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Director of Quality
1 week ago
Siemens Corporation Raleigh, United StatesJoin us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. · Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibi ...
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Director of Quality
1 week ago
Siemens Raleigh, United StatesJoin us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. · Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibi ...
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Director of Quality
2 weeks ago
EPM Scientific Raleigh, United StatesDirector of Quality – Med Device · Location : Raleigh, NC · Working situation : Hybrid · Level : Director · Our client, a mid-sized medical device company producing Class II & Class III devices, is looking to add to their Quality team · The · Director – Quality Assurance · w ...
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Istituto Marangoni Raleigh, United StatesThe Global Associate Director/Director, Quality Assurance, is responsible for the global strategic management and oversight of R&D Quality activities and associated staff related to Good Manufacturing Practices (GMP) for non-Energy Based Devices (EBD) and EBD Medical Devices. Act ...
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Director, Quality Management
2 weeks ago
ECU Health Raleigh, United StatesECU Health · About ECU Health North Hospital · ECU Health North Hospital is a Joint Commission-accredited, 204-bed acute bed facility serving Halifax, Northampton and Warren counties in the north-central region of North Carolina. Its service area also reaches into southern Virgin ...
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Director, Quality Performance
3 weeks ago
Kimmel & Associates Wake County, NC, United StatesA full-service $ 70 million specialty trade subcontractor offering services in mechanical, electrical, structural, and hygienic piping trades. The company has been around for over 30 years and focuses on pharmaceutical, food/beverage, and chemical facility construction. Large, tr ...
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Director of Quality/Patient Safety
2 weeks ago
LifePoint Health Raleigh, United StatesJob Description - Director of Quality/Patient Safety · Job Description · Director of Quality/Patient Safety · - · Description · Develops and implements departmental goals, plans, and standards consistent with the clinical, · administrative, legal, and ethical requirements/obje ...
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Director, Global Quality
1 week ago
Loparex LLC Cary, United StatesJob Description · Job DescriptionThe Director, Global Quality is responsible for providing leadership and direction for Loparex's quality function. The Director will drive continuous improvement of Loparex's quality performance by (non-exhaustive list): defining and implementing ...
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Director of Quality
2 weeks ago
RR Donnelley Durham, United StatesJob Description · Job DescriptionCompany Description · RRD is a leading global provider of marketing, packaging, print, and supply chain solutions that elevate engagement across the complete customer journey. The company offers the industry's most trusted portfolio of creative ex ...
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Director of Quality Control
6 days ago
Kinetics Durham, United StatesFounded in 1973, Kinetics is a global full-service process and mechanical contractor specializing in the design and installation of process, mechanical, plumbing and HVAC systems. We have proven experience supporting global clients in the microelectronic, solar, biopharmaceutical ...
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Sr Director Digital System Quality Assurance
1 week ago
Thermo Fisher Scientific Raleigh, United StatesWork Schedule · Other · Environmental Conditions · Office · Job Description · Job Description: Senior Director, Quality · Job Title: Senior Director of Digital System Quality Assurance, Global Quality Systems, Pharma Services Group · When you're part of the team at Thermo Fishe ...
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Director, Global Quality
1 week ago
Loparex Cary, United StatesThe Director, Global Quality is responsible for providing leadership and direction for Loparex's quality function. The Director will drive continuous improvement of Loparex's quality performance by (non-exhaustive list): defining and implementing suitable performance metrics, ass ...
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Director of Quality
4 weeks ago
R.R. Donnelley Durham, United StatesCandidates in Durham, NC; Chicago, IL; Milwaukee, WI; Greensboro, NC; Westchester, OH; Seattle, WA are highly preferred. This is a Platform Wide position responsible for facilitating & coordinating the Quality Management System (QMS) and Operational Operations, Director, Continuo ...
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Associate Director, Quality Control
1 hour ago
Fujifilm Holdings Corp Durham, United StatesMain areas of responsibility include, but are not limited to:Creates a safe working environment within QC through a culture of behavioral safety and adherence to site EHS policies and procedures. Ensures team are actively engaged in the on-time deliv Quality Control, Microbiology ...
