Senior Manager, GCP QA
Waltham, MA | Contract
Sr. Manager, GCP Quality Assurance
Senior Manager, GCP Quality Assurance will manage quality system audits of external GCP vendors, internal GCP processes and documents, and clinical investigator sites. This position will establish, implement and maintain GCP quality systems in support of all phases of the company clinical and non-clinical trials.
• Manage and conduct quality system audits of GCP Vendors that have been contracted to conduct and/or manage clinical trial activities and clinical trial data generated to assess adherence to applicable regulations, guidance/guidelines, SOPs.
• Manage and conduct audits of internal processes and documents to assure compliance with all applicable regulations, standards, and SOPs.
• Manage and conduct audits of clinical investigator sites conducting trials to assess adherence to the Study Protocol and associated documents, the Study Audit Plan, applicable regulations, guidance/guidelines, and SOPs.
• Manage and conduct trend analysis of audit observations. Identifies and communicates to QA management all compliance risks.
• Represent QA on the clinical and non-clinical teams and provide compliance advice and guidance.
• Ensure that the GCP Vendor Audit Schedule is created and updated as needed and posted to the electronic database.
• Develop and implement relevant clinical and non-clinical QA standard operating procedures.
• Lead and/or participates in the company preparations for regulatory inspections.
• BS in a scientific discipline required. Experience in a regulated industry preferred.
• At least 5 years of QA experience in a GCP setting for all phases of clinical trials.
• Experience auditing GCP vendors who provide clinical trial and non-clinical study services, internal GCP processes and documents, and clinical investigator sites.
• Knowledge of FDA and global Regulatory Standards and associated Guidance’ s/Guidelines.
• Working knowledge of quality risk management concepts