Avanir Pharmaceuticals

Senior Manager, Quality Systems, Document Management and Records Retention

Location
Aliso Viejo, CA, United States
Posted
Oct 23, 2020
Ref
R2510
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
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.

The incumbent will be responsible for working closely with the Executive Director, Quality in the development, management, execution, and compliance of Avanir's Document Management and Records Management Systems

Essential Job Functions:
  • Provides quality oversight to ensure compliance with government regulations, internal standards and applicable regulations with Document Management and Records Retentions.
  • Interact with government agencies during GMP inspection. Act as the Back-Room Manager and Subject Manager Expert to ensure accurate, timely production of documents provided to support regulatory inspection.
  • Develop, improve, implement, and manage an effective and holistic documentation management and change control system to ensure all GxP and non-GxP documents are initiated, reviewed, approved, and archived in compliance with regulatory and company policies and procedures.
  • Active participant in audits and inspection readiness activities to ensure Avanir is in a constant state of inspection readiness.
  • Provide leadership in establishing and maintaining Good Documentation Policies, provide GDP Training, and ensure documentation integrity is maintained by Avanir Staff by ensuring biennial review and updates of documents.
  • Chair a Change Control Board whereby all documents are reviewed and approved to ensure timely cycle times of documentation.
  • Collect, prepare, and report accurate documentation cycle time related metrics and KPI's to management meetings, monthly.
  • Provide budgetary estimation of quality-related expenses.


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, or Engineering or related field.
  • 10+ years of experience in pharmaceutical industry with at least 7 years of Quality Systems experience.
  • Experience in Document Management system and had successful track of defending Documentation and Change Control Management and global regulatory audits.
  • Experience with Veeva and TrackWise a plus.
  • Strong working knowledge of cGMPs and technical expertise in laboratory quality systems required.
  • Have successfully managed EDMS
  • Must have excellent computer, written and verbal communication skills.
  • Must have a successful track of interacting with regulatory authorities and act as SME.
  • Must be able to effectively collaborate with peers and comfortable working in a matrixed team.
  • Must be solutions oriented and pragmatic
  • Excellent project management skills are a must


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.