Jobs
>
Raleigh

    Lead Quality/GxP Auditor - Raleigh, United States - Verista

    Verista
    Verista Raleigh, United States

    5 days ago

    Default job background
    Description
    Verista's 600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

    Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

    Company Culture Guidelines & Values:
    • We empower and support our colleagues
    • We commit to client success at every turn
    • We have the courage to do the right thing
    • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
    • We constantly acquire new skills and learn from our experiences to enhance our collective expertise
    Lead Quality/GxP Auditor Responsibilities:
    • Identify, analyze, and determine solutions regarding capability gaps
    • Partner with the business to define what a qualified RTP team member looks like based on their job responsibilities - then design an appropriate curriculum
    • Create, revise, and implement training and related documents, ensuring they are well written, executable, and compliant with applicable policies/procedures
    • Facilitate the review of documents and training materials to ensure compliance and learning requirements are met
    • Ensure that training solutions are aligned to global strategy where appropriate by proactively connecting with the Global L&D organization
    • Ensure that current training courses/interventions are effective - and if not, identify an alternative and implement
    • Proactively identify areas where capability challenges exist and design interventions on how to reduce those issues
    • Define ongoing ownership and maintenance plan for L&D interventions
    • Monitor learning budget for projects within assigned business area/function as applicable
    • Create initial project scope documents, appropriately leveraging learning services suppliers for outsourced work to achieve business objectives
    • Create, review and oversee execution of implementation plan(s), ensuring effective coordination with personnel who create and revise business area/function SOPs and other documents
    • Monitor and communicate program/portfolio status to key business partners
    • Anticipate and resolve project/program issues, escalating as appropriate
    • Oversee portfolio of projects to ensure on-time, on-budget creation of deliverables that meet quality standards, follow instructional design principles, are approved by appropriate personnel, and meet needs of business (including translations and any "Corporate Initiative" requirements)
    • Drive quality standards through review of project documents, design, deliverables, final learning content and evaluation data
    • Think strategically about the best way to train our team members - not just what has been done, but the best way to get them effectively trained and able to use their knowledge quickly
    • Benchmark cross functionally within Lilly as appropriate, seeking sharing and replication opportunities
    • Establish strong relationship with suppliers and Lilly supplier management contacts to align on portfolio of projects and services and ensure seamless quality of deliverables
    • Conduct usability testing as required
    • Share business metrics, interpretations, and solutions with Supervisor, business partners/process team
    • Participate regularly in area/function project and process teams.
    • Understand RTP functions deeply, including business goals, job titles and descriptions, key duties, and responsibilities
    • Monitor RTP team members' satisfaction of learning programs and use that feedback to improve our programs
    • Consult across the assigned business area/function and the Lilly learning community to ensure training plans align with business plan, strategic direction, and compliance and ethics
    • Influence your RTP team leaders to think about the most efficient and effective way to deliver training interventions that are meaningful, useful, and relevant to their roles
    • Manage suppliers working on L&D related projects to ensure delivery and performance mirrors or exceeds our agreements; ensure that the deliverables meet the needs of our site team members
    Requirements
    • B.S./B.A. in scientific discipline as a minimum
    • Minimum 3 years of GxP auditing experience in related industry
    • Minimum of 5 years of experience within Pharmaceutical / Biotech / Medical Device industry
    • Experience working in a GxP (regulated) environment.
    • Experience in technical writing
    • Demonstrated program/project management skills
    • Experience with learning & development business processes
    • Demonstrated ability to establish strong business relationships
    • Demonstrated ability in communication, conflict resolution, and judgment and managing complexity
    • Working knowledge of business area/function
    • Experienced in Vendor management
    • Ability and willingness to challenge business partners regarding ways to use learning interventions to most effectively meet business requirements
    • Ability to work independently and in a team environment.
    • Strong start-up mindset - think deliver execute review cycle
    • Strategic operator - think of where we need to go, but also the tactical ways to get there
    Benefits

    Why Choose Verista?
    • High growth potential and fast-paced organization with a people-focused culture
    • Competitive pay plus performance-based incentive programs
    • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
    • Medical, Dental & Vision insurances
    • FSA, DCARE, Commuter Benefits
    • Supplemental Life, Hospital, Critical Illness and Legal Insurance
    • Health Savings Account
    • 401(k) Retirement Plan (Employer Matching benefit)
    • Paid Time Off (Rollover Option) and Holidays
    • As Needed Sick Time
    • Tuition Reimbursement
    • Team Social Activities (We have fun)
    • Employee Recognition
    • Employee Referral Program
    • Paid Parental Leave and Bereavement
    For more information about our company, please visit us at

    For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

    $85,000 - $165,000

    *Verista is an equal opportunity employer.
  • Verista

    Lead Quality/GxP Auditor

    3 weeks ago

    Verista Raleigh, United States

    Job Description · Job DescriptionVerista's 600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help research ...

  • Verista

    Lead Quality/GxP Auditor

    1 week ago

    Verista Raleigh, North Carolina, United States Permanent

    Verista's 600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies ...

  • LS Solutions Inc

    Lead Quality/GxP Auditor

    4 weeks ago

    LS Solutions Inc Durham, United States

    Role: Lead Quality/GxP Auditor · Location: Durham, NC, Onsite) · Duration: 12 Months Contract · Job Description: · Identify, analyse, and determine solutions regarding capability gaps · Partner with the business to define what a qualified RTP team member looks like based on their ...

