| Job alert | Jobs 41 - 50 of 973 |
Senior Quality Assurance Manager
Planet Pharma
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Waltham, MA
... • Provide interpretation and guidance for internal and external customers on GCP related regulations/ guidelines (FDA, ICH, EU, etc.), including Risk Based Quality Management, and company procedures and policies. • Collaborate with internal and ... - May 23
Global Regulatory Strategy Director
Aquinas Consulting
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Boston, MA
... Representing company as point contact FDA and leading company delegation for regulatory authority meetings. Leading US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, ... - Jun 11
Senior Statistical Programmer
Sarepta Therapeutics
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Cambridge, MA
... • Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements. • Familiarity with FDA and ICH regulations and guidelines. • Excellent problem-solving skills. • Good written and verbal communication skills and ... - Jun 14
Quality Assurance Manager
Veritas Search Group
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Boston, MA, 02298
... - Oversee change controls, complaints, investigations, CAPAs, IQ/OQ/PQ protocols and reports, specifications, and stability protocols to ensure compliance with regulatory requirements (FDA/ICH/ISO). - Review and approve lot analytical methods, ... - May 19
Chief Technical Officer (Small Molecule)
Kennedy Bond
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Boston, MA, 02298
... Ensure quality oversight for FDA readiness, oversee tech transfer, batch record review, validation, comparability studies, fill finish, change control, etc.; Ensure timely delivery of drug substance and drug product for discovery initiatives; ... - May 23
Senior Quality Engineer
Global Life Science Hub
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Lexington, MA
... At least 3 years of relevant experience in Quality Management within an FDA-regulated environment, ideally in the medical device or in vitro diagnostics industry. ASQ or Six Sigma Certification or equivalent is preferred. Strong knowledge of FDA ... - Jun 07
Sr. Manager GCP quality Assurance
Planet Pharma
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Waltham, MA
... • Provide interpretation and guidance for internal and external customers on GCP related regulations/ guidelines (FDA, ICH, EU, etc.), including Risk Based Quality Management, and company procedures and policies. • Collaborate with internal and ... - May 19
HVAC Technician
Mentor Technical Group
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Boston, MA
Job Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and ... - Jun 16
Project Manage(onsite)
SmartIPlace
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Boston, MA
... Representing Alexion as point contact FDA and leading Alexion delegation for regulatory authority meetings. Leading US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, ... - Jun 11
Vice President Regulatory Affairs Quality Assurance
EPM Scientific
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Boston, MA, 02298
... Relationship Management: Cultivate strong relationships with regulatory authorities, including the FDA, EMA, and other global health authorities, serving as the primary liaison for regulatory interactions and communications. Quality Assurance ... - Jun 02