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The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing global quality processes** across the organization. This role ensures that product quality systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement** across all regions and product lines.

The Director will lead global initiatives to harmonize and enhance processes related to **product quality complaints, deviations, CAPA, and management reporting** , ensuring timely and effective resolution and robust compliance.

Key Responsibilities

+ Global Process Ownership: Lead the design, implementation, and continuous improvement of global quality processes for:

+ Product Quality Complaints

+ Corrective and Preventive Actions (CAPA)

+ Deviations

+ Management Reporting and Trending

+ Benchmarking & Best Practices: Evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency.

+ GMP Compliance: Ensure all quality processes meet global regulatory requirements (e.g., FDA, EMA, PMDA) and align with current GMP standards.

+ Governance & Standardization: Develop and enforce global standards, SOPs, templates, and tools to ensure consistency across all manufacturing sites and affiliates.

+ Quality Systems Leadership: Oversee the global deployment and optimization of electronic quality systems (e.g., TrackWise), including configuration, training, and validation.

+ Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies.

+ Data-Driven Insights: In collaboration with Quality Operations, lead the development of global quality metrics and dashboards to monitor performance, identify trends, and support decision-making.

+ Team Leadership: Build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence.

Qualifications

Required

Required Qualifications:

+ Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences); advanced degree preferred.

+ Minimum 12 years of experience in pharmaceutical quality assurance or quality systems, with at least 5 years in a global leadership role.

+ Deep understanding of GMP regulations and global regulatory requirements (e.g., 21 CFR Parts 210, 211, 820).

+ Proven experience in managing global quality systems and optimizing complaint, CAPA, and deviation processes.

+ Strong analytical and problem-solving skills with a data-driven mindset.

+ Excellent communication, leadership, and stakeholder management skills.

+ Proficiency in quality management systems (e.g., TrackWise) and Microsoft Office tools.

+ Ability to travel internationally as needed.

Preferred

+ Basic understanding of artificial intelligence and advanced analytics

+ Experience supporting risk management programs or frameworks.

+ Familiarity with quality management systems and digital tools.

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 $183,335.00 - Maximum $274,160.00, 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.