed at ongoing customer-focused enhancements.
• Leads ongoing improvement initiatives within the segment, integrating risk management, process excellence, and measurement systems to ensure that business benefits are aligned with actions and resource prioritization.
• Ensures all products are manufactured to the highest safety and quality levels.
• Assures a risk management approach which achieves an acceptable risk-benefit balance to quality, compliance, and business objectives.
• Through risk management strategies, support the business unit in delivering results and fosters a culture change within the segment that embraces risk management tools and techniques.
• To recruit and further develop high caliber Quality and Compliance professionals.

Benefits

• Consolidated retirement plan (pension)
• Savings plan (401(k))
• Long-term incentive program
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year (varies by state)
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director