Reports to: Senior Vice President, Quality
Who we are:
If you’re looking for a typical biotechnology company, you’ve come to the wrong place.
We are a revolutionary biotherapeutics company and our mission is to revolutionize autoimmune and allergic disease treatment by resetting the immune system for superior long-term disease remission
By developing therapies that achieve superior long-term disease remission from less frequent chronic dosing and without suppression of the immune system. A goal that others haven’t been able to reach.
Existing therapies for autoimmune and allergic diseases require frequent chronic dosing, provide only short-term disease remission in a limited number of patients and suppress the immune system, ultimately putting patients at risk of developing serious infections and life-threatening side effects.
How you’ll contribute:
Reporting to the Senior Vice President of Quality, the Associate Director of Quality Assurance (GCP) will lead and manage GCP-regulated quality assurance activities for Revolo’s development programs. This position works collaboratively with the clinical study team including Revolo personnel, vendors, and clinical investigator sites.
Principal Duties and Responsibilities:
- Develop and implement risk-based audit plans for GCP-regulated activities.
- Conduct and/or manage the planning, conduct and follow-up activities of audits for vendors, contract research organizations (CROs), clinical investigator sites, trial master file, and other documents.
- Serve as the primary QA lead on clinical project teams.
- Support the development and maintenance of the quality management system.
- Provide guidance and training on the interpretation of applicable regulations and industry best practices.
- Manage and approve quality events, including deviations, investigations, and corrective and preventive actions.
- Facilitate clinical inspection readiness activities.
Minimum Education, Training, and Experience Required:
- BS degree in a science-based subject or equivalent experience.
- Quality Assurance auditor certification is preferred.
- 5+ years of clinical compliance or QA experience in pharmaceutical or biotech industries.
- Strong working knowledge of regulatory requirements and guidance (ICH, FDA, MHRA, EMA) pertaining to Good Clinical Practice.
- Significant experience conducting audits as a lead auditor is required.
- Ability to identify issues, opportunities, and effective solutions and collaborate with others to improve processes and/or results.
- Willing to travel domestically and internationally as needed (up to 15%).
This position requires extended periods of sitting and working on a computer. Must have the ability to navigate travel both internationally and domestic.
Revolo Biotherapeutics is an Equal Opportunity/Affirmative Action Employer – EOE Minorities/ Females / Protected Veterans / Individuals with Disabilities.