Senior Quality Auditor (Hybrid Role)

Brief Description

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.

We are currently seeking a talented individual to join our Quality team as a Senior Quality Auditor.

The Senior Quality Auditor Is Responsible For The Following

• Host and support client audits in support of 4G Clinical's technology
• Conduct internal audits of all corporate products and areas related to 4G Clinical’s product and services offerings, including but not limited to: product development and study development software lifecycle, training, data audits, product releases, and change control.
• Provide guidance for issue resolution as applicable, and work with Computer Systems Validation (CSV) group to ensure resolutions include maintaining the validation of products and studies.
• Conduct lessons learned with auditees, as appropriate, after audit completion.
• Audit to regulations, procedures, and industry best practices.
• Prepare audit reports and certificates.
• Provide mentoring to junior auditors.
• Participate in continuous improvement of 4G Clinical procedures and overall quality system.
• Monitor and analyze results of internal audits for trends and escalations to Quality Management.
• Assist in all regulatory inspections.
  
  

This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs

Requirements

• The position requires a minimum of 5 years’ experience as an auditor in a regulatory technical environment.
• Experience auditing Computer Systems Validation and RTSM is desired.
• Skills in audit planning, hosting and conducting audits, and audit management are essential.
  
  

Education And/or Certificate Requirements

• The candidate must possess a bachelor’s degree in a life sciences or information technology field, or equivalent auditing experience.
• Membership in professional organizations such as the Society of Quality Assurance (SQA), or Regulatory Affairs Professionals (RAPS) certification desired.
  
  

Compensation: $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 the candidate’s location, qualifications, experience, and skills

Summary

4G Clinical is honored to be part of Fast Company's 2020 Best Workplaces for Innovators list, citing businesses and organizations that demonstrate a deep commitment to encouraging innovation at all levels. 4G Clinical came in at #8 for its dedication to building a culture that fuels innovation, curiosity, and the spirit of experimentation in all facets of the business from product development and brand to services and staffing. We were also voted one of the 2018 Best Places in Health Care & Biopharma by Great Place to Work® and FORTUNE.

About Us

4G Clinical is a global leader in randomization and trial supply management (RTSM) and supply forecasting optimization software for the life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solutions utilizing natural language processing (NLP) to accelerate clinical trials. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia.

For U.S.-based candidates, we offer compelling benefits to our employees, including:

• 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, and it is foundational to how we recruit and hire our talented team. 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.