Senior Manager Product Quality Management

Johnson & JohnsonIrvine, CA
Hybrid

About The Position

Johnson & Johnson Vision, a member of the Johnson & Johnson family of companies, is recruiting for a Senior Manager, Product Quality Management. This position leads the monitoring, analysis, and improvement of all aspects of brand quality from New Product Introduction (NPI) through to the customer. It also involves communicating brand health back to commercial teams to improve brand equity. In parallel, the role works with regulatory and quality systems at both operating company and enterprise levels to monitor the health authorities’ compliance landscape and proactively incorporate it into the improvement strategy. The position leads the strategic 10-year overview quality plan per brand, addressing patient needs through a combination of new product and improvement approaches.

Requirements

  • University / Bachelor’s Degree or Equivalent (required)
  • 8+ years working experience in Statistics/Process Engineering/Medical Device Industry (required)
  • Up to 10% domestic and international travel (required)

Nice To Haves

  • Bachelor’s Degree in Statistics/Engineering/Science (preferred)
  • Advanced degree Technical/MBA (preferred)
  • 3+ years experience in at least 2 of the 3 following domains: R&D, Manufacturing, Quality
  • Excellent communication, interpersonal and organizational skills.
  • Understanding and application of principles, concepts and practices of statistical methods (preferred)
  • Excellent technical understanding of manufacturing equipment and processes (preferred)
  • Understanding of the NPI process.
  • Demonstrated experience in technical improvements process. (Preferred)
  • Thorough understanding of GMP/ISO regulations, validation regulations.
  • Strong leadership, mentoring skills.
  • Demonstrated management abilities.
  • Demonstrated leadership ability over several functions.
  • Business sense and experience.
  • Able to build cost savings and growth business cases

Responsibilities

  • Act on the strategy by holding key quality decisions on the brands.
  • Partner with the commercial organization, regional offices, Regulatory, and Complaint handling to gather information on brand performance in the field.
  • For new products, partner with R&D leadership to modify new product development to optimize product quality. Assess new product launches related to product quality and have the scope to accelerate, modify, or delay them.
  • For existing products, partner with Supply Chain Leadership to assess and implement modifications to manufacturing processes and lead the strategy of manufacturing improvements related to product quality.
  • Lead the over-arching CAPAs (Corrective and Preventive Actions) on product quality topics.
  • Accountable for short-term brand decisions, reviewing and assessing any brand-wide deviation from design intent.
  • Co-own product decisions with the site quality leader in cases of deviations.
  • Hold signature authority on non-conformances and change control for assigned product lines.
  • Be accountable and signatory for quality plans, control plans, major changes, and validations.
  • Responsible for communicating to all levels of the organization and integrating the brand quality plan into the overall product value stream with specific and quantifiable business outcomes.
  • Adhere to environmental policy and procedures and support department environmental objectives.

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 period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
  • Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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