Manager, GCP Quality Assurance

The Quality team supports Avanir throughout the product development and commercial life cycle by interacting with regulatory agencies, facilitating regulatory activities, preparing regulatory documentation, and coordinating company-wide interactions. This is accomplished with a thorough understanding and knowledge of quality requirements to support and ensure that Avanir operates within and in compliance with applicable regulations. This position will manage Quality oversight of Avanir’s Pharmaceuticals Clinical Operations programs to ensure compliance with global GCP regulations. The role will partner with Clinical Operations to provide strategic, tactical, and operational guidance regarding GCP compliance with current pharmaceutical laws and regulations. This role is instrumental in integrating quality throughout all steps of the clinical study process, including monitoring, auditing using risk assessments, and trending key metrics to drive continuous improvement in compliance and quality.

Essential Job Functions:

• Collaborate with Clinical Development and Clinical Operations functions to confirm adherence to GCP compliance through all stages of clinical trial conduct including but not limited to: core study execution documents, clinical trial sponsor oversight, issue escalation, internal/external audit support.
• Manage the auditing process and other GCP QA inspectional activities
• Review supportive clinical trial documents (manuals, study plans) for compliance with regulations
• Maintain SOPs pertaining to Quality of GCP related activities
• Work with CROs to create, and keep current, Quality Agreements, Monitoring Plans, etc., to ensure quality standards are met, and resolve issues promptly and effectively
• Participate in the clinical supplier qualification program to ensure Sponsor Oversight of vendors
• Support the coordination and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections
• Ability to travel (domestic and international) up to 50% of the time

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Education/ Qualifications:

• Bachelor’s degree in Chemistry, Life Sciences, Engineering or related field
• 8+ years of experience in Clinical Quality Assurance or Clinical Operations in the pharmaceutical or biotechnology industry for a Senior Manager, and 5+ years of experience for Manager.
• Strong proven hands-on experience with a variety of GCP compliance matters and experience with all phases of clinical trials
• Knowledge of Good Clinical Practices (FDA and ICH), Pharmacovigilance (FDA and EMA), a solid understanding of 21 CFR Part 11 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, and eTMF requirements
• Must be able to effectively collaborate with peers and comfortable working in a matrixed team.
• Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner
• Must be solutions oriented and pragmatic
• Experience with GCP regulatory inspections preferred
• Certified Quality Auditor certification preferred
• Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)

Physical Requirements:

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.

EEO Statement:

As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.  All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination.  Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.

Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a).  These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.