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Quality Management System
3 weeks ago
Express Employment Professionals Bellingham, WA New York, United StatesWe are hiring for an exciting opportuinty Do you have experience in the medical device industry? We want to talk to you This position offers great compensation and benfits · Qualifications · •A four-year degree in engineering, law, medicine, pharmacy, or another relevant scienti ...
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Quality System Manager
3 weeks ago
Adecco Permanent Recruitment New York, United StatesEssential Functions · Ensure compliance to Regulatory, Customer, and quality systems requirements. · Direct all activities of Laboratory Managers and Quality Department personnel. · Act as primary quality contact with new and existing customers to ensure products are manufactured ...
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Director of Quality Systems
3 weeks ago
Page Mechanical Group Inc New York, United StatesJOB TITLE: Director Quality Systems · DATE PREPARED: March 4, 2024 · JOB SUMMARY: · This position will drive the design and implementation of fit-for-purpose, phase appropriate Quality Systems. The Director of Quality Systems will establish the framework and provide strategic ...
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Quality System Manager
1 week ago
Filtration Group New York, United StatesFlow Dry Technology is a leading manufacturer of automotive desiccant components, which are critical to vehicle functionality and safety. We historically have focused on desiccant components for HVAC systems, winning the trust of discerning Tier 1 Automotive suppliers and OEMs. I ...
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Quality Systems Coordinator
1 week ago
GEA York, United States Full timeResponsibilities / Tasks · The Product Quality Systems Coordinator (PQSC) will facilitate a weekly Product Quality Review Board (PQRB) meeting of all escalated SQDIPE/Warranty/NCR action items, while also reviewing potential ECN proposals. · Responsibilities / Expectations: · As ...
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Quality Systems Engineer
2 weeks ago
Dupont Newark, United States OTHEREn DuPont, trabajamos en cosas que importan, ya sea en proporcionar agua limpia a más de mil millones de personas en el planeta, producir materiales esenciales en los dispositivos tecnológicos cotidianos (desde smartphones hasta vehículos eléctricos) o proteger a los trabajadores ...
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System Quality Test Technician
3 weeks ago
Standard Bots Glen Cove, United States**Company Overview**: · Standard Bots is a cutting-edge robotics startup dedicated to revolutionizing the robotics industry. Gone are the days of hard-to-set-up robots, complex third-party integrations, horrible UI, etc. If you are interested in robotics testing and want to join ...
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Quality Management Systems Engineer
1 week ago
LHH New Jersey, United StatesResponsibilities: · Assure that the Quality Management System is kept current and that all Quality Requirements are complied with. · Predict, identify and prevent quality defects and address and resolve product customer quality problems · Support both internal and external custom ...
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Food Quality Systems Lead
3 weeks ago
Kerry New York, United StatesAbout Kerry · Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Ou ...
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Senior Quality Systems Manager
2 weeks ago
ACE Partners New York, United StatesOur client, a well-established Medical Device manufacturer are looking for a · Senior Manager, Quality Systems , to join the team in Arizona. This is a on-site role and you need to be based locally. · Responsibilities: · Drive Quality strategic plans for our Scottsdale site. · ...
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Director, Quality Systems, QA
2 weeks ago
Formation Bio New York, United StatesAbout Formation Bio · At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently. · At Formation Bio we license clinical ...
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Director, Quality Systems, QA
2 weeks ago
Formation Bio New York, United StatesAbout Formation BioAt Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.At Formation Bio we license clinical stage dr ...
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Senior Manager, Quality Systems
1 week ago
Glossier Inc New York, United StatesOverview · We are a people-powered beauty ecosystem, leveraging unique and engaging online and offline experiences as well as consumer participation to fuel our growth. In 9 years, we have built an iconic brand that has revolutionized how consumers, and how the industry, think o ...
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SPECTRAFORCE Newark, United StatesJob Title : Specialist Quality Systems and Compliance IV · Location : Newark, CA · Duration : 6 months · Pay Range: $75/hr-$80/hr on W2 · Job Description: · In support of Client's Quality Systems and Compliance initiatives, Service Provider shall perform the Services identified ...
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Quality Management Systems QMS Engineer
6 days ago
Toyo Tires New York, United StatesReady to champion quality excellence? Join us as a Quality Management System (QMS) Engineer You'll lead the implementation and maintenance of quality standards throughout production, coordinate activities, manage documentation, and drive continuous improvement. Your expertise wil ...
