Senior Director Contact Lens Quality

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Multi-Family Quality

Job Category:

People Leader

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

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 talent to ensure a steady supply of skilled quality and regulatory compliance experts for J&J Vision Care, JJ Vision, and the broader J&J organization.

Main areas of responsibility

• 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.

Education and Experience Required for Role

• Bachelor’s Degree – Scientific Discipline, Engineering, or equivalent related experience.

• Minimum experience (number of month /years and type of work experience beyond formal education) required for competent performance:

• >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. Experience to include 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; Six Sigma Black Belt certification is highly desirable, though not mandatory.

• Knowledge, understanding and application of quality and regulatory compliance principles, concepts and practices related to quality systems regulated by domestic and foreign governments.

                 

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Budget Management, Compliance Management, Corrective and Preventive Action (CAPA), Developing Others, Inclusive Leadership, Internal Auditing, ISO 9001, Leadership, Leading Change, Process Optimization, Quality Control (QC), Quality Processes, Quality Standards, Quality Validation, Resource Planning, Risk Management, Standard Operating Procedure (SOP), Tactical Planning

 

 

The anticipated base pay range for this position is :

$178,000.00 - $307,050.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits