Senior Manager, Quality Assurance GCP
Otsuka Pharmaceutical

Princeton, New Jersey

Posted in Pharmaceuticals


This job has expired.

Job Info


Job Summary

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

  • 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

Education/Qualifications/Certifications (Knowledge, Skills, Abilities, etc.) -
  • 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


Physical Requirements and Work Environment

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.

#MZ1

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:

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.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Valid Proof of COVID-19 Vaccination or Accommodation

The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.


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