The incumbent is responsible for planning and conducting GxP audits (i.e. clinical vendors, investigator sites, quality systems, etc.) in addition to supporting clinical manufacturing operations. The Quality Assurance team supports Avanir throughout the product development and commercial life cycle by providing appropriate knowledge/expertise/input, by communicating effectively internally and with external stakeholders and by ensuring that Avanir operates within relevant regulations. As part of Quality organization, this position will be responsible for planning, scheduling, communicating, conducting, and reporting global GCP audits of Clinical Vendors, Investigators Sites, Clinical Development and Operations, Data Management) in accordance to global GCP regulations. This role may be required to provide tactical and technical/operational guidance regarding GCP in compliance with current regulations. The incumbent will work closely with the Quality leadership and other cross-functional Department Leaders in Clinical to communicate GCP Audit plans and audit findings.
Essential Job Functions and Desired Accomplishments
Education/Qualifications/Certifications (Knowledge, Skills, Abilities, etc.) -
- Develop audit plans and perform Quality audits of clinical investigator sites, clinical vendors, data management, and internal clinical systems/operations
- Document and report quality /compliance issues relating to the clinical study, clinical trial material or clinical system
- Manage post-audit activities and follow-up on any necessary corrective and preventive actions
- Gather and interpret regulatory intelligence, as well as evaluate internal practices, make recommendations for improvement and execute against action plans
- Interpret policies, standards and regulations and evaluate potentially critical problems not covered by policies, standards and regulations
- Exercise judgment in ensuring that written procedures are followed
- Evaluate quality systems, processes, procedures and protocols for compliance
- Develop internal SOPs, policies and procedures as required
- Where required, draft quality agreements with Clinical Vendors
- Track, trend GCP Audit KPI Metrics
- Escalate regulatory compliance risks to Quality and Clinical Leadership to ensure that all issues are mitigated in a timely manner.
- 30% travel both domestically and internationally
Physical Requirements and Work Environment Physical Requirements:
- BS/BA degree
- Certified Auditor is preferable
- 10+ years of experience in pharmaceutical industry
- 5+ years of experience in GCP auditing, GMP and GLP auditing experience will be added benefit.
- Working knowledge of GxPs and quality systems
- Must be able to effectively collaborate with others and work in a matrixed team
- Must be flexible, resourceful, and multitask efficiently
- Excellent project management skills is a must
This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver's license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.Work Environment:
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.
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This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
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