Johnson & Johnson
Senior Manager, Product Quality Management
Johnson & Johnson, Irvine, California, United States, 92713
Johnson & Johnson Vision, a member of the Johnson & Johnson family of companies, is recruiting for a Senior Manager, Product Quality Management! This position can be located in Milpitas, CA or Irvine, CA.
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.
Through partnership with Supply Chain (Ops, Value stream), R&D, QA, and commercial leadership, this position leads the monitoring, analysis and improvement of all aspects of brand quality from NPI through to the customer as well as the communication back to commercial on the brand health, to improve brand equity. In parallel to the field performance, work with regulatory and quality systems both at an operating company level and an enterprise level, to look at the health authorities’ compliance landscape and incorporate proactively in the improvement strategy.
As a result, the position leads the strategic 10-year overview quality plan per brand addressing patient needs, using a combination of new product and improvement approaches.
Key Responsibilities:
Partner with commercial organization, regional offices, Regulatory and Complaint handling to gather all short and long term information on the brands as they relate to performance in the field.
For new products, partner with R&D leadership to modify the new product development to optimize product quality. Position has the accountability assess these launches as they relate to Product quality and has the scope to accelerate, modify or delay new product launches.
For existing products, partner with Supply Chain Leadership to assess and implement modifications to the manufacturing processes and lead the strategy of manufacturing improvements as they relate to product quality.
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.
This position is measured by the brand scorecard health which includes internal Quality metrics (NCs, Quality events), external Quality metrics (such as Customer complaints), Supply chain metrics (such as COGS) and Commercial metrics (such as adherence to BP).
Adheres to environmental policy and procedures and supports department environmental objectives.
Qualifications:
Education:
A minimum of Bachelor’s or equivalent University degree is required, with a focus in Statistics, Engineering & Science preferred. Masters or advanced degree preferred.
Required:
8+ years working experience in Statistics/Process Engineering/Medical Device Industry (required).
Excellent communication, interpersonal and organizational skills.
Understanding of the NPI process.
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.
Preferred:
3+ years experience in at least 2 of the 3 following domains: R&D, Manufacturing.
Excellent technical understanding of manufacturing equipment and processes.
Demonstrated experience in technical improvements process.
Understanding and application of principles, concepts and practices of statistical methods.
Other:
This position may require up to 20% domestic & international travel.
The anticipated base pay range for this position is 118000 to 203550. California Bay Area - The anticipated base pay range for this position is 136000 to 234140.
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 on the basis of disability.
#J-18808-Ljbffr
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.
Through partnership with Supply Chain (Ops, Value stream), R&D, QA, and commercial leadership, this position leads the monitoring, analysis and improvement of all aspects of brand quality from NPI through to the customer as well as the communication back to commercial on the brand health, to improve brand equity. In parallel to the field performance, work with regulatory and quality systems both at an operating company level and an enterprise level, to look at the health authorities’ compliance landscape and incorporate proactively in the improvement strategy.
As a result, the position leads the strategic 10-year overview quality plan per brand addressing patient needs, using a combination of new product and improvement approaches.
Key Responsibilities:
Partner with commercial organization, regional offices, Regulatory and Complaint handling to gather all short and long term information on the brands as they relate to performance in the field.
For new products, partner with R&D leadership to modify the new product development to optimize product quality. Position has the accountability assess these launches as they relate to Product quality and has the scope to accelerate, modify or delay new product launches.
For existing products, partner with Supply Chain Leadership to assess and implement modifications to the manufacturing processes and lead the strategy of manufacturing improvements as they relate to product quality.
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.
This position is measured by the brand scorecard health which includes internal Quality metrics (NCs, Quality events), external Quality metrics (such as Customer complaints), Supply chain metrics (such as COGS) and Commercial metrics (such as adherence to BP).
Adheres to environmental policy and procedures and supports department environmental objectives.
Qualifications:
Education:
A minimum of Bachelor’s or equivalent University degree is required, with a focus in Statistics, Engineering & Science preferred. Masters or advanced degree preferred.
Required:
8+ years working experience in Statistics/Process Engineering/Medical Device Industry (required).
Excellent communication, interpersonal and organizational skills.
Understanding of the NPI process.
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.
Preferred:
3+ years experience in at least 2 of the 3 following domains: R&D, Manufacturing.
Excellent technical understanding of manufacturing equipment and processes.
Demonstrated experience in technical improvements process.
Understanding and application of principles, concepts and practices of statistical methods.
Other:
This position may require up to 20% domestic & international travel.
The anticipated base pay range for this position is 118000 to 203550. California Bay Area - The anticipated base pay range for this position is 136000 to 234140.
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 on the basis of disability.
#J-18808-Ljbffr