Senior Director Contact Lens Quality

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 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 companys 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 Cares 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

• Bachelors 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 () 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 :

$178000.00 - $307050.00

Additional Description for Pay Transparency:

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

This position is eligible to participate in the Companys 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: - Experience:

Exec