Essential Duties and Responsibilities include the following (other duties may be assigned):
•Provides expertise and guidance on GCPs and applicable regulations to specialty pharma/clinical development teams to proactively identify compliance issues/risks and recommend mitigation.
•Writes, reviews and revises SOPs related to clinical trials according to applicable global GCP regulations.
•Maintains the Quality Management System (QMS) for all SOPs and other controlled documents for specialty pharma.
•Develops and facilitates GCP/GXP training for functional areas and personnel involved in the execution of clinical trials.
•Leads regulatory inspection preparation activities and provides leadership and oversight during GCP inspections.
•Develops and implements risk-based GCP audit and compliance strategy.
•Supports creation of QA audit schedule for vendors, service providers and clinical sites in support of clinical trials.
•Assesses impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations.
•Reviews and provides input to clinical documentation (e.g. protocols, study reports, IBs, etc.).
•Leads investigations into significant quality issues, scientific misconduct and suspected breaches of GCP; facilitates identification of root cause and development of corrective/preventive actions; tracks actions and confirm effectiveness; ensures reporting of potential or confirmed violations to regulatory authorities, as appropriate.
•Supports internal audits and process audits of GCP areas, as needed.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Strong knowledge of US and international GCP requirement practices, global regulations regarding clinical development, auditing and regulatory inspection is required.
•Ability to work in a dynamic, start-up organization with aggressive timelines and multiple deliverables.
•Must have professional communication skills, strong independent time management skills and the ability to manage multiple projects concurrently in an organized fashion.
•Strong technical writing skills; ability to write clear quality positions statements, risk-based audit reports, and procedures.
•Extensive experience in building GCP systems and processes.
•Bachelor's degree in Clinical or Scientific discipline. Advance degree preferred.
•Minimum of 10 years of experience in the pharmaceutical R&D industry, of which a minimum 8 years should be hands-on GCP Quality Assurance experience.
Travel: Ability to travel up to 20% (domestic and international)
Computer Skills: Microsoft Word, PowerPoint, Excel, TrackWise Digital preferred but not required