150 applicants

Company

Parexel · 4 days ago

Sr Technology Auditor

United States

Full-time

Remote

Senior Level

5+ years exp

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Pharmaceutical Manufacturing

Actively Hiring

Hiring Manager

Eileen Campbell

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Responsibilities

Lead, perform and report on Technology audits (Veeva, Medidata Rave, Servers, Data Centers, AI suppliers, Information Security, etc.)

Manage Technology audits

Lead and coordinate internal audit programs (global and regional)

Support Serious Breaches

Support Auditor Training and Mentoring

Maintain QA Records / Systems

Support Sponsor Audits and Regulatory Inspections

Maintain sound knowledge of Parexel policies, procedures, and guidelines and promote compliance within Parexel

Build, develop, and maintain working relationships with internal and external customer groups

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Technology auditsGxP knowledgeClinical trial technologyMicrosoft applicationsProject management

Required

Experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of internal and supplier technology audits

High degree of flexibility and initiative

Ability to follow up on multiple tasks and projects

Ability to handle confidential information diplomatically

Capability of traveling up to 25 - 50% of the time

Lead, perform and report on Technology audits (Veeva, Medidata Rave, Servers, Data Centers, AI suppliers, Information Security, etc.)

Manage Technology audits

Lead and coordinate internal audit programs (global and regional)

Support Serious Breaches

Support Auditor Training and Mentoring

Maintain QA Records / Systems

Support Sponsor Audits and Regulatory Inspections

Maintain sound knowledge of Parexel policies, procedures, and guidelines and promote compliance within Parexel

Build, develop, and maintain working relationships with internal and external customer groups

Excellent interpersonal, verbal and written communication skills

Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

Experience with Microsoft based applications and ability to learn internal and supplier computer systems

Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork

Ability to develop relationships with culturally diverse stakeholders, including Parexel team members and sponsor representatives

Ability to work professionally with highly confidential information

Flexibility and ability to adjust to changing priorities and unforeseen events

Excellent time management skills and the ability to follow-up on multiple tasks and projects

Ability to diplomatically address sensitive issues confidentially and professionally

Ability to work consistently in a fast-paced environment

Strong knowledge of GxP, industry standards, applicable international technology compliance regulations

Must be detail oriented and able to maintain a ‘big picture’ overview during a sponsor audit or inspections

Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically

Familiar in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems

Five to nine years of experience in Quality Assurance, auditing, relevant Quality Management and clinical trial support

Preferred

Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience

Company

Parexel

Glassdoor

3.9

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster.

Founded in 1983

Durham, North Carolina

10,001+ employees