- 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,
- methods, and validation protocols, equipment qualification documents. (e.g., process, method, etc.), Change control management.
- 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
-
Steel Operator
3 weeks ago
Unisite Design Llc Denton, United StatesThe Steel Operator works directly with team members to support production initiatives. They perform duties such as set up, operate, and tend various machines. · **Essential Duties and Responsibilities**: · - Operates specialty equipment which may include but is not limited to han ...
-
Material Handler
2 weeks ago
Unisite Design Llc Denton, United StatesThe Material Handler works directly with team members to support production initiatives. They are responsible for handling and moving materials and products throughout the factory. They perform duties such as proper loading, unloading, and safely transporting materials throughout ...
-
Call Center Manager
2 weeks ago
Choptank Community Health System, Inc.. Denton, United States**Call Center Manager** · **_ Choptank Community Health System's (CCHS) mission is to provide _**_Access_**_ to _**_exceptional, comprehensive, _**_and_**_ integrated _**_health care_**_._** · **Job Summary**: The Call Center Manager (CCM) at Choptank Community Health System (CCH ...
-
Warehouse Operator
3 weeks ago
Greene, Tweed Denton, United StatesAt **Greene Tweed**, you'll find the cutting-edge technology, world-class polymer expertise and endless advancement opportunities you'd expect from a multi-national industry leader. You'll find them all in an environment that embraces diversity in people and opinions, moves decis ...
-
Projectionist
2 weeks ago
Alamo Drafthouse Cinema - Denton Denton, United StatesThe Projectionist is responsible for and accountable for maintaining excellent presentation quality and the overall audio · visual experience for each of our guests. In addition, this person may coordinate work with outside vendors. · **DUTIES / RESPONSIBILITIES**: Specifically, ...
-
Driver - Long Term Care - Lake Forest - Ft Days
2 weeks ago
Good Samaritan Society Denton, United States**Careers With Purpose** · **Join our not-for-profit organization that has provided over 100 years of housing and services to seniors with a commitment to quality care and service in a Christian environment.** · **Facility**: GSS TX Denton Vlg · **Location**: Denton, TX · **Addre ...
-
Facilities and Safety Coordinator
2 weeks ago
Choptank Community Health System, Inc.. Denton, United States**Facilities & Safety Coordinator** · - **_Are you looking for meaningful, rewarding work that _**_provides access to exceptional, comprehensive, and integrated health care for all. Join our growing team here at Choptank Community Health._** · **Job Summary**: The Facilities & Sa ...
-
Medical Receptionist
2 weeks ago
North Texas ENT & Allergy Center Denton, United StatesDo you have a passion for health, wellness and changing lives? · Do you want to be a part of a movement that is empowering people in your community to take back their health? · And do you have a proven track record of providing exceptional customer service and building lasting pr ...
-
Production worker
1 week ago
ZephyrTech Denton, United StatesOur client is a medium-sized company specializing in the production of building materials, which are distributed throughout Europe. The working atmosphere is characterized by a strong social consciousness and flat hierarchies. To strengthen the team at our location in Wöllstein, ...
-
Baker (m/f/d) in part-time and full-time'
1 week ago
Orion Innovations Denton, TX, United States Freelance**ABOUT THE POSITION** · Do you love your craft, thrive in a team environment, and want to help create our certified organic baked goods in our glass bakery? Join our warm and welcoming team where every individual's contribution counts. Through your work, you will shape the daily ...
-
Production Assistant
1 week ago
Crimson Technologies Denton, TX, United States FreelanceFor our client in the logistics industry in Greven, we are currently seeking a hardworking production assistant to join our team in Denton, TX. Your dedication and expertise will contribute to the success of our company. Don't wait any longer - apply now online or via email. No m ...
-
Eclipse Enterprises Denton, United StatesWhat does this job involve?As a Media Technology Specialist for Printing (m/f/d), you will gain knowledge about printing techniques, such as flexographic or offset printing, as well as handling printing forms and colors. The training usually lasts three years. · Your responsibili ...
-
IT system administrator
3 weeks ago
Aurora Technologies West Denton, United StatesAbout us: · We, WILHELM KÖNIG MTM GmbH, are a medium-sized company based in Wertheim-Bestenheid and currently employ approximately 240 employees. We manufacture individual parts and complete assemblies in the field of hydraulics and clamping tools. From development to delivery of ...
-
Director of Administration
1 week ago
State of Maryland Denton, United States**Introduction**: · **GRADE**: · 19 · **LOCATION OF POSITION**: · MDH, Caroline County Health Department, Denton, MD · **Main Purpose of Job**: · The main purpose of this position is to serve as the Director of Administration for Caroline County Department of Health (CCHD). This ...
-
Food Service Assistant
1 week ago
Good Samaritan Society Denton, United States**Careers With Purpose** · **Join our not-for-profit organization that has provided over 100 years of housing and services to seniors with a commitment to quality care and service in a Christian environment.** · **Facility**: GSS TX Denton · **Location**: Denton, TX · **Address** ...
-
Technician, Maintenance I
1 week ago
Southwire Company LLC Denton, United StatesA leader in technology and innovation, Southwire Company, LLC is one of North America's largest wire and cable producers. Southwire and its subsidiaries manufacture building wire and cable, utility products, metal-clad cable, portable and electronic cord products, OEM wire produc ...
-
Director, Quality Operations
3 weeks ago
Quest Diagnostics Incorporated Lewisville, 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 ...
-
Dir, 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 inspect ...
-
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 ...
-
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 ...
Director, Quality Operations - Denton, 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.
