Senior Quality Auditor

Overview

Are you passionate about making a tangible impact in the clinical technology field? Do you thrive in dynamic environments where problem-solving and innovation are encouraged? If so, we have an incredible opportunity for you to consider.

• Client audit planning, hosting and report responses.
• Ensure all client findings are addressed and closed by their targeted due date.
• Provide guidance for issue resolution as applicable.
• Conduct lessons learned with auditees after audit completion.
• Prepare audit reports and certificates.
• Provide mentoring to junior auditors.
• Participate in continuous improvement of 4G Clinical procedures and the overall quality system.
• Monitor and analyze results of audits for trends. Work with the Quality Audit Manager for audit reporting and escalations to Quality Management.
• Participate in all regulatory inspections.

• A minimum of 6-8 years’ experience as a client audit host in a regulatory environment.
• 3-5 years’ experience with auditing Computer Systems Validation and RTSM is desired.
• Skills in audit planning, audit conduct, and audit management are essential.

• A bachelor’s degree in a life sciences or information technology field, or equivalent auditing experience is preferred.
• Membership in professional organizations such as the Society of Quality Assurance (SQA), American Society for Quality (ASQ), or Regulatory Affairs Professionals (RAPS) certification desired.

$89,000 - $105,000. The salary range listed above represents a good-faith estimate of the base pay for this role and is provided to comply with applicable laws and regulations. The actual base salary offered will depend on factors such as location, qualifications, experience, and skills.

4G Clinical is a global leader in randomization and trial supply management (RTSM) and supply forecasting optimization software for the life sciences industry, offering cloud-based, configurable solutions utilizing NLP to accelerate clinical trials. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia.

• Health, dental, and vision benefits
• Unlimited vacation days for salaried full-time employees
• FSA and dependent care accounts
• Company-paid disability and life insurance
• Global mental health benefit
• Generous 401k program
• Paid sabbatical program
• Option grants

4G Clinical is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by applicable law.