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Otsuka Pharmaceutical Companies (U.S.) · 1 day ago

Director, Global Quality GMP Processes

United States

Full-time

Remote

Director/Executive

$183K/yr - $274K/yr

12+ years exp

Otsuka Pharmaceutical Companies (U.S.) is seeking a Director, Global Product Quality, GMP Processes to lead strategic initiatives in global quality management. This role focuses on optimizing quality processes in alignment with Good Manufacturing Practices and regulatory requirements, while fostering a culture of continuous improvement across the organization.

Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

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

Qualification

GMP regulationsQuality management systemsData-driven mindsetAnalytical skillsTrackWiseStakeholder managementMicrosoft OfficeRisk managementArtificial intelligenceLeadership skills

Required

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

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

Paid leave programs

Other company provided benefits

Company

Otsuka Pharmaceutical Companies (U.S.)

Glassdoor4.1

There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.

Founded in 1989

Rockville, Maryland, USA

1001-5000 employees

https://www.otsuka-us.com

H1B Sponsorship

Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (8)

2024 (6)

2023 (11)

2022 (5)

2021 (9)

2020 (13)