Senior Quality/GxP Auditor - 4447
Verista, United States
Job Description
Verista’s600 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 amp; 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
Senior Quality/GxP Auditor Responsibilities:
Responsible for planning and conducting scheduled quality audits on behalf of clients. This position will also act as a Subject Matter Expert (SME) for GxP/CSV auditing and projects within the Regulatory, Quality Compliance and Auditing Service Line within Verista. This position is responsible for independently managing quality/GxP auditing deliverables and providing consulting services to clients as requested and scheduled.
• Function as a subject matter lead for Quality/GxP auditing projects within Verista.
• Coordinate and deliver on audit logistics and deliverables.
• Execute audits (remote or onsite) based on experience, client requirements and a comprehensive understanding of all federal regulatory requirements and ICH (International Council for Harmonization) guidance.
• Ensure audits are performed to a high degree of client satisfaction and within the budgeted time.
• Facilitate post-audit debriefs with clients within defined timeframes ensuring clear communication of audit findings.
• Produce draft and final versions of audit reports and documents within defined timeframes.
• Review audit responses to observations identified in final report.
• Promote continual improvement regarding customer satisfaction with emphasis on Quality/GxP auditing services.
• Stay current with advances and technological changes in Quality/GxP services within the pharmaceutical / device / biotech industries and promote those that will increase the service lines effectiveness and knowledge.
Requirements
Required, Encouraged and Preferred Knowledge/Experience
• B.S./B.A. in scientific discipline as a minimum.
• Minimum of 10 years of GxP auditing experience in related industry with a significant amount of time spent conducting CSV/SDLC auditing.
• Minimum of 14 years of experience within Pharmaceutical / Biotech / Medical Device industry.
• Excellent knowledge of GxP regulatory requirements.
• Demonstrated success in earning and maintaining a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.
• Proven record of teamwork, problem solving, project tracking and facilitation of efficient communication between the client and the team.
• Experience creating and working with high performance teams.
• Quality orientation and high attention to detail.
• Demonstrated ability to work with others and drive results.
• Ability to think ahead and prepare sound action plans to achieve results.
• Audit certification from reputable agency required
• Demonstrated Data Integrity (DI) Expertise encouraged
• Demonstrated Artificial Intelligence (AI) amp; Machine Learning Experience/Auditing - encouraged
• Demonstrated GCP Auditing Experience - preferred
Required Skills and Abilities
• Capacity to make independent sound decisions and independently manage priorities.
• Ability to interact in a professional and positive manner with clients and co-workers.
• Exceptional communicator with strong persuasion skills and presentations.
• Excellent interpersonal and communication skills both written and verbal.
• Ability to write concise, accurate reports and other necessary documentation.
• Ability to provide and receive constructive feedback.
• Ability to organize and manage multiple projects.
• Excellent analytical skills and the ability to assess large quantities of information efficiently and effectively.
• Ability to read, prepare and analyze data for development of reports; ability to sit