167 applicants
Daiichi Sankyo, Inc. · 6 days ago
Director, Global Quality Assurance, GMP Compliance
United States
Full-time
Hybrid
Director
10+ years exp
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Responsibilities
Responsible for leading inspection readiness activities, including mock inspections and on-site support during regulatory inspections.
Evaluates GMP readiness of global supply chain, ensuring regulatory compliance for local and global markets.
Leads Global GMP Compliance team's participation in project teams and provides consultation services.
Contributes to achieving global QA vision and enhancing globalization at DS QA-GMP affiliates.
Collaborates with various teams to ensure GMP compliance and quality improvement initiatives at Global External Suppliers.
Develops staff to maintain a mature GMP and Quality Culture and ensures compliance with cGMP regulations.
Creates an innovative and quality-driven environment, drives employee engagement and performance management.
Leads remediation and risk management, maintains project management methodologies, and supports global GMP quality objectives.
Qualification
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Required
Bachelor's Degree required
10 or more years professional experience at a management level, leading a QA organization or regulatory authority and demonstrated track record of successful results required
7 or more years of professional experience managing many aspects of quality in an international, global context in a regulated healthcare environment required
Must have experience working within Bio, Pharma, Medical Device, Vaccines, Diagnostics, Combinations Products, including experience in sterile operations, antibody manufacturing
Proven expertise in continuous improvement, change management, and evolving the capabilities of an organization required
Demonstrated experience working directly with global Health Authorities (FDA, EMA, MHRA) and other government and local agencies required
Must have strong working knowledge of the end-to-end manufacturing process required
Must have solid understanding of quality management and continuous process improvement principles including global cGMP requirements required
Preferred
Master's Degree preferred
Physical Requirements: standing and walking for long periods of time, ability to climb stairs, and perform gowning in laboratory and manufacturing sites
Travel: Must have ability to travel up to 50% including overnight and international travel
Company
Daiichi Sankyo, Inc.
At Daiichi Sankyo, we create essential medicine for longer, better lives.
10,001+ employees
H1B Sponsorship
Daiichi Sankyo, Inc. 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
Trends of Total Sponsorships
2023 (14)
2022 (13)
2021 (7)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Ken Keller
Chairman of the Board, President and CEO and Head of the Global Oncology Business Unit
Christopher Geloso
Senior Region Business Director - ADC Oncology at Daiichi Sankyo, Inc.
Recent News
Endpoints News
2024-05-29
2024-05-28
Google Patent
2024-04-13
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