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Quality Assurance Technician
6 days ago
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Quality Assurance Coordinator
1 week ago
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Quality Assurance Supervisor
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Quality Assurance Specialist
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Quality Assurance Inspector
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Quality Assurance Inspector
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Quality Assurance Investigator
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Quality Assurance Specialist
6 days ago
DPS Group Boston, United StatesADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk assessments and obt ...
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Quality Assurance Specialist
1 week ago
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BlueWave Ventures Plymouth, United StatesTQ stands for Technology in Quality. This is what each of our 2,200 employees stands for. · As one of the largest electronics specialists in Germany, we develop and produce customized and innovative solutions for renowned clients from various industries. In addition, TQ offers re ...
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Quality Assurance Manager
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Quality Assurance Test Manager
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Quality Assurance Analyst I
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Employee Quality Assurance SMT
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Sr Director Quality Assurance
6 days ago
Insmed, Inc. Bridgewater, United StatesCompany Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated ...
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Sr Director Quality Assurance
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BioSpace Bridgewater, United StatesJob Details · Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. W ...
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Quality Assurance Lead III
2 days ago
PSG Global Solutions Bridgewater, United StatesWe're looking for a · Quality Assurance Lead III , working in · Pharmaceuticals · and · Medical Products · industry in · 55 Corporate Drive, Bridgewater, New Jersey, 08807, United States . · Job description: · Develop tools and methods for the North American Quality Busin ...
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Sr Director Quality Assurance
6 days ago
BioSpace Bridgewater, United StatesJob Details · Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. W ...
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VIE - Quality Assurance Coordinator
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EuroAPI Bridgewater, United StatesWe are looking for a VIE - Quality Assurance Coordinator for a VIE contract of 18 months in our US site in Bridgewater to support its activity. · Before applying, please make sure to check the VIE eligibility criteria for the United States and add your resume in English to your ...
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Quality Assurance Technician Imrt
1 week ago
Rhode Island Hospital Providence, United States**Summary**: · Reports to the Associate Physicist in charge of QA and second year Physics Resident. · **Responsibilities**: · Performs clinical patient dosimetry to verify and assure that patient is receiving precisely the prescribed dose. · Measures radiation dose using an array ...
Director, Head of Clinical Quality Assurance - Bridgewater, United States - Gan & Lee Pharmaceuticals Ltd
Description
SummaryThis position reports to the CEO, Gan & Lee Pharmaceuticals. Regular specific interaction also occurs with the President and CEO of Gan & Lee Pharmaceuticals USA. The Clinical Quality Director leads all GxP (GCP mostly) audits/inspections at the US Affiliate.Education and CredentialsCollege degree in a relevant field. Life Sciences Preferred.
ExperienceAt least 10 years in relevant quality auditor roles in which significant exposure to GCP/GLP has occurred.
SkillsDemonstrated ability to lead people in a positive manner.
Demonstrated ability to manage multiple and diverse projects concurrently.
Demonstrated ability to develop positive relationships and collaborations.
Strong analytical skills; a strategic thinker, planner, and implementer.
Reliable, dependable, and consistent worker.
Conscientious and extremely detailed oriented.
Strong ability to create practical and efficient processes.
Highly effective interpersonal skills, in individual as well as in group settings.
Strong communication skills (English), both written and verbal.
Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.
Responsibilities:
Audits:
Prepare individual audit plans and audit/risk mitigation plans for larger projects/programs in support of Gan & Lee Annual Audit Plan.
Plan, conduct, report, and follow-up of internal audits, CRO and site audits, in accordance with current SOP(s).Develop and maintain the GCP audit strategy in collaboration with senior QA leadership.
Perform vendor and clinical site evaluations, as required.Clearly communicate and report (verbally and in writing) audit outcomes to the rest of organization, and escalate quality issues as required.
Support Gan & Lee Inspection Readiness ActivitiesQuality Systems:
Participate in developing, maintaining and improving of the Quality Management System and associated practices.
Participate in inspections performed by FDA and international regulatory agencies; also, audits performed by partners in own area of expertise.
Proactively identify analyses and leverage quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
Deliver input (e.g., GCP, Safety) on relevant projects to the manager and to Quality Management ReviewHandle Deviations, Quality Issues, CAPAs, and changes as required in the clinical studies.
Provide support for SOP Review and DevelopmentTraining:
Provide input for GCP and other relevant training in QA and in the GCP area
Knowledge/Regulation:
Represent QA in study team(s) where relevant and participate as appropriate to ensure clinical trials are conducted in compliance with clinical protocols, GCP and other regulatory requirements.
Provide GCP expertise within the company as well as externally to vendors and service providers as needed.
Provide suggestions for continuous quality improvement in GCP.Maintain expert up-to-date knowledge on GCP legislation and relevant parts of GxP guidelines and practices and ensure that the information is distributed and acknowledged by relevant parts of the Gan & Lee Organization