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Associate Director, Quality Control
22 hours ago
FUJIFILM Corporation Durham, United StatesOverview: · The Associate Director, Quality Control (Microbiology) is responsible for the effective management of the Quality Control Microbiology team to assure on time analysis of manufactured product and environmental monitoring samples. Responsible to assure all testing is p ...
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Senior Director Software Quality
1 week ago
GRAIL, Inc. Durham, United StatesGRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power o ...
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Associate Director, Quality Management
22 hours ago
IQVIA Durham, United StatesJob Overview: · This role is assigned to designated Delivery Unit(s), country/countries, sponsor(s), business units(s), and/or specific tasks as defined by the line manager (LM). Contributes to the development and is responsible for the implementation of specific quality improve ...
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Associate Director, Quality Assurance
1 hour ago
Biogen Durham, United StatesJob Description · About This Role · This critical position provides QA operational leadership for the RTP Drug Substance Manufacturing site in RTP, specifically in the areas of Small Scale Manufacturing (SSM), Flexible Volume Manufacturing (FVM), and Cell Banking. You will be re ...
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Associate Director, Quality Assurance
4 days ago
Biogen Durham, United StatesJob Description · About This Role · This critical position provides QA operational leadership for the RTP Drug Substance Manufacturing site in RTP, specifically in the areas of Small Scale Manufacturing (SSM), Flexible Volume Manufacturing (FVM), and Cell Banking. You will be res ...
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Associate Director, Quality Management
22 hours ago
Iqvia Argentina Durham, United StatesJob Overview: · This role is assigned to designated Delivery Unit(s), country/countries, sponsor(s), business units(s), and/or specific tasks as defined by the line manager (LM). Contributes to the development and is responsible for the implementation of specific quality improvem ...
Traveling Director of Quality - Raleigh, NC, United States - Jobot
Description
Bonus + Equity + 401(k) + Benefits +REMOTE
We are a rapidly growing therapeutics company with an approved drug on the market, leveraging scientific advances in B-cell biology to develop novel treatment for patients.
REMOTE
Commercial drug
The Associate Director/Director, Quality Systems plays a key role in overseeing all aspects of the quality management system (QMS), including the development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements and industry standards (cGMP).
The successful candidate will have experience implementing, maintaining, and optimizing Veeva (including system configuration) within a smaller biotechnology company supporting a commercial drug product and clinical pipeline.
This position will report to the VP of Quality Systems.Design, develop, configure, implement, maintain, and continuously improve Veeva (Quality and RIM Vaults) to ensure compliance with regulatory requirements (e.g., cGMP), and company policies.
Work with system users to provide analysis, solve issues, and provide training / mentoring and drive improvementsSOPs, policies, work instructions, etc.) to ensure compliance with regulatory requirements.
Collaborate with cross-functional teams to ensure alignment on quality objectives, initiatives, and priorities.
Develop and implement quality metrics, key performance indicators (KPIs), and dashboards to monitor the QMS's performance and drive continuous improvement.
Periodically report quality metrics to key stakeholders in the company.In collaboration with Quality Leads, ensure the timely investigation and resolution of deviations, non-conformities, and customer complaints related to product quality, safety, or efficacy.
Provide leadership, mentorship, and coaching to the quality system team, fostering a culture of quality excellence, accountability, and continuous learning.
Serve as a subject matter expert on the Quality Management System during regulatory inspections, customer audits, and internal reviews, ensuring successful outcomes and compliance with requirements.
Travel 10-15% of time for meetings, audits, and inspections.University degree in life sciences or related field. Post-Graduate work is preferred.
Minimum of 8+ years in Quality Systems/Quality Assurance/Quality Control in biopharma/biologics/pharmaceutical industry
Demonstrated experience with implementing, optimizing, and maintaining QMS Software, specifically Veeva Quality. Thorough knowledge of GxP (GMP, GLP, GCP, GVP) and Computer System Compliance regulations
Demonstrated ability to broadly assess regulatory compliance audit findings and implement appropriate CAPA
Technically proficient on system configuration, as you will serve as the technical expert on the system.
Traveling Director of Quality professionals in Raleigh
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Stephanie Ladd
Senior Clinical Research Professional