- Oversees day to day Quality Operations activities at the site as required to support Operations including Raw Material & Component Release, Maintenance of the Site Master Validation Plan, Quality Engineering with oversight for Root Cause Investigation, Product Disposition, Corrective & Preventative Action.
- Collaborate with other members of the Global Quality & Compliance organization and will lead teams on the identification and standardization of best practices to drive both compliance excellence and process efficiency.
- Drives implementation plan of controlled document management, review and approve various GxP documentation, including master batch records, specifications,
- Responsible for incoming raw material management, including receiving, inspection, storage, issuance.
- Oversee the storage, distribution, and management of Galaxy laboratory reagents and consumables related to the Clinical trial operation ensuring supplies are readily available for the lab when needed.
- Monitor inventory levels and collaborate with the procurement, R & D leadership team on forecasts to ensure sufficient stock while minimizing excess inventory and associated costs.
- Implement inventory control measures to prevent stockouts and overstock situations.
- Manage the organization and layout of the warehouse to maximize space utilization and ease of access, yet maintained in compliance with FDA, ISO, and CAP/CLIA regulations and safety standards.
- Collaborates with Operations and procurement leaders to identify potential areas of process and product variability, addresses root causes and implements improvements through the CAPA process to ensure the flow of quality products through the supply chain.
- Implement policies and procedures to maintain an effective equipment program including procurement in collaboration with Biomedical Engineering function.
- Manage and direct effective maintenance and calibration programs, equipment safety programs, and equipment utilization.
- Ensures company preventive maintenance programs are in place for all equipment.
- Directs activities to ensure that the site is in a continued state of compliance and inspection readiness including analysis and evaluation of data and presentation to senior management to ensure that resources are sufficient, and projects are appropriately prioritized in alignment with regulatory requirements and business goals.
- Utilizes data to assess the overall health and effectiveness of the Quality Operations processes / systems and identification of areas for process improvement.
- Leads strategy development at the site level and supports at the global level execution of a pipeline of continuous improvement initiatives to drive simplification, reliability, and overall effectiveness of Quality processes.
- A minimum of 8-10 years' experience in the Pharmaceutical, Medical Device or Biotech Industry with a strong preference for leadership experience in a functional Quality role.
- Experience in project management and continuous improvement methodologies (e.g. Six Sigma, Lean, Total Quality Management) preferred.
- Broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, GMP Operations as well as a good working knowledge of related functions such as operations, supplier management, laboratory operations and product development.
- Working knowledge of FDA 21CFR Part 820 Quality Systems Regulations, ISO13485 standards, and CLIA, CAP, FDA requirements
- Demonstrated knowledge of business impact of compliance issues and risk management.
- Strong working relationships with Operations, Procurement, R&D, Regulatory Affairs, and the broader Global Quality & Compliance organization are necessary to drive effective prioritization and collaboration to meet the needs of the business.
- Possesses strong conflict resolution, change management, communication (written and verbal), organizational management, business ethics and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional environment.
- Ability to host / manage external Quality System inspections is required with a preference for experience gained with hosting FDA and other health authority inspections.
- Highly collaborative and leads by example with a servant leadership model.
- Ability and willingness to roll up sleeves and engage to resolve day-to-day issues.
- Bachelor's degree is required
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Director, Quality Operations
3 weeks ago
Quest Diagnostics Lewisville, United StatesOverview: · The Director, Quality Operations will be responsible to lead site-level Quality Control & Quality Assurance function activities, the Quality Management Systems (QMS), assure compliance to USA FDA GXP regulations across IVD products and all regulatory audit and inspec ...
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Dir, Quality Operations
4 weeks ago
Quest Diagnostics Lewisville, United StatesOverview · The Director, Quality Operations will be responsible to lead site-level Quality Control & Quality Assurance function activities, the Quality Management Systems (QMS), assure compliance to USA FDA GXP regulations across IVD products and all regulatory audit and inspect ...
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pw- water quality operator
3 weeks ago
City of Coppell TX Coppell, United StatesTo ensure you receive email communications from us, please add and to your address book. The Opportunity The City of Coppell Public Works (Operations- Water Quality) Department seeks to bring Operator, Water, Commercial Driver, Manufacturing, Application ...
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Quality Control Operator
2 weeks ago
Barcel USA Coppell, United StatesJob DetailsLevelEntryJob LocationBLU Coppell Plant - Coppell, TXPosition TypeFull TimeEducation LevelHigh SchoolTravel PercentageNoneJob ShiftAnyJob CategoryManufacturingDescriptionJob Details:The Quality Control Operator ensures the products meet their respective specifications ...
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Quality Assurance Manager- Operations
3 weeks ago
Insight Enterprises Fort Worth, United StatesRequisition Number: 96819 · Manager, Quality Assurance · Insight Enterprises is a Fortune 500 Solutions Integrator helping organizations accelerate transformation by unlocking the power of people and technology. With a 35-year foundation in hardware and software supply chain aug ...
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pw- water quality operator
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City of Coppell, TX Coppell, United StatesSalary: $ $23.53 Hourly · Location : City of Coppell Town Center, TX · Job Type: Full Time · Department: UTILITY OPERATIONS · Opening Date: 02/22/2024 · Closing Date: Continuous · To ensure you receive email communications from us, please add and to your address book. · T ...
