Johnson & Johnson Careers

SR. DIRECTOR, QUALITY OPERATIONS - SURGICAL VISION

Santa Ana, California; Jacksonville, Florida; Limerick, Ireland
Quality (Generalist)


Job Description

Requisition ID: 5558190523

The Sr. Director, Quality Operations, Surgical Vision is accountable for overall strategy, execution and oversight of quality management systems, and regulatory compliance for J&J Surgical Vision sites, to achieve sustained business results relative to regulatory outcomes and product quality. This position reports to the VP Quality and Compliance, J&J Vision and is located in Santa Ana, CA.  Either Jacksonville, Florida, or Limerick, Ireland may be considered as other locales.

  • Assures compliance with the applicable regulations such as, but not limited to, FDA Quality system Regulation 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.
  • Directly accountable for business results within J&J Surgical Vision.
  • Manages quality, safety, and compliance escalation process within J&J Surgical Vision.
  • 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 Surgical Vision site.
  • Direct accountability and scope includes: 4 manufacturing sites and 2 major business segments –Interocular Lenses and Cataract surgery equipment.
  • Accountable for J&J Surgical Vision, 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.
  • Partners with JJ Vision sites and related organizational units (e.g., Quality Systems and Lifecycle Management) to ensure that Quality Management System execution is compliant, effective, and efficient. 
  • Oversees and leads site remediation plans, as necessary and as needed.
  • 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. 
  • Assures the highest levels of internal customer satisfaction around the world, responding to internal customer feedback, supporting internal customer needs and help to ensure reliable, safe and effective, high-quality, end-to-end product supply and outstanding regulatory compliance performance.
  • Promotes a culture of compliance to regulations, standards, and procedures and risk management throughout the organization.  Supports departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
  • Ensures talent development processes are implemented and executed to maintain a healthy pipeline of quality & regulatory compliance talent for J&J Vision Care and overall JJ Vision and as part of the larger J&J Quality & Regulatory Compliance talent process.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

  • Full, direct supervisory responsibilities of Quality Operations including quality and compliance for Supply Chain related activities in J&J Surgical Vision.
  • 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.
  • Directly accountable for business results within J&J Surgical Vision.
  • Establishes strategy for quality and compliance across the J&J Surgical Vision 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.
  • Partners with Operations, R&D and Process Excellence to set strategies that drive continuous improvements for the customer. Champions continuous improvement initiatives across the segment that incorporates risk management, process excellence and measurement systems to align business benefits with action 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, supports the franchise in delivering business results and fosters a culture change within the segment that embraces risk management tools and techniques.
  • Recruits and further develops high caliber Quality and Compliance professionals.


Qualifications
  • Bachelor’s degree in scientific discipline, engineering or equivalent related experience is required.
  • Minimum 10 to 12 years of working experience in strategy and QMS execution in a highly regulated medical device global business. These 10 to 12 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.
  • Strong knowledge of process and product improvement methodologies (Six Sigma Black Belt certification is highly desirable but not required).
  • Knowledge, understanding and application of quality and regulatory compliance principles, concepts and practices related to quality systems regulated by domestic and foreign governments.
  • Understanding and working knowledge of a broad set of regulations and standards such as, but not limited to, FDA Quality system Regulation 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 Bachelor’s degree in scientific discipline, engineering or equivalent related experience, Brazilian ANVISA).
 

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against based on disability. 



Primary Location
United States-California-Santa Ana-1700 E Saint Andrew Place
Other Locations
North America-United States-Florida-Jacksonville, Europe/Middle East/Africa-Ireland-Limerick-Limerick
Organization
Johnson & Johnson Vision Care, Inc. (6094)
Job Function
Quality (Generalist)
Requisition ID
5558190523