Senior Auditor, Computer Systems Quality Assurance
Company: Syneos Health
Location: Flexible, with potential travel requirements (up to 50%)
About Syneos Health
Syneos Health is a global leader in biopharmaceutical solutions, specializing in clinical development, medical affairs, and commercialization services. The company is driven by the mission to accelerate the delivery of new therapies, with over 29,000 employees spanning 110 countries. Syneos Health is committed to innovation, collaboration, and fostering a culture that empowers its employees to make a significant impact on improving global health.
Why Syneos Health?
Career Growth: Focus on personal and professional development, with opportunities for progression, training, and recognition.
Inclusive Culture: Dedicated to creating a work environment where diversity, inclusion, and authenticity are at the core of everything they do.
Global Impact: Work alongside experts in the field, contributing to the development of novel therapies that change lives.
Role Overview
As a Senior Auditor, Computer Systems Quality Assurance, you will be responsible for planning, conducting, and overseeing audits related to computer systems within the biopharmaceutical industry. You will ensure that all computer systems comply with GxP (Good Clinical Practice) regulations and that audits are conducted efficiently. You will also support customer audits and regulatory inspections.
Key Responsibilities
Syneos Health Audits:
Plan and conduct audits, including For Cause audits.
Write and issue clear and concise audit reports, communicating findings effectively to both auditees and management.
Review responses to audit findings, ensuring that corrective actions are appropriate and complete.
Close audits once findings have been addressed.
Customer Audits & Inspections:
Prepare for and assist with customer audits, hosting them when needed.
Prepare for and support regulatory authority inspections.
Team Leadership:
Serve as a Lead Auditor on team-based Syneos Health audits.
Act as an Assisting Auditor for team-based audits when required.
Mentor and train less experienced Quality Assurance auditors.
Additional Responsibilities:
May be involved in writing, reviewing, or revising SOPs (Standard Operating Procedures) and Work Instructions.
Handle other assigned work-related duties as necessary.
Qualifications
Required Experience & Skills:
Bachelor’s degree in a science or healthcare field or equivalent experience.
5+ years of experience in GxP quality assurance auditing within the Pharma or CRO sector.
Proven ability to conduct various types of audits (e.g., vendor, process, computer system validation).
Experience with customer audits and supporting regulatory inspections.
In-depth knowledge of GxP regulatory requirements, especially in Computer Systems Quality.
Familiarity with ISPE GGAMP5 concepts is preferred.
Proficiency in Microsoft Office and SharePoint.
Strong organizational skills, with the ability to handle multiple tasks in a dynamic environment.
Excellent communication and presentation skills, with the ability to provide constructive feedback.
Other Qualities:
Ability to adapt to diverse cultural environments and communicate effectively across cultures.
Ability to negotiate and problem-solve in complex audit scenarios.
Compensation & Benefits:
Syneos Health offers a competitive salary based on experience and qualifications, along with a robust benefits package that includes:
Health, dental, and vision insurance.
401(k) with company match.
Flexible paid time off (PTO) and sick leave.
Opportunities for career growth, professional development, and industry recognition.
Apply Now to be part of an innovative team that works at the forefront of clinical research and helps bring life-changing therapies to market.
Syneos Health is an equal opportunity employer and values diversity in its workforce. Applicants from all backgrounds are encouraged to apply.
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