  • IAT Insurance Group

    Claims Quality Auditor Specialist

    4 days ago

    IAT Insurance Group Raleigh, United States

    IAT Insurance Group has an immediate opening for a Claims Quality Auditor Specialist located in our Raleigh, North Carolina office.Please note, IAT works on a hybrid schedule.This role will be required to work from the office Monday through Wednesday with the option of working re ...

  • IQVIA

    Quality Assurance Auditor 2

    2 weeks ago

    IQVIA Durham, United States

    We are seeking a Quality Assurance Auditor 2 to join Q2 Solutions, IQVIA's laboratory business in Durham, NC.We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us a ...

  • Antech Diagnostics

    Quality Assurance Auditor

    2 weeks ago

    Antech Diagnostics Morrisville, United States

    We understand that the world we want tomorrow starts with how we do business today, and that's why we're inspired to make A Better World for Pets. Antech is comprised of a diverse team of individuals who are committed to each other's growth and development. Our culture is centere ...

  • Antech Diagnostics

    Quality Assurance Auditor

    2 weeks ago

    Antech Diagnostics Morrisville, United States

    We understand that the world we want tomorrow starts with how we do business today, and that's why we're inspired to make A Better World for Pets. Antech is comprised of a diverse team of individuals who are committed to each other's growth and development. Our culture is centere ...

  • IQVIA

    Quality Assurance Auditor 2

    2 weeks ago

    IQVIA Durham, United States

    We are seeking a Quality Assurance Auditor 2 to join Q2 Solutions, IQVIA's laboratory business in Durham, NC. · We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join ...

  • SpiraTec AG

    MES Consultant for Manufacturing OT

    4 days ago

    SpiraTec AG Raleigh, United States

    · MES Consultant for Manufacturing OT (hybrid) at SpiraTec AG | softgarden · View job here MES Consultant for Manufacturing OT (hybrid) · Full Time · Raleigh, North Carolina, USA · Hybrid · With Professional Experience · 6/4/24 · Contact person · Recruiting Team International ...

  • Experis

    Calibration Technician

    2 weeks ago

    Experis Raleigh, United States

    Title : Calibration Technician · Location: · MUST BE LOCAL TO · RALEIGH, NC · Process Team / Analytical Team · The Calibration Technician (Tech I, Tech II, Tech III, Tech SR) reports directly to the Team Leader, Manager, or Director depending on the organizational structure. Thes ...

  • Precision Medicine Group

    Sr. Project Engineer I, Testing Engineering

    3 weeks ago

    Precision Medicine Group Raleigh, United States Full time

    Why Precision for Medicine? · Welcome to the forefront of innovation in cutting edge patient treatments We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science industry, we are constantly pushing the bound ...

  • Truist

    Audit Director Technology Cyber

    6 days ago

    Truist Raleigh, United States Full time

    ESSENTIAL DUTIES AND RESPONSIBILITIES · Charlotte NC - 214 North Tryon Street · Raleigh NC Beechleaf Court · Atlanta, GA - 303 Peachtree Street · Winston Salem, NC - 101 North Cherry Street · Richmond, VA.-1001 Semmes Ave. · This is not a remote position; we require candidates to ...

  • Siemens Energy

    Quality Manager in Projects

    2 weeks ago

    Siemens Energy Raleigh, United States Full time

    Quality Manager in Projects - Raleigh, NC · About the Role · Location United States of America North Carolina Raleigh Remote vs. Office Hybrid (Remote/Office) Company Siemens Energy, Inc. Organization EVP Global Functions Business Unit Project Entity Full / Part time Full-time ...

  • State Employees' Credit Union

    Auditor

    6 days ago

    State Employees' Credit Union Raleigh, United States Full time

    If you are motivated and believe in the credit union philosophy of "People Helping People," join our team · Position Overview: · To assist in the development, completion and documentation of risk-based internal audit assurance activites including financial, operational and compli ...

  • Artisan Design Group

    Senior Accounting Manager

    2 weeks ago

    Artisan Design Group Raleigh, United States

    JOB SUMMARYCurrently seeking an experienced Senior Accountant to join our team. Duties include completing monthly accounting records, reviewing journal entries, and guiding clerical staff while abiding by GAAP guidelines.ESSENTIAL DUTIES AND RESPONSIBILITIES · include the follow ...

  • Duke University

    Lead Sterile Processing Technician

    1 week ago

    Duke University Raleigh, United States

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. · About Duke Raleigh Hospital, A Campus ...

  • UCB

    Head of Quality Auditing GMP

    1 week ago

    UCB Raleigh, United States

    Make your mark for patients · We are looking for a Head of Quality Auditing GMP / GDP who leads with courage, drives change, and communicates clearly to join us in our Global Quality team, based in or close to our Atlanta, GA or Raleigh, NC office in the United States. We are a h ...

  • UCB

    Head of Quality Auditing GMP

    6 days ago

    UCB Raleigh, United States OTHER

    Make your mark for patients · We are looking for a Head of Quality Auditing GMP / GDP who leads with courage, drives change, and communicates clearly to join us in our Global Quality team, based in or close to our Atlanta, GA or Raleigh, NC office in the United States. We are a h ...

  • MMS

    Senior Quality and Compliance Specialist

    2 weeks ago

    MMS Raleigh, United States

    Job Description · Job DescriptionMMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-e ...

  • Katalyst Healthcares & Life Sciences

    CSV Consultant

    4 weeks ago

    Katalyst Healthcares & Life Sciences Raleigh, United States

    Responsibilities: · We are looking for a pure validation resource with periodic review, audit experience. · years' Experience in Validating GxP applications · Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validati ...