Senior QA Auditor (GCP Auditing)

Location: North Carolina, United States

Notice

This position is no longer open.

Requisition Number: 1562

Position Title: Senior Auditor, Audits and Inspections Program

External Description:

Why Worldwide? We are an award-winning organization that you can count on us for integrity, honesty, and consistency. We live by our mission to work with passion and purpose every day to improve lives. We have amazing people — smart, experienced, and united by a desire to change the course of medical science worldwide for patients and caregivers alike.

SUMMARY: The Senior QA Auditor is responsible for planning, executing, reporting, and following up on GxP QA Audits & supporting Regulatory Inspections as assigned.   Location: Remote USA

 

RESPONSIBILITIES:

 

  • Champions and adheres to Worldwide’s Quality Management System (QMS)
  • Serves as a positive ambassador of the QA organization with internal and external customers
  • Develops and executes personal and QA goals and objectives
  • Adheres to Worldwide travel policy and QA budgets
  • Performs QA audits for Vendors, Internal Process, Clinical Investigator, Document (Clinical Study reports, Trial Master File, Database) and other audits, as assigned
  • Ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes
  • Oversees, monitors, and reports on QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements
  • Oversees the maintenance and archiving of records for each audit
  • Participates in the driving continuous process improvements
  • Participates in the development and review of AIP Quality Management Documents, as assigned
  • Assists with tracking and reporting of Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program
  • Provides support to Sponsors Audits and Inspections in relation to Worldwide provided services
  • Assists with lessons learned opportunities following audits to allow for the transfer of knowledge and training
  • Ensures data and record management in accordance with the QMS
  • Assists in developing training material and/or delivers training related to audits and inspections
  • Serves as a Subject Matter Expert on QA Quality Management processes for audits
  • Communicates relevant regulatory intelligence that has an impact on the QMS to the QA team
  • Participates in employee performance appraisals as per Worldwide processes
  • Performs other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

 

OTHER SKILLS AND ABILITIES:

  • Ability to work with minimal supervision and guidance
  • Demonstrates excellent organizational leadership competencies, inclusive of scheduling and leading team meetings that are effective, efficient, and documented
  • Demonstrates excellent decision-making and project management skills
  • Demonstrates excellent ability to effectively communicate and influence the outcomes of the decision-making process
  • Communicates professionally, concisely, clearly, and consistently to external and internal customers both verbally and in writing
  • Acts with authority to drive performance and accountability
  • Ability to lead a team of individuals with a clear vision and defined purpose
  • Demonstrates excellent skillset for influencing, being resourceful, managing conflict, and negotiating
  • Demonstrates an excellent aptitude for facilitating group or project initiatives and building team unity
  • Works with a sense of urgency; ability to recognize time sensitivity and leads assertively
  • Demonstrates an excellent understanding of clinical research principles and processes for clinical trials
  • Demonstrates the ability to work collaboratively with cross-functional stakeholders to drive process improvements based on Quality Indicators
  • Demonstrates the ability to implement risk management strategies

 

REQUIREMENTS:

  • Possesses broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities
  • Excellent understanding of the principles for a GCP Quality Management System
  • Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree
  • Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP
  • Excellent experience in conducting QA Audits, specifically GCP for each type (i.e. Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For-cause Audits, Document Audits, etc.).
  • Excellent understanding of risk-based approaches to auditing
  • Previous experience in trending and analysis methodologies
  • Excellent understanding of the Drug Development Process
  • Ability to speak, read and write English fluently
  • M.S. in scientific or allied health field and 5+ years of relevant GCP, GcLP, GLP, GVP, and/or GPP experience

OR

Completed college curriculum, or equivalent,  with a concentration in nursing, biological, physical, health, pharmacy, or other related science and 4+ years of relevant GCP experience. Other GxP experience, including Computer Validation, is a plus.

  • Minimum 3 years of Quality Assurance auditing experience
  • IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint.
  • Domestic and international travel required (approximately up to 50%)

 

#LI-MS1

#IND-MS1

 

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Senior QA Auditor (GCP Auditing)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Research Triangle Park, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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© Worldwide Clinical Trials 2019

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.