Lead the Quality Assurance (QA) and Compliance function to develop, implement, monitor, and maintain quality systems and policies and to ensure compliance risks are identified and mitigated.
Job Duties/ Main Responsibilities
- Serve as the regulatory and quality resource for all functional areas of the company.
- Experience in working with clients and other external parties.
- Provide strategic quality consultation to Sr. Management.
- Oversee all aspects of the Quality Management System (QMS).
- Serve as quality point of contact for third party audits and regulatory inspections.
- Perform or actively lead internal QMS and validated system audits to ensure compliance with applicable regulations and standards.
- Perform vendor qualification audits.
- Conduct external (site and vendor) audits to identify issues using root cause analysis techniques to ensure continuous quality improvements.
- Review vendor supplied data and quality records for conformance to Good Documentation Practices (GDP).
- Responsible for the development and management of all company-wide Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).
- Develop and maintain Good Clinical Practice (GCP) and Good Pharmacoepidemiology Practices (GPP) compliance processes, as applicable, which control the quality of work.
- Knowledge of GCP/GPP guidances and regulations and inform management and program teams of issues as appropriate.
- Provide support and advice during cross functional investigations, projects, third party audits and regulatory inspections.
- Support special projects requiring QA input.
- Provide training in all aspects of the Quality Management System.
- Assist with management of contract auditors.
- Participate in team meetings/discussions as requested.
- Perform other related duties as assigned.
Education and Experience
Bachelor’s degree in a Life Sciences discipline or other related field. 8 years of experience in compliance activities across different sized organizations (such as both biotechnology and pharmaceutical companies). Experience in real world evidence, registries, observational studies, or non-interventional research is strongly preferred. Experience working with clients and external parties strongly preferred.
Knowledge, Skills, and Abilities
Good working knowledge and understanding of clinical research. Good knowledge of industry standards and regulation requirements for clinical studies. Expert knowledge of GxP regulations and good documentation practices. Strong analytical, written and verbal communication skills. Strong Microsoft Office skills. Strong ability to be detail oriented. Demonstrated ability to successfully partner with and provide guidance to multi-disciplined teams from project inception through project completion with respect to FDA requirements, agency inspections and vendor audits, and corrective actions.