Lead GxP Compliance Auditor

1 week ago

Las Vegas, Nevada, United States Verista Full time
Job Overview

Verista is a leader in providing expert solutions to the life sciences sector, collaborating with prominent brands to address their operational needs. Our mission is to foster growth and innovation within the scientific community, assisting researchers and organizations in tackling significant healthcare challenges. At Verista, we pride ourselves on delivering cutting-edge services that facilitate informed decision-making, a testament to our commitment to investing in our people and capabilities.

Our growth is propelled by exceptional individuals who excel in collaborative environments and share our vision of enhancing the lives of our life sciences clients. Our dedicated professionals strive to make a meaningful impact daily.

Core Values and Company Culture:

  • We empower and uplift our colleagues.
  • We prioritize client success at every opportunity.
  • We possess the courage to uphold ethical standards.
  • We promote an inclusive atmosphere where every team member feels valued, engaged, and challenged.
  • We continuously seek to acquire new skills and learn from our experiences to enhance our collective expertise.

Key Responsibilities of the Principal Quality/GxP Auditor:

  • Formulate and present compliance strategies tailored to client specifications.
  • Provide expert consultation on industry best practices and regulatory standards.
  • Mentor and train junior team members to enhance their skills.
  • Assist in preparation for inspection readiness audits and large-scale remediation initiatives.
  • Serve as a subject matter expert in Quality & Compliance.
  • Guide clients in adhering to industry best practices and regulatory requirements.
  • Evaluate GxP auditing projects for accuracy, consistency, and quality, identifying areas for improvement.
  • Offer coaching and training to peers on quality-related topics and audit execution.
  • Exhibit business maturity and interpersonal skills for effective communication and collaboration.
  • Demonstrate the ability to articulate requirements clearly to various levels within the client's organization.
  • Foster the development of less experienced team members through mentorship.
  • Communicate effectively with clients to ensure clarity and understanding.
  • Identify potential areas for business growth and report findings to management.
  • Utilize intermediate skills in Microsoft Project.

Qualifications:

  • Willingness to travel to multiple client sites as needed.
  • Proven track record in delivering Quality Lead level outcomes.
  • Expertise in GxP regulatory standards and industry best practices.
  • Experience in delivering industry lectures and training based on practical experiences.
  • Ability to identify, propose, and market services to clients.
  • Minimum of 10 years of relevant experience in:
    • FDA regulations, particularly section 503B of the FD&C Act.
    • Current Good Manufacturing Practices - Title 21 CFR Parts 210, 211, 820.
    • Conducting Current State GAP Assessments and FMEA activities.
    • Developing and implementing risk-based CAPA Plans and remediation strategies.
    • Direct communication with Health Authorities.
  • Thorough understanding of Quality system principles, including FDA Quality System Regulations (cGMP), ISO 13485 for medical devices, and ISO 9001 Quality Management Systems.
  • Strong problem-solving and critical thinking abilities.
  • Excellent organizational and time management skills.
  • Meticulous attention to detail.
  • Intermediate proficiency in WORD for authoring and editing technical documents.
  • Basic skills in EXCEL and PowerPoint.
  • Strong interpersonal skills and effective communication capabilities.
  • Experience in adapting to high levels of challenge and change.
  • Ability to work independently and collaboratively within a team.

Benefits:

Why Choose Verista?

  • Opportunities for growth in a dynamic, people-oriented organization.
  • Competitive compensation with performance-based incentives.
  • Comprehensive company-paid insurance plans.
  • Health savings and retirement plans with employer matching.
  • Generous paid time off and holiday policies.
  • Tuition reimbursement and professional development opportunities.
  • Engaging team activities and employee recognition programs.
  • Supportive parental leave and bereavement policies.

For more information about our company, please visit us at our website.

  • Lead GxP Compliance Auditor

    1 week ago

    Las Vegas, Nevada, United States Verista Full time

    Job OverviewVerista is home to a team of 600 professionals dedicated to partnering with leading brands in the life sciences sector to address their operational challenges. Our mission is to foster growth and innovation within the scientific landscape, assisting researchers and organizations in tackling critical healthcare issues. We deliver cutting-edge...

