Head of Quality Assurance

17 hours ago


Carlsbad, United States Novartis Group Companies Full time

Job Summary

This is a senior leadership role responsible for leading the Quality team and ensuring compliance with regulatory requirements. The successful candidate will have a strong background in quality assurance, regulatory compliance, and leadership.

Key Responsibilities

  • Lead the Quality team to ensure compliance with regulatory requirements
  • Develop and implement quality metrics and systems
  • Conduct GxP, CLIA, and IVD manufacturing training
  • Manage staff to ensure timely delivery of responsibilities
  • Provide quality assessment for assay/product validations
  • Establish and maintain Quality Systems to meet regulatory requirements
  • Oversee regulatory, sponsor, and external vendor audits
  • Identify opportunities for improvement and implement changes
  • Develop metrics, reports, and documentation for Quality Management Review

Requirements

  • Minimum of 12 years of experience in a related Quality Assurance role
  • Minimum of 7 years of experience with clinical trials supporting GCLP
  • Minimum of 5 years of leadership and direct supervisory experience
  • CLS license desired
  • IVD experience desired

Skills

  • Detail-oriented with ability to manage multiple projects
  • People leadership across all areas of Quality
  • Strong agility, collaboration, and teamwork
  • Clear understanding of Clinical Labs in support of drug development clinical trials
  • Strong experience in managing and hosting Sponsor and Regulatory audits
  • Decision-making skills with understanding of risk, operational practices, and compliance

Languages

  • English

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [insert email address].

Salary Range

$192,000.00 - $288,000.00

Skills Desired

Auditing, Auditing, Audits Compliance, Business Partnerships, Business Strategies, Commercial Acumen, Communication, Continuous Learning, Decision Making, Employee Performance Evaluations, Financial Acumen, GMP Procedures, Goal-Oriented, Group Problem Solving, Health Authorities, Leadership, Logical Thinking, Major Incident Management, Managing Ambiguity, People Management, QA (Quality Assurance), Self-Awareness, Smart Risk Taking, Speed and Agility Training, Stakeholder Management

  • Carlsbad, United States Novartis Group Companies Full time

    Job DescriptionNovartis Group Companies is seeking a highly skilled and experienced Head of Quality Assurance to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality in all aspects of our business.Key Responsibilities:Develop and implement quality management systems to ensure compliance...


  • Carlsbad, United States Novartis Group Companies Full time

    Job DescriptionThis position is responsible for leading the Quality team in ensuring compliant processes, team management, and oversight of Quality compliance and operations in support of EU, FDA, Clinical Trial, CLIA/CAP, state, and ISO compliance requirements.Key ResponsibilitiesManage personnel and compliance for assay validation, clinical study...


  • Carlsbad, United States Novartis Group Companies Full time

    Job Description SummaryThis position is responsible for leading the Quality team, ensuring compliant processes, team management, and oversight of Quality compliance and operations in support of EU, FDA, Clinical Trial, CLIA/CAP, state, and ISO compliance requirements.Key ResponsibilitiesManage personnel and compliance for assay validation, clinical study...


  • Carlsbad, New Mexico, United States Salado Isolation Mining Contractors Full time

    Quality Assurance Analyst Job DescriptionWe are seeking a highly skilled Quality Assurance Analyst to join our team at Salado Isolation Mining Contractors. As a Quality Assurance Analyst, you will play a critical role in ensuring the quality of our operations and maintaining compliance with regulatory requirements.Key Responsibilities:Develop and implement...


  • Carlsbad, New Mexico, United States Salado Isolation Mining Contractors Full time

    Job Title: Quality Assurance AnalystWe are seeking a highly skilled Quality Assurance Analyst to join our team at Salado Isolation Mining Contractors. As a key member of our organization, you will be responsible for ensuring the quality and integrity of our operations.Key Responsibilities:Develop and implement quality assurance plans and procedures to ensure...


  • Carlsbad, United States Omni Inclusive Full time

    Job Title: Quality Assurance SpecialistOmni Inclusive is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes.Responsibilities:Assist with periodic product audits and inspections to ensure compliance with AS9100...


  • Carlsbad, New Mexico, United States Chili's Grill & Bar Full time

    Quality Assurance SpecialistAt Chili's Grill & Bar, we're looking for a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring that every guest receives perfectly prepared, high-quality food. Your attention to detail and commitment to excellence will make a real difference in our...


  • Carlsbad, United States Jon Renau Collection Inc. TS Full time

    Job DescriptionJob DescriptionQuality Assurance Manager at Jon Renau Collection Inc. TSWe are seeking a highly skilled Quality Assurance Manager to join our team at Jon Renau Collection Inc. TS. As a Quality Assurance Manager, you will play a critical role in ensuring the quality of our products and services, while collaborating with cross-functional teams...


  • Carlsbad, United States Danaher Corporation Full time

    About the RoleWe are seeking a highly skilled and motivated Quality Assurance Engineer to join our team at Beckman Coulter Diagnostics. As an Associate Technician Quality Assurance, you will play a critical role in ensuring the quality and reliability of our clinical analyzers.Key ResponsibilitiesPerform full range of Instrument PM and quality control tests...


  • Carlsbad, United States CCS Corp Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at CCS Corp. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, and maintaining compliance with regulatory requirements.Key Responsibilities:• Conduct incoming inspections of raw materials and packaging...


  • Carlsbad, California, United States IMS People Full time

    Job OverviewWe are seeking a highly skilled Quality Control Technician to join our team at IMS People. The successful candidate will be responsible for ensuring the quality of our products and processes, and will work closely with our Quality Assurance team to identify and resolve any quality issues.Key ResponsibilitiesConduct regular product audits and...


  • Carlsbad, United States SOLVD Health Full time

    Job SummarySOLVD Health is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our products.Key ResponsibilitiesMaintain quality control stock of materials and suppliesFollow strict quality control procedures to ensure compliance with...


  • Carlsbad, United States Omni Inclusive Full time

    Job SummaryWe are seeking a highly skilled Quality Technician to join our team at Omni Inclusive. As a Quality Technician, you will play a critical role in ensuring the quality of our products and processes.Key ResponsibilitiesAssist in conducting periodic product audits and inspections to ensure compliance with AS9100 standards.Investigate and resolve...


  • Carlsbad, United States CCS Corp Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at CCS Corp. The successful candidate will be responsible for ensuring the quality and compliance of our products and processes.Key Responsibilities:Perform line clearance, product packing documentation verification and review, and final label review.Conduct incoming...


  • Carlsbad, California, United States Kelly Services Full time

    Job OverviewWe're seeking a skilled Quality Technician to join our team at a premier company in Carlsbad, CA. This opportunity offers a chance to work with a leading organization and contribute to the success of their quality assurance initiatives.Key ResponsibilitiesAssist with product audits and inspections based on AS9100 Standard to ensure quality...


  • Carlsbad, United States SCIEX Full time

    Job Title: Senior Manager, Quality AssuranceSCIEX, a leading provider of mass spectrometry and capillary electrophoresis solutions, is seeking a highly experienced Senior Manager of Quality Assurance to join our team. As a key member of our Quality Assurance & Regulatory Affairs (QARA) team, you will be responsible for developing and implementing quality...


  • Carlsbad, New Mexico, United States Precision NDT LLC Full time

    Job DescriptionAt Precision NDT LLC, we are seeking a skilled Quality Assurance Inspector to ensure that our projects are implemented correctly. The successful candidate will be responsible for monitoring and verifying that our processes are followed and operative.Key Responsibilities:Verify that project approaches, techniques, methods, and processes are...


  • Carlsbad, United States ClearPoint Neuro, Inc. Full time

    About the JobWe are seeking a highly organized and detail-oriented Quality Engineer to support our quality management system and regulatory requirements at our Carlsbad, CA facility.The ideal candidate will have experience in the medical device field and a solid understanding of design controls and regulatory requirements.Company DescriptionClearPoint Neuro...


  • Carlsbad, California, United States OmniInclusive Full time

    Quality Technician IOmniInclusive is seeking a highly detail-oriented Quality Technician I to join our team. As a Quality Technician I, you will play a critical role in ensuring the quality of our processes and products.Key Responsibilities:Conduct audits and inspections to ensure compliance with AS9100 Standard and other quality standards.Investigate and...


  • Carlsbad, California, United States OmniInclusive Full time

    Quality Technician IOmniInclusive is seeking a highly detail-oriented Quality Technician I to join our team. As a Quality Technician I, you will play a critical role in ensuring the quality of our processes and products.Key Responsibilities:Conduct audits and inspections to ensure compliance with AS9100 Standard and other quality standards.Investigate and...