Quality Assurance Director Regulatory Compliance

OverviewFujifilm Diosynth Biotechnologies is a dynamic biotechnology company that specializes in the development and manufacture of biopharmaceuticals. We are seeking an experienced Regulatory Compliance and Quality Assurance Expert to join our team. This role will be responsible for ensuring compliance with regulatory requirements and maintaining a high...

Job Summary:OverviewFujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance - Compliance Specialist II - Audit and Inspection to support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.Key ResponsibilitiesWork collaboratively with site...

Quality Compliance LeaderFujifilm Holdings America Corporation is seeking a seasoned professional to serve as our Director of Quality Systems and Compliance. In this critical role, you will be responsible for developing and implementing quality systems and compliance strategies that meet regulatory requirements and support business objectives. If you are a...

Job Summary:The Associate Director (AD) Quality Operations will lead the Quality Operations team to ensure compliance with cGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture. This role requires a strong understanding of quality systems, excellent communication skills, and ability to...

Fujifilm Diosynth Biotechnologies is seeking a Quality Assurance - Compliance Specialist II - Audit and Inspection to support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. This position requires excellent written and oral communication skills, as well as...

Company OverviewFujifilm Holdings America Corporation is a leading provider of innovative medical imaging solutions, and we are committed to advancing the field of medicine through cutting-edge technology and research. Our company prides itself on its mission-driven culture, which fosters a strong sense of community and collaboration among our employees.Job...

Job Description:The Quality Assurance (QA) Operations Supervisor plays a crucial role in ensuring the overall performance of the QA group. The supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance. The role involves supervising direct reports, managing TrackWise...

Job Description:The Director Quality Systems will be responsible for overseeing the development, implementation, and maintenance of Pharmaceutical Quality Systems (PQS) for FDBT. This includes leading a team to create a strong quality culture, ensuring compliance with regulatory requirements, and aligning PQS sub-systems with harmonized global...

About the RoleThe Director of Quality Compliance will play a critical role in ensuring the success of our Pharmaceutical Quality Systems (PQS) program at FUJIFILM Diosynth Biotechnologies. The successful candidate will be responsible for developing and implementing individual sub-systems of the PQS, ensuring compliance with regulatory requirements and...

About the Job:The Senior Director Quality Operations will be responsible for leading the Quality Operations organization to create a strong quality culture, overseeing QA on-the-floor activities, batch record review, and product disposition.Key Accountabilities:Ensure products are manufactured to meet all CGMP regulatory requirements for phase-appropriate...

Job Summary:FUJIFILM Diosynth Biotechnologies is seeking a skilled Quality Assurance (QA) Operations Supervisor to oversee the performance of the QA group. This role will involve handling various responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.Key Responsibilities:Supervise direct reports and...

Company OverviewFujifilm Holdings America Corporation is a leading global manufacturer of innovative products. We are committed to advancing tomorrow's medicine by driving innovation, passion, and excellence in our employees.Job DescriptionThe Director of Quality Compliance will be responsible for developing and implementing individual sub-systems of the...

About UsFujifilm Holdings America Corporation is a leading healthcare and life sciences company that is dedicated to improving lives through innovation. Our commitment to quality and excellence has earned us a reputation as a trusted partner in the industry. We are proud to offer a dynamic and inclusive work environment that fosters growth and development...

About the Role:We are seeking a highly skilled Director of Pharmaceutical Quality Systems to join our team at Fujifilm Diosynth Biotechnologies. The successful candidate will be responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT.Key Responsibilities:Develop and implement...

Job Summary:The Director Quality Systems will lead the development, implementation, and maintenance of Pharmaceutical Quality Systems (PQS) for FDBT. Responsibilities include developing, implementing, and maintaining risk-based PQS sub-systems to meet all CGMP regulatory requirements.Develop, implement, and maintain risk-based PQS sub-systems to meet CGMP...

Job Description:The Senior Director Quality Operations will be responsible for ensuring the site's compliance with CGMP regulatory requirements. This includes leading the Quality Operations organization to create a strong quality culture, overseeing QA on-the-floor activities, batch record review, and product disposition.Responsibilities:Develop and...

Job OverviewThe Quality Assurance-Compliance Specialist II-Audit and Inspection will play a pivotal role in ensuring compliance with FUJIFILM Diosynth Biotechnologies quality policies and site Standard Operating Procedures (SOPs) to maintain regulatory adherence.Key ResponsibilitiesCollaborate with site management to promote a 'Quality Culture' by coaching...

Position OverviewThe Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT.Responsibilities will include one or more PQS sub-systems: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation.Lead the assigned team to...

About the Role:The Associate Director (AD) Quality Operations is responsible for leading the Quality Operations team to ensure compliance with cGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture. This role requires a strong understanding of quality systems, excellent communication...

Job DescriptionThe Quality Assurance Expert III will be responsible for reviewing and approving basic and technical documentation, drafting and reviewing internal quality policies and procedures, performing product-related activities, conducting quality audits, and identifying process improvements.This role involves working under minimal direction to ensure...