  • Senior GxP Compliance Auditor

    1 week ago

    Las Vegas, Nevada, United States Verista Full time

    Job OverviewVerista is a leading consultancy with a team of 600 professionals dedicated to partnering with prominent brands in the life sciences sector. Our mission is to foster growth and innovation within the scientific community, assisting researchers and organizations in addressing critical healthcare challenges. We deliver tailored solutions and...

  • Senior GxP Quality Auditor

    2 weeks ago

    North Las Vegas, Nevada, United States LS Solutions Full time

    Job OverviewPosition: Principal Quality/GxP AuditorWe are seeking a highly experienced professional with over 10 years of proven expertise in the following areas:FDA Regulations: In-depth knowledge of laws, policies, and provisions related to section 503B of the FD&C Act.Good Manufacturing Practices: Familiarity with Title 21 CFR Parts 210, 211, and 820.Risk...

  • Senior GxP Quality Auditor

    2 weeks ago

    North Las Vegas, Nevada, United States LS Solutions Full time

    Job OverviewPosition: Principal Quality/GxP AuditorThe ideal candidate will possess over a decade of proven expertise in:FDA Regulations: Comprehensive understanding of laws, policies, and provisions pertinent to section 503B of the FD&C Act.Good Manufacturing Practices: In-depth knowledge of Title 21 CFR Parts 210, 211, and 820.GAP Assessments: Skilled in...

  • Compliance Auditor

    2 weeks ago

    Las Vegas, Nevada, United States Dotty's Full time

    Position Overview:As a key member of Dotty's financial team, the Compliance Auditor will be responsible for ensuring that all documentation adheres to regulatory standards and internal policies. This role is essential in maintaining the integrity of our financial operations.Key Responsibilities:Conduct thorough audits of documentation to ensure compliance...

  • Healthcare Coding Compliance Auditor

    1 week ago

    Las Vegas, Nevada, United States AMS Florida Full time

    Job OverviewPosition SummaryThe Healthcare Coding Compliance Auditor at AMS Florida plays a vital role in ensuring the precision of medical coding and billing operations. This position is essential for maintaining adherence to coding regulations, which significantly influences billing integrity and the financial stability of our organization.Core...

  • Lead Safety Compliance Officer

    2 weeks ago

    Las Vegas, Nevada, United States NV Energy Full time

    Company: NV EnergyPosition Title: Senior Safety SpecialistJob Overview: The Senior Safety Specialist is responsible for overseeing a comprehensive range of safety services and initiatives. This role involves the development, communication, and facilitation of training programs for employees, contractors, and the public, ensuring adherence to established...

  • Lead Safety Compliance Officer

    2 weeks ago

    Las Vegas, Nevada, United States NV Energy Full time

    NV EnergyPosition Title: Senior Safety SpecialistOverview: The Senior Safety Specialist plays a crucial role in overseeing and managing a comprehensive range of safety services and initiatives. This position is responsible for educating employees, contractors, and the public on safety protocols and best practices to ensure a secure working environment. The...

  • Lead Safety Compliance Officer

    2 weeks ago

    Las Vegas, Nevada, United States NV Energy Full time

    NV EnergyPosition Title: Senior Safety SpecialistJob Overview: The Senior Safety Specialist plays a crucial role in managing and overseeing comprehensive safety initiatives within the organization. This position is responsible for the administration and coordination of various safety services and programs aimed at fostering a safe working environment for all...

  • Non-Gaming Revenue Auditor

    1 week ago

    Las Vegas, Nevada, United States SAHARA Las Vegas Full time

    About SAHARA Las Vegas SAHARA epitomizes the timeless soul of Las Vegas. With a bold, sophisticated flair and a boutique approach to personal service, SAHARA provides guests with an intimate and unexpected experience that sets a new standard for Vegas. Completely remodeled and reimagined for a new era, SAHARA offers three distinctive hotel towers, a variety...