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Thermo Fisher Scientific New York, United StatesLead and implement a strategic plan for global digital Quality Assurance systems. Provide leadership for data analysis, AI, metrics, and real-time reporting for overall quality performance. Direct teams to provide Quality Assurance oversight for digi.. ...
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Quality Systems Analytics Specialist, Onsite
2 weeks ago
AbbVie Jersey City, United StatesJob Description · We are looking for a skilledQuality Systems Analytics Specialist to join our team at the Branchburg site. This position offers a unique opportunity to lead and develop a data-driven culture within our quality organization and site, reporting directly to the Exec ...
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Quality Systems Analytics Specialist, Onsite
2 weeks ago
AbbVie Jersey City, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic area ...
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Quality Systems Analytics Specialist, Onsite
1 week ago
AbbVie Jersey City, United StatesJob Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...
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IT Manager, Quality Systems
3 weeks ago
Catalent Inc Hillside, United StatesIT Manager, Quality Systems · Position Summary: · Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential ...
Director, Quality Systems, QA - New York, United States - Formation Bio
Description
About Formation BioAt Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.
Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%.
This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs.
Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases.
Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.About the PositionThe Director, Quality Systems plays a pivotal role in ensuring quality, safety, and efficacy of pharmaceutical products through the establishment and continuous improvement of an effective and compliant quality management system (QMS) ensuring Formation Bio is in an inspection ready state.
This role is responsible for overseeing all aspects of the quality system, including the development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements, industry standards, and best practices in pharmaceutical manufacturing and defending it during health authority audits.
ResponsibilitiesDevelop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (e.g., FDA, EMA), industry standards (e.g., cGMP), and company policies.
Establish and maintain quality assurance procedures, processes, and documentation to ensure the consistent production of safe, effective, and high-quality pharmaceutical products.
Lead internal and external audits to assess compliance with regulatory requirements, identify areas for improvement, and implement corrective and preventive actions (CAPAs) as needed.
Collaborate with cross-functional teams (e.g., Engineering, Tech, R&D, Manufacturing, Regulatory Affairs) 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.
In collaboration with GXP Quality Leads, ensure the timely investigation and resolution of deviations, non-conformities, and customer complaints related to product quality, safety, or efficacy.
Stay abreast of changes in regulations, guidelines, and industry trends related to pharmaceutical quality assurance and proactively implement necessary updates to the QMS.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 quality assurance matters during regulatory inspections, customer audits, and internal reviews, ensuring successful outcomes and compliance with requirements.
About YouStrategic thinker, strong leader, and subject matter expert in pharmaceutical quality systems with the ability to design and implement a 'fit for purpose' Quality Management System and a passion for driving a quality mindset across the organization.
Bachelor's degree in pharmacy, pharmaceutical sciences, chemistry, or a related scientific discipline. Advanced degree (e.g., Master's or PhD) is preferred.Extensive experience (+12 years) in quality assurance roles within the pharmaceutical industry, with a strong understanding of cGMP regulations, quality systems, and pharmaceutical manufacturing processes.
Proven track record of building and managing a high performing team of professionalsIn-depth knowledge of regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines.
Proven experience in developing, implementing, and managing pharmaceutical quality management systems, including document control, training management, change control, corrective action preventative action, and deviation management processes.
Strong leadership and communication skills, with the ability to effectively collaborate, influence and educate stakeholders at all levels of the organization.
Experience leading regulatory inspections (e.g., FDA inspections, MHRA inspections, EMA inspections, etc. ) and customer audits, with a track record of successful outcomes.Demonstrated ability to analyze data, identify trends, and implement proactive measures to mitigate risks and improve quality performance.
Excellent problem-solving skills, with the ability to lead root cause analysis investigations and implement corrective and preventive actions (CAPAs) effectively.
Proficiency in quality management tools and methodologies (e.g., risk assessment, root cause analysis, FMEA) and quality management software systems.Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects concurrently in a fast-paced environment.
We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission.
We pay all employees competitively relative to the New York City market, regardless of their location.In compliance with NYC's pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio.
The target salary range for this role is $190,000 - $240,000.On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits - learn more about them and our compensation philosophy here.
If this range doesn't match your expectations, please still apply because we may have something else for you.You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.