Avanir Pharmaceuticals

Senior Manager, Quality Assurance GMP

Location
Aliso Viejo, CA, United States
Posted
Oct 23, 2020
Ref
R2075
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The incumbent is responsible for managing the GMP operations and compliance of Avanir's Quality Management System as well as monitoring the compliance of contract service providers (i.e. contract manufacturers, contract laboratories, suppliers, distributors quality systems, etc.). 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 role may be required to provide tactical and technical/operational guidance regarding GMP in compliance with current regulations. This position will also be responsible for assisting with conducting GMP audits of contract manufacturers, contract laboratories, suppliers and distributors in accordance to global GMP regulations. The incumbent will work closely with the Quality leadership and other cross-functional Department Leaders in Technical Operations and Clinical Operations to communicate GMP Audit plans and audit findings.

Essential Job Functions:
  • Review and disposition manufacturing and packaging batch records
  • Document and report quality /compliance issues relating to the manufacturing, supply, and distribution of commercial and clinical materials and products
  • 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, and make recommendations for improvement of Avanir procedures.
  • 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 vendors
  • Track, trend GMP Audit KPI Metrics
  • Develop audit plans and perform Quality audits of contract manufacturers, contract laboratories, suppliers, and distributors
  • Escalate regulatory compliance risks to Quality, Clinical Operations, and Technical Operations to ensure that all issues are mitigated in a timely manner.
  • 10% travel both domestically and internationally


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 is required.
  • Certified Auditor is preferable
  • 12+ years of experience in pharmaceutical industry
  • 5+ years of experience in GMP 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
  • Must demonstrate excellent project management skills
  • Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, Visio, etc.).


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.