Senior QA Manager, GCP
Senior QA Manager, GCP
Top Technical Skills:
• Must have a solid background within quality assurance
• Auditing experience and Clinical experience
• Must be hands-on and must be a quick learner
• Someone that is currently doing audits within GCP.
Senior Manager QA, GCP 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 and GLP compliance systems in support of all phases of the company clinical and non-clinical trials.
This individual needs the ability to manage quality system audits, including conducting audits when needed, to assure that all vendors are assessed for compliance with all applicable regulations, guidances/guidelines and SOPs; including audit conduct, reporting, follow-up, and tracking to closure. This position will partner with the clinical and non-clinical teams to identify new vendors, or new services to be utilized from existing vendors, and assess the associated risk and potential audit requirements.
• 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, and 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.
• Manage the resolution of compliance issues identified at clinical and non-clinical vendors and clinical sites and provide assessment of the impact of any deficiencies.
• Manage and conduct audits of documents for the Clinical department (e.g. protocols/study plans, clinical and nonclinical study reports, trial master files) and provides guidance and feedback.
• Develop and implement improvements to internal programs as indicated by audit observations, new regulations, guidance documents, and industry standards.
• Ensure that the GCP Approved Vendor List is created and updated as needed and posted to the electronic database.
• 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.
EDUCATION AND EXPERIENCE
• 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 Guidances/Guidelines.
• Working knowledge of quality risk management concepts.