AlisoViejoRecruiter Since 2001
the smart solution for Aliso Viejo jobs

Director, GCP Quality Assurance

Company: Avanir Pharmaceuticals Inc.
Location: Aliso Viejo
Posted on: September 12, 2020

Job Description:

The Quality Assurance team supports Avanir throughout the product development and commercial life cycle by providing appropriate knowledge/expertise/input and communicating effectively with internal and external stakeholders to ensure that Avanir operates within relevant regulations. This position will be responsible for leading 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. In addition to the primary GCP Quality oversight responsibilities, this role will also support GLP and GVP activities with respect to Quality oversight. Essential Job Functions:

Serve as a subject matter expert to the company on GCP Quality related issues by communicating proactively and effectively with cross-functions at all level.

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.

Oversee and manage the auditing process and other GCP QA inspectional activities

Review supportive clinical trial documents (manuals, study plans) for compliance with regulations.

Implement and maintain SOPs pertaining to Quality of GCP related activities

Actively engaged and participate as part of inspection readiness activities

Coordinate activities and lead interactions during regulatory agency inspections

Adjudicate issues with compliance concerns

Execute and operate within approved operating budget

Support the Company’s project teams and assist with project scheduling to assure that timelines and deadlines are met in the most efficient and economical manner

Travel (domestic and international)

Maintains a performance and improvement culture

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 a life science-related discipline or related field

Advanced degree (PharmD or PhD) preferred

15+ years of experience in the pharmaceutical/ biotechnology industry

Minimum 8 years of experience in GCP Quality roles.

Ability to build and manage relationships with business partners

Strong proven hands-on experience with a variety of GCP compliance matters and contractor management in the bio/pharma industry

Experienced in handling FDA inspections

Proven ability to interpret regulations, to define and communicate strategy/plan to teams across multiple programs

Strong knowledge of US and other major global (ICH, EU, Asian) Clinical regulatory compliance requirements

Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards

Ability to multi-task in a very fast-paced environment

Must be able to effectively collaborate with peers and comfortable working in a matrixed team

Must be solutions oriented and pragmatic (with analytical thinking and problem-solving skills)

Excellent project management and organization skills is a must

Excellent communication skills (verbal and written) and interpersonal 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.

Posted 3 Days Ago

Full time

R2523

About Us Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit http://www.avanir.com

Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en

Avanir® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries

Keywords: Avanir Pharmaceuticals Inc., Aliso Viejo , Director, GCP Quality Assurance, Other , Aliso Viejo, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Amazon Workforce Staffing: Warehouse Team Member - Earn Up To $646 A Week
Description: Warehouse Team
Company: Amazon Workforce Staffing
Location: Rowland Heights
Posted on: 09/23/2020

Amazon Workforce Staffing: Full-Time Seasonal Warehouse Operator - $500 Sign-On Bonus
Description: Earn 15/hr or more, plus benefits and a 500 sign-on bonus. Limited-time opportunity.Shifts: Overnight, Early Morning, Day, Evening, WeekendFull-time jobs available now. Benefits start on your first (more...)
Company: Amazon Workforce Staffing
Location: Yucaipa
Posted on: 09/23/2020

CDL A Company Driver - Home Daily
Description: Hiring Home Daily Company Drivers Our Truck Drivers Enjoy Industry-Leading Benefits: Excellent Pay Based on Experience: Average 1,000- 1,200/week with
Company: Gardner Trucking
Location: Yucaipa
Posted on: 09/23/2020


CDL A Company Driver - No Touch Freight!
Description: Hiring Home Daily Company Drivers Our Truck Drivers Enjoy Industry-Leading Benefits: Excellent Pay Based on Experience: Average 1,000- 1,200/week with
Company: Gardner Trucking
Location: Yucaipa
Posted on: 09/23/2020

CDL A Company Driver - Excellent Company Benefits!
Description: Hiring Home Daily Company Drivers Our Truck Drivers Enjoy Industry-Leading Benefits: Excellent Pay Based on Experience: Average 1,000- 1,200/week with
Company: Gardner Trucking
Location: Yucaipa
Posted on: 09/23/2020

CDL A Company Driver - No Touch Freight!
Description: Hiring Home Daily Company Drivers Our Truck Drivers Enjoy Industry-Leading Benefits: Excellent Pay Based on Experience: Average 1,000- 1,200/week with
Company: Gardner Trucking
Location: San Gabriel
Posted on: 09/23/2020

Amazon Order Picker/Packer
Description: Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Day, Evening, WeekendLocation Chino and EastvaleJob opportunities vary by location. We update postings daily with (more...)
Company: Amazon Workforce Staffing
Location: Rowland Heights
Posted on: 09/23/2020

Amazon Picker/Packer - Part Time
Description: Job Description: 10 10 Amazon remains open as an essential business to serve our communities delivering critical supplies directly to the doorsteps of people who need them Seasonal Warehouse Team Members (more...)
Company: Amazon Workforce Staffing
Location: Yucaipa
Posted on: 09/23/2020

CDL A Company Driver - Home Daily
Description: Hiring Home Daily Company Drivers Our Truck Drivers Enjoy Industry-Leading Benefits: Excellent Pay Based on Experience: Average 1,000- 1,200/week with
Company: Gardner Trucking
Location: San Gabriel
Posted on: 09/23/2020

CDL A Company Driver - Excellent Company Benefits!
Description: Hiring Home Daily Company Drivers Our Truck Drivers Enjoy Industry-Leading Benefits: Excellent Pay Based on Experience: Average 1,000- 1,200/week with
Company: Gardner Trucking
Location: San Gabriel
Posted on: 09/23/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Aliso Viejo RSS job feeds