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National Customer Service Technician
1 week ago
FusionWorks Lewisville, United StatesWe are currently seeking a National Customer Service Technician (m/f/d) for a renowned company in Zarrentin am Schaalsee. · Your responsibilities as a National Customer Service Technician (m/f/d) include: · Providing timely and high-quality customer support · Building long-term p ...
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Salesperson/Cashier (male/female/diverse)
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NebulaWorks Lewisville, United StatesLocation: 14476 GroßGlienicke | Contract Type: Part-time, permanent | Job ID: 842403 · PENNY is part of the REWE Group and employs over employees in around 2,140 stores, 10 logistics locations, and headquarters. In the PENNY team, we are strong together and treat each other with ...
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Director, Quality Operations
4 weeks ago
Quest Diagnostics Incorporated Denton, United StatesThe Director, Quality Operations will be responsible to lead site-level Quality Control & Quality Assurance function activities, the Quality Management Systems (QMS), assure compliance to USA FDA GXP regulations across IVD products and all regulatory audit and inspection activiti ...
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Manager Quality Operations
4 weeks ago
UnitedHealth Group Dallas, United StatesOpportunities at WellMed, part of the Optum family of businesses. We believe all patients are entitled to the highest level of medical care. Here, you will join a team who shares your passion for helping people achieve better health. With opportunities for physicians, clinical st ...
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Quality Machine Operator
4 weeks ago
Multi-Color Corporation Fort Worth, TX, United StatesBuild your Career with an Industry Leader · As the global leader of premium labels, MCC helps brands stand out in competitive markets and inspire positive consumer experiences. Backed by over a century of printing experience, MCC is focused on the future by developing consumer-d ...
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URBAN PAWS INC Dallas, United StatesJob Description · Job DescriptionUrban Paws is looking for a supervisor for our dog loving pack leaders. You will need to oversee and supervise large groups of dogs to ensure a safe and clean environment. This position also includes the responsibility of keeping the facility clea ...
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Senior Manager Packaging Operations
6 days ago
Mary Kay Lewisville, United StatesDirects and develops all Packaging Operation business units (Packaging, Packaging Maintenance, Cell Engineering, Contract Labor Services, Operations Cell Budget, Headcount, Safety, Quality and Production Planning) functions related to the manufacture of Mary Kay, Inc. products co ...
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Machine Technician
2 weeks ago
Mary Kay Lewisville, United StatesJob Summary: · Under direct supervision, serves as primary maintenance resource for packaging production operations. Contributes to ensuring safe working practices are followed and contributes ideas to simplify and standardize the workplace. Shares ownership in achieving world-c ...
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registered nurse denton
4 weeks ago
Res-Care, Inc. Lewisville, TX , USA, United StatesOur Company · ResCare Community Living · Overview · Join a team of passionate and caring clinicians who make a difference in people's lives. Our nursing group focuses on compassion and meeting the needs of our clients in a variety of settings. If your passion is outstanding patie ...
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Quality Control Laboratory Manager
5 days ago
Simply Biotech Lewisville, United StatesQuality Control Lab Manager- Simply Biotech · OVERVIEW · Are you looking for a new career opportunity with an exciting biotech company? Then we've got the right team for you In this role, you're responsible for the duties listed below. · Immediate opening for a Quality Contr ...
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Surface Mount Assembly Team Lead
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Ericsson Lewisville, United StatesDescription · Lewisville, Texas · Surface Mount Assembly (SMA) Team Lead · About this opportunity · To scale our operations and meet the demands of our customers, the Ericsson US 5G Smart Factory is hiring additional Team Leads for our Surface Mount Assembly (SMA) Lines. T ...
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Manuel Machinist
2 weeks ago
Mid-Cal Labor Solutions Lewisville, United States· Job description · We are seeking a skilled and experienced Manuel Machinist to join our team. As a manual machinist, you will be responsible for operating and maintaining various types of machinery to produce precision parts and components. If you have a strong mechanical apti ...
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Quality Control Inspector
5 days ago
XL Pro Staffing and Consulting Group Lewisville, United StatesVision Statement: · At XL Pro Staffing & Consulting, our mission is to redefine success by matching exceptional talent with outstanding opportunities. We are dedicated to providing personalized, transparent, and innovative staffing solutions that not only meet the needs of our cl ...
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Quality Control Laboratory Manager
4 days ago
Simply Biotech Lewisville, United StatesQuality Control Lab Manager- Simply Biotech · OVERVIEW · Are you looking for a new career opportunity with an exciting biotech company? Then we've got the right team for you In this role, you're responsible for the duties listed below. · Immediate opening for a Quality Contr ...
Director, Quality Operations - Lewisville, United States - Quest Diagnostics Incorporated
Description
The Director, Quality Operations will be responsible to lead site-level Quality Control & Quality Assurance function activities, the Quality Management Systems (QMS), assure compliance to USA FDA GXP regulations across IVD products and all regulatory audit and inspection activities.
This position will be responsible for translating the company's quality strategy into SOPs, tactical policies, processes, and procedures to always ensure compliance with meeting global regulatory standards.
The scope of the role includes but is not limited to Raw Material / Component release, Quality & Validation Engineering, and Site Compliance & Inspection Readiness.
The role is responsible for developing both short-term tactical objectives and execution plans in addition to longer term strategies to drive efficiencies through simplification of Quality processes and procedures while driving continuous improvement in manufacturing quality, product quality and compliance performance.
Director, Quality Operations professionals in Lewisville
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David Siri
Operation Experience Representative