Jobs
>
Baltimore

    Director of Quality Management Systems - Baltimore, United States - PeopleSuite

    PeopleSuite
    PeopleSuite Baltimore, United States

    2 weeks ago

    Default job background
    Description
    Scope of Position

    The Director of Quality Management Systems ensures compliance with CGMPs and internal policies, procedures, and specifications.

    This position is responsible for performing leading the following functions:

    Quality Management Systems (Change Controls, Complaints, CAPAs, Investigations, OOS/OOTs, EQMS, Document Control) and responsible for ensuring these systems operate in compliance with global CGMPs, applicable company SOP's, state, federal and local laws, as applicable.

    Responsibilities

    To execute and drive the site's quality culture, policies, and procedures. Continuously evaluate, and where needed, contribute to its continuous improvements to Quality Management Systems.
    To lead Quality Assurance oversight of operations performed within the site.
    To lead or contribute to the preparation, review, and approval of QA-related documentation per approved SOPs or applicable standards.

    To drive the timely closure of general organizational tasks including oversight and escalation of open tasks and timelines, tracking of tasks, and reporting of quality metrics (e.g., Investigations, CAPAs, Complaints, Change Controls, Trends, etc.).

    To drive change to ensure that the site's quality standards, practices, procedures, and documentation are per regulatory, pharmacopeia, industry standards / best practices and adopted as deemed appropriate to company requirements.

    To support regulatory and customer inspections to maintain a state of inspection readiness.
    To lead, monitor, manage, and drive continuous improvement of site Quality Assurance KPl's.
    To sponsor and manage QA-related projects.

    To review and approve quality system documents to ensure that they comply with relevant SOPs, are GMP compliant, and meet regulatory requirements.

    To help remedy compliance issues appropriately when identified.
    Respond to external customers.
    To lead or participate in meetings to direct others, or to report on, contribute to, and/or resolve quality-related matters.
    To represent QA and provide QA-related expertise in various internal/external meetings.
    To monitor training completion and ensure both personal and departmental training status remains current.
    Lead team members and activities in respective areas as required.
    Perform other duties as assigned.

    Qualifications


    Bachelor's degree, or equivalent combination of education, training, and professional experience that provides the individual with the required knowledge, skills, and abilities.


    Preferred:
    Master's degree or higher, Life Sciences, Pharmacy, Engineering, Industrial Management, Business Administration or Operations.
    Minimum of 10 year's of relevant work experience in Quality Assurance or combination with relevant education/experience in GMP-related industries
    Minimum of 5 years of leadership experience, leading/creating high-performing teams.

    Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff.

    Strong experience with project and people management.
    Able to administer personnel performance evaluations.
    Demonstrate the ability to write and understand technical information and produce detailed reports and metrics.

    Demonstrates great leadership skills that include the ability to establish and maintain good working relationships with other departments, including vendors/clients, colleagues, and subordinates.

    Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
    Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
    Must be able to comprehend and follow all applicable SOPs.
    Demonstrate knowledge and experience with electronic Quality Management Systems (preferred: MasterControl and/or TrackWise Digital).
    Demonstrate the ability to effectively train others on concepts, programs, and procedures.

    Demonstrate a solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.

    Fundamental understanding of CGMPs, industry, and regulatory standards, and applicable guidelines.
    Demonstrate familiarity with Microsoft Office programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
    Demonstrate the ability to maintain an appropriate level of integrity and professionalism.
    Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
    Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
    Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
    Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
    Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged.
    Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
    Demonstrate the ability to work well in a cross-functional team environment.
    Must communicate fluently in English and have legible handwriting.

    #J-18808-Ljbffr
  • Northrop Grumman

    Manager Systems Engineering 1

    5 days ago

    Northrop Grumman Baltimore, United States

    **Requisition ID: R **: · - ** Category**: Engineering · - **Location**: Baltimore, Maryland, United States of America · - **Clearance Type**: Secret · - **Telecommute**: No · - Teleworking not available for this position · - **Shift**: 1st Shift (United States of America) · - ** ...

  • Horizon Dynamics

    Configuration Manager for Space Systems

    2 weeks ago

    Horizon Dynamics Ramblewood, United States

    Make it happen · You... · Are responsible for planning and implementing configuration management within the project landscape throughout the entire product lifecycle · Identify configuration items and ensure configuration control · Are responsible for identifying requirements ...

  • Anne Arundel County, MD

    IT Systems Support Manager

    2 weeks ago

    Anne Arundel County, MD Anne Arundel County, MD, United States

    **Position Description**: · NATURE AND VARIETY OF WORK · **Examples of Duties and Knowledge, Skills and Abilities**: · (Note: The duties and responsibilities enumerated in this class specification are for the purpose of determining a common set of minimum qualifications and salar ...

  • Kennedy Krieger Institute

    manager - systems engineering

    2 weeks ago

    Kennedy Krieger Institute Baltimore, United States

    Overview · The · Manager, Systems Engineering · supervises the production activities of the Institute's enterprise operations infrastructure, including file servers, disaster recovery, remote access strategy, endpoint security, mobile device management, and cloud services. In a ...

  • Clark Construction Group

    Systems/MEP Manager

    2 days ago

    Clark Construction Group Baltimore, United States

    Summary · As a Systems Manager, you have the opportunity to add to that legacy by being a part of the construction process from start to finish by utilizing your knowledge to drive successful completion of the project. You will be involved in all aspects of MEP from submittal to ...

  • Kennedy Krieger Institute

    manager - systems engineering

    1 week ago

    Kennