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Quality Manager, Global Quality Management

Description of Role

The main purpose of this role is to support the Global Quality Management team with an emphasis on GxP audit coordination. In addition to these activities, the role would include supporting the Global Quality Management team with inspection readiness/ management activities, and other QA activities as required.

Key Responsibilities and Decision

In close collaboration with the Director, Global Quality Audit Management:

Audit Related Activities

+ Coordinate, support, and manage GxP Audit activities

Organize audit preparation meetings

Track Audit scheduling and keep Master Audit Schedule tracker up-to-date

+ Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees

+ Assist the audit programme with planning, communicating, documenting, and executing the GxP audit strategy

+ Support the Global Quality Management team in risk assessment activities

+ Support the preparation and review of Audit Reports

Otsuka Companies’ Quality System

+ Support the continuous improvement and enhancement of the Quality System (e.g., Trackwise, ACE, etc.)

+ Collaborate with the respective Functional Areas representatives as required for audits

+ Foster a continuous improvement mentality within Otsuka

+ Support the establishment and maintenance of the required Audit/Inspection Documentation

+ Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution

Regulatory Inspections

+ Support the preparation for inspections

+ Support the Global Quality Management teams with the responses to Regulatory Authorities

+ Support the review and assessment of corrective and preventive actions (CAPA)

+ Manage ACE Chat, Scribe Notes and other assigned activities

JOB SCOPE (key facts)

+ Located in Princeton, NJ or Rockville, MD

+ The employee will report to Director, Audit Program Management, Global Quality Management

+ The employee should be able to travel domestically and/or internationally at short notice as needed for supporting inspections/audits.

QUALIFICATIONS/ EXPERIENCE

+ BS degree in the sciences

+ 2 or more years in multi-national biopharmaceutical industry that includes performing GxP audits, or clinical monitoring or inspection readiness activities

+ Experience in CAPA management

+ Exposure to regulatory inspections

COMPETENCIES

+ Knowledge of regulations and guidance regarding clinical development

+ Understanding of Good Clinical Practice processes

+ Understanding of audits and CAPA management

+ Ability to work independently and as part of a quality team supporting the lifecycle of audits

+ Well versed with MS Office (advance users in Excel & PowerPoint preferred). Knowledge of TrackWise, ACE, Veeva desirable

+ Excellent communication skills (written and oral) in English

+ Problem solving and resolution skills

+ Analytical and creative thinking

+ Understanding of being risk based focused and prioritizing work based on Risk Management methodologies

Competencies

**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.

**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

**Respectful Collaboration -** Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

**Empowered Development -** Play an active role in professional development as a business imperative.

Minimum $107,718.00 - Maximum $161,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

**Application Deadline** : This will be posted for a minimum of 5 business days.

**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ([email protected]) .

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.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.