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Daiichi Sankyo Trenton, United StatesAssociate Director, Global Strategy and Operations (Global R&D PV QA) · in · Basking Ridge · at · Daiichi Sankyo · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to imp ...
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Daiichi Sankyo Company, Limited Trenton, United StatesAssociate Director, Global Strategy and Operations (Global R&D PV QA) page is loaded · Associate Director, Global Strategy and Operations (Global R&D PV QA) · Apply · remote type · Hybrid Work Arrangement · locations · Basking Ridge, NJ · time type · Full time · posted o ...
Global Quality VP - Trenton, United States - A Global CGT CDMO Company
Description
Responsibilities:
Leadership :
Provide strategic leadership to the Quality organization, fostering a culture of quality excellence and continuous improvement.
Quality Systems :
Develop, implement, and maintain robust quality systems and processes to ensure compliance with cGMP, FDA, EMA, and other regulatory requirements.
Regulatory Compliance :
Stay abreast of evolving regulatory requirements and ensure that quality systems and processes are updated accordingly.
Quality Assurance :
Oversee the Quality Assurance function, including batch release, product disposition, deviation management, change control, and CAPA.
Quality Control :
Oversee the Quality Control function, ensuring timely and accurate testing of raw materials, intermediates, and finished products.
Supplier Quality Management :
Establish and maintain supplier quality management processes to ensure the quality and reliability of raw materials and components.
Audits and Inspections :
Manage regulatory inspections and internal/external audits, ensuring readiness and timely response to audit findings.
Quality Metrics and Reporting :
Define and track key quality metrics to measure performance and drive continuous improvement.
Training and Development :
Develop and implement quality training programs to ensure that employees understand their roles and responsibilities in maintaining quality standards.
Quality Culture :
Promote a culture of quality throughout the organization, emphasizing the importance of quality in all activities and decision-making processes.
Qualifications:
Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with at least 10 years in Quality leadership roles.
In-depth knowledge of cGMP regulations and international regulatory requirements for biologics and cell and gene therapies.Proven track record of successfully leading global Quality organizations and implementing quality systems and processes.
Strong leadership and management skills, with the ability to inspire and motivate teams to achieve excellence.
Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
Strategic thinker with the ability to develop and execute quality strategies aligned with business objectives.
Experience managing regulatory inspections and audits, with a strong understanding of regulatory expectations and requirements.
Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.
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