  • Compliance Marketing Specialist

    5 days ago

    Las Vegas, Nevada, United States Great Gray, LLC Full time

    About Great Gray, LLCGreat Gray, LLC is a leading provider of trustee and administrative services to Collective Investment Trusts (CITs), with over $190 billion in CIT assets, across more than 700 funds. We proudly work with 75 subadvisors, including leading firms such as Alliance Bernstein, American Funds, BlackRock, Franklin Templeton, MetLife, Neuberger...

  • Compliance Marketing Specialist

    5 days ago

    Las Vegas, Nevada, United States Great Gray, LLC Full time

    About Great Gray, LLCGreat Gray, LLC is a leading provider of trustee and administrative services to Collective Investment Trusts (CITs), with over $190 billion in CIT assets, across more than 700 funds. We proudly work with 75 subadvisors, including leading firms such as Alliance Bernstein, American Funds, BlackRock, Franklin Templeton, MetLife, Neuberger...

  • Global Treasury Lead

    5 days ago

    Las Vegas, Nevada, United States Aristocrat Full time

    About the RoleWe are seeking a highly experienced Senior Manager to lead our Global Treasury Operations team. As a key member of our finance team, you will be responsible for providing strategic guidance and direction to the team, ensuring the effective management of our global treasury operations.Key ResponsibilitiesLeadership and GuidanceProvide direction...

  • Logistics Compliance Coordinator I

    2 weeks ago

    Las Vegas, Nevada, United States Bluberi Gaming USA Inc Full time

    Job OverviewBLUBERI PRINCIPLES:Innovative ThinkingTransparency and ClarityIdentify, Resolve, and Take OwnershipOperational ExcellenceSeamless Business InteractionsTeam CollaborationAcknowledge Achievements, Yet Strive for MorePosition Summary:The Logistics Compliance Coordinator is tasked with dispatching notifications to gaming authorities and maintaining...

  • Healthcare Finance Manager

    2 weeks ago

    Las Vegas, Nevada, United States My Next Career Path Staffing Full time

    Position Summary My Next Career Path Staffing is seeking a skilled and experienced Healthcare Finance Manager to oversee the financial operations of our client, a leading healthcare organization. This role will play a crucial part in ensuring the accuracy and integrity of financial data while adhering to all relevant regulations and...

  • Compliance Officer

    3 days ago

    Las Vegas, Nevada, United States AskDegree, LLC Full time

    Job DescriptionAbout Us:At AskDegree LLC, we are a leading provider of compliance and security solutions, dedicated to democratizing access to the tools and services that enable businesses to thrive in the financial services industry.Our Mission:We aim to help our partners achieve operational excellence by leveraging our compliance services to deliver...

  • Senior Tax Consultant

    2 weeks ago

    Las Vegas, Nevada, United States Jobot Full time

    Tax Manager Opportunity with a Leading Accounting FirmOverview:This position is for a seasoned Tax Manager to become a vital part of a reputable accounting firm known for its commitment to excellence and professional development. The firm has a rich history of delivering tailored tax, accounting, and financial solutions to businesses and their...

  • Senior Tax Consultant

    2 weeks ago

    Las Vegas, Nevada, United States Jobot Full time

    Tax Manager Opportunity with a Leading Accounting FirmThis position is hosted by Jobot.About the Firm:Our client has been delivering tailored tax, accounting, and financial guidance to privately held enterprises and their proprietors for over 34 years. They focus on income and estate tax planning along with asset protection. The firm fosters professional...

  • Lead Electrician

    17 hours ago

    Las Vegas, Nevada, United States Helix Electric Full time

    Job SummaryWe are seeking a highly skilled and experienced Lead Electrician to join our team at Helix Electric. As a key member of our production-driven team, you will be responsible for supervising a crew of electricians and ensuring the successful completion of electrical installations and troubleshooting projects.Key ResponsibilitiesSupervise and lead a...

  • Senior Tax Consultant

    2 weeks ago

    Las Vegas, Nevada, United States Jobot Full time

    Tax Manager Opportunity at a Leading Accounting FirmThis position is hosted by: JobotSalary: $130,000 - $145,000 per yearAbout the Firm:Our client has been delivering tailored tax, accounting, and financial guidance to closely held enterprises and their proprietors for over 34 years. The firm emphasizes income and estate tax planning along with asset...