Senior Quality Operations Director
2 weeks ago
The Senior Director Quality Operations is 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.
Key Responsibilities:- Develop and implement QA oversight activities to meet all CGMP regulatory requirements.
- Establish an operational tier structure to ensure continuous compliance with standard operating procedures, processes, and regulatory requirements.
- Lead the Quality Operations team to deliver exceptional performance in each assigned area, including readiness activities before manufacture, oversight during manufacture, and review after manufacture.
- Perform QA review and approval of deviations, CAPAs, and change controls.
- Identify and implement best practices to improve right first time execution.
- Liaise with internal and external stakeholders to achieve expected business outcomes.
- Strong understanding of Quality Systems and cGMP regulations.
- Excellent written and oral communication skills, with the ability to set personal performance goals and provide input to departmental objectives.
- Strong organizational, analytical, data review, and report writing skills.
- Ability to multitask and prioritize work effectively.
- Proficient in Microsoft Excel, Word, and PowerPoint.
- Able to build and maintain effective relationships with key stakeholders.
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Quality Management Senior Director
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeAbout the Role:The Senior Director Quality Operations will play a critical role in 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,...
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Director of Quality Assurance and Compliance
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeAbout 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...
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QA Associate Director Quality Operations
5 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timePosition OverviewSummary: The Associate Director (AD) Quality Operations is responsible for QA oversight of cGMP operations and areas at one of the manufacturing facilities, or the Quality Control unit, at FDBT. This role is expected to lead a value stream such as TBF, FBF, NCTM or Analytical Development under the guidance of the Sr Director Quality...
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Compliance and Quality Operations Manager
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob 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...
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Sr. Director Quality Operations
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timePosition OverviewThe Senior Director Quality Operations is responsible for QA oversight of CGMP manufacturing operations and areas at one of our manufacturing facilities at FDBT. Lead the Quality Operations organization to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external...
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Quality Operations Manager
1 week ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob DescriptionWe are seeking an experienced Associate Director to lead our Quality Operations team at FDBT.About the RoleThis role will oversee QA oversight of cGMP operations and areas, lead a value stream under the guidance of the Sr Director Quality Operations, and ensure products meet all cGMP regulatory requirements.Key ResponsibilitiesDevelop,...
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Manufacturing Quality Director
1 week ago
Hamilton, Waikato, New Zealand Sealed Air Full timeAbout UsAt Sealed Air, we are committed to providing exceptional service to our customers while maintaining the highest levels of quality and efficiency. To achieve this goal, we are seeking a Manufacturing Quality Director to lead our quality improvement efforts and drive process excellence across our manufacturing operations.Job SummaryThe successful...
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Director of Quality Assurance
5 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob Summary:">The Director of Quality Assurance - Clinical and Commercial Operations will be responsible for leading the Quality Assurance team to ensure that all clinical and commercial operations are conducted in accordance with regulatory requirements.Main Responsibilities:">Develop, implement, and maintain QA oversight activities to meet all cGMP...
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Director of Operations Excellence
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeThe Associate Director/Program Director of Project Management Office (PMO) is responsible for leading and managing multiple projects and programs simultaneously. This role requires a high level of strategic thinking and problem-solving skills.Key Responsibilities:Develop and implement project management methodologies and processes to ensure efficient project...
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Director of Strategic Operations
5 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeCompany OverviewFujifilm Diosynth Biotechnologies is a leading provider of pharmaceutical development and manufacturing services. We are committed to delivering high-quality products that meet the needs of our customers.Job DescriptionWe are seeking an Associate Director/Program Director to join our Project Management Office (PMO). The successful candidate...
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Restaurant Operations Director
5 days ago
Hamilton, Waikato, New Zealand Aniruna Limited Full timeWe are seeking a highly skilled Restaurant Operations Director to lead our team at Aniruna Limited.Our company is dedicated to delivering exceptional dining experiences to our guests. As a Restaurant Operations Director, you will play a crucial role in ensuring the smooth operation of our restaurant.Your primary responsibilities will include:* Minimum 2...
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Senior Quality Operations Manager
5 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob Summary:">The Senior Quality Operations Manager is responsible for leading the Quality Operations team to deliver exceptional performance of each assigned area. This includes readiness activities before manufacture, oversight activities during manufacture, and review activities after manufacture.Main Responsibilities:">Develop, implement, and maintain QA...
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Compliance and Quality Director
6 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeQuality 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...
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QA - Director Quality Systems
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timePosition 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: Deviation, CAPA, Change Control, Supplier Quality, Training, Document Control, QA Validation, eQMS, and Quality...
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Qa - Director Quality Compliance
1 week ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timePosition 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...
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Quality Improvement Director
2 days ago
Hamilton, Waikato, New Zealand AUTOBAG® Brand Automated Systems Full timeJob DescriptionWe are seeking a Quality Improvement Director to join our team at AUTOBAG Brand Automated Systems. This is an exciting opportunity for a seasoned professional to drive quality improvement strategies and actions achieving continuous improvement in plant, customer quality and food safety performance.Key Responsibilities:Provide leadership in...
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Quality Control Director
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeAbout the Role:The Director Quality Systems will play a critical role in ensuring the effective development, implementation, and maintenance of Pharmaceutical Quality Systems (PQS) for FDBT. The ideal candidate will have expertise in Pharmaceutical Quality Systems, excellent communication skills, and the ability to lead a team to deliver exceptional...
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Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob SummaryThe Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT. The position involves leading a team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external...
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Director of Quality Systems and Compliance
6 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeAbout 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...
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Director of Quality Assurance
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob 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...