Job Summary:
Reporting to the Vice President of Quality, this position will be responsible for development, implementation and Quality Assurance (QA) oversight of systems and associated documentation for all phases of clinical drug development. The individual will assist in the development of the Evofem Clinical Quality System, and provide support of internal activities, as related to Good Clinical Practice (GCP) compliance.
Job Responsibilities:
• Develop and implement plan for generation of QA Standard Operating Procedures (SOPs) relating to GCP in alignment with the Quality System.
• Coordinate US and international investigator site QA audits with independent consulting group(s), to include additional site training, as necessary (i.e., inspection readiness).
• Conduct investigator site audits for early phase clinical studies, if required.
• Perform sponsor QA responsibilities where clinical trial project management, including QA, has been outsourced to a Contract Research Organization (CRO).
• Act as key QA representative to clinical sub-teams to provide leadership and guidance to Evofem clinical team regarding GCP and regulatory compliance.
• Review and approve clinical operations, clinical records management, and regulatory affairs SOPs as related to GCP compliance.
• Coordinate QA audits of clinical protocols, clinical study reports, and Trial Master Files for the Food and Drug Administration (FDA) and International Council on Harmonization (ICH) compliance.
• Coordinate and/or perform vendor audits, as required, central laboratories, clinical CROs, as well as clinical data management CROs and Electronic Data Capture (EDC) vendors.
• Establish and conduct inspectional readiness training for Evofem clinical team.
• Review and approve clinical documents that will be submitted to regulatory authorities (i.e., Clinical Study Reports (CSRs), clinical protocols, Investigators Brochures (IBs), BLSs).
• Track and report monthly progress regarding closure of outstanding audit findings.
Competencies:
• Excellent interpersonal, communication, analytical and managerial skills.
• Strong attention to detail, establishing priorities, scheduling and meeting deadlines.
• Ability to work in a fast-paced environment.
• Demonstrated ability to manage multiple completing tasks and demands.
• Ability to work independently, take initiative and complete tasks to deadlines.
Education and Qualifications:
• Bachelor’s degree required, Master’s degree or higher preferred, in a scientific discipline or equivalent with 5-8 years pharmaceutical industry experience with QA and/or clinical operations background, GCP auditing, and participation in regulatory agency inspections.
• Must have the ability to apply quality system concepts to daily GCP operations. Strong understanding of applicable regulations (GCP, FDA, European Medicines Agency (EMEA) and ICH guidelines, etc.).
• Knowledgeable in advocating proactive measures to ensure GCP compliance and ability to consistently demonstrate the value of GCP QA to internal and external customers.
• Outstanding auditing skills, attention to detail and a clear comprehension of the regulatory basis and risk to the Company associated with audit findings.
• Expertise in reviewing, modifying and writing Standard Operating Procedures (SOPs).
• Ability to work both independently with direction and within project teams to attain team goals.
• Excellent interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and consulting staff at all levels of the Evofem organization, as well as vendors and clinical sites.
• Some scheduled travel may be required (site and vendor audits, investigator meetings, inspectional readiness for clinical sites).
Travel:
• Ability to travel up to 20% – domestic and international