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The **Global Quality Audit Manager** is responsible for planning, executing, and reporting on global audits to ensure **Good Clinical Practice (GCP) compliance** across Contract Research Organizations (CROs), clinical laboratories, and clinical investigator sites. This role plays a critical part in maintaining the integrity of clinical trial data and ensuring patient safety by verifying adherence to regulatory requirements and internal standards.

As a key member of the Global Quality Management team, the Audit Manager will collaborate with cross-functional stakeholders to identify risks, drive continuous improvement, and support inspection readiness across the clinical research landscape.

Key Responsibilities

+ **Audit Execution** : Plan, conduct, and report GCP audits of CROs, clinical laboratories, and investigator sites globally, ensuring compliance with ICH-GCP, local regulations, and company policies. Provide oversight to contract and consultant resources in audit conduct and reporting.

+ **Risk-Based Audit Planning** : Support the development and maintenance of a global audit schedule based on risk assessments, regulatory requirements, and business priorities.

+ **Audit Reporting & Follow-Up** : Document audit findings, issue formal reports, and ensure timely follow-up and closure of corrective and preventive actions (CAPAs).

+ **Stakeholder Engagement** : Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and other functions to ensure alignment on quality expectations and audit outcomes.

+ **Continuous Improvement** : Identify trends and systemic issues from audit findings and contribute to the development of global quality improvement initiatives.

+ **Training & Guidance** : Provide GCP compliance training and guidance to internal teams and external partners as needed.

+ **Metrics & Reporting** : Maintain audit metrics and contribute to management reporting on audit outcomes, trends, and compliance risks.

Qualifications

Required

+ Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field; advanced degree preferred.

+ 3 -5 years of experience in clinical quality assurance or GCP auditing within the pharmaceutical, biotech, or CRO industry.

+ In-depth knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements related to clinical research.

+ Experience auditing CROs, investigator sites, and clinical laboratories.

+ Strong analytical, organizational, and communication skills.

+ Ability to work independently and manage multiple audits across global regions.

+ Proficiency in audit management systems and Microsoft Office tools.

+ Willingness to travel internationally up to 20%.

+ **Preferred:**

+ Familiarity with TrackWise or similar quality management systems.

+ Experience working with CROs or external vendors.

+ Exposure to FDA or other health authority inspections.

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 $117,027.00 - Maximum $175,030.00, 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.