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Director of Quality
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GxPeople Global New Hampshire, United StatesDirector of Quality Opportunity in Top Biotechnology Organization · Summary: · Are you a seasoned quality leader seeking an exciting opportunity? Join a top-tier Biotechnology leader in New Hampshire as Director of Quality. Lead their quality organization at the site for C>, lead ...
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Director of Quality Assurance
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Director of Quality Assurance
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Atmospheric G2 Manchester, United StatesJob Title · : Director of Quality Assurance · Location · : Manchester, NH · Company Overview: · For over twenty years, Atmospheric G2 has provided our customers market-leading weather intelligence software that enables them to confidently assess the impacts of weather on thei ...
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Director of Quality Control
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Director of Quality Improvement
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Director, Quality Systems
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Director, Quality Systems
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Director, Quality Systems
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Quality Director II
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Quality Director II
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BAE Systems, plc Nashua, United StatesBAE Systems is seeking a Quality Director in support of our F-35 Solutions Product Line. Reporting to the Sr. Director of Quality in the Electronic Combat Systems Business Area, the selected candidate will lead the teams responsible for quality assur Director, Solutions, Continuo ...
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Director of Quality Improvement
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Director, Quality Systems
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Quality Control Director
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Director of Quality Improvement
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NEEDS Center Andover, United StatesCOME GROW WITH US · The Director of QI (DQI) is responsible for ensuring that all NEEDS Center programs meet and maintain performance standards for licensing and accreditation and requirements as outlined in DDS contracts. This position requires the employee to be highly detailed ...
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Director of Quality Improvement
2 days ago
NEEDS Center Andover, United StatesCOME GROW WITH US · The Director of QI (DQI) is responsible for ensuring that all NEEDS Center programs meet and maintain performance standards for licensing and accreditation and requirements as outlined in DDS contracts. This position requires the employee to be highly detailed ...
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Sarepta Therapeutics Andover, United States Full timeThe Executive Director QC leads a high-functioning QC group comprising 35-40 individuals and 3 direct reports. The ideal candidate should be highly skilled in managing external manufacturing and testing sites both in the USA and across the world. The successful candidate will fos ...
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LPN Licensed Practical Nurse
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Director of Care Coordination
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TC04 - Nurse
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Director of Quality - Manchester, United States - GxPeople Global
Description
Director of Quality Opportunity in Top Biotechnology OrganizationSummary:
Are you a seasoned quality leader seeking an exciting opportunity? Join a top-tier Biotechnology leader in New Hampshire as Director of Quality.
Lead their quality organization at the site for C>, lead and support Audits and Regulatory Inspections at the site, and lead, develop and direct staff in both QA and QC.
ResponsbilitiesProvide strategic leadership and management for the asset Quality organization.
Ensure teamwork, high morale, and innovation are fundamental components of the team.
Develop and execute the Quality strategy aligned with the overall plan for the company.
Implement continuous improvement initiatives to drive Quality programs.
Develop, implement, and monitor Quality programs, policies, and procedures to ensure compliance with GMP standards.
Serve as the point person with industry partners regarding product quality matters.
Oversee all partner and regulatory authority audits and inspections.
Evaluate and recommend appropriate enhancements to current Quality systems and processes.
Create active training and development plans for Quality staff.
Establish and maintain positive working relationships with customers, FDA, and other regulatory authorities.
Provide solid, well-informed, actionable Quality support to Operations, R&T, and other functions.
Be a member of the Site Leadership team.
Requirements:
Bachelor's Degree in Life Sciences, Engineering, or Quality Management or related discipline.
10+ years of direct professional experience in GMP manufacturing and Quality Management.
At least 7 years in senior leadership positions.
Experience in aseptic processing
Expert knowledge of GxP, ISO Standards, FDA, and EMA regulatory requirements related to Cell/Gene/Viral therapy products
Strong knowledge of current industry trends and technologies.
Working knowledge of aseptic practices, clean room design/operations, and auditing techniques.
Excellent organizational and computer software skills.
This role is only available for US Citizens or green card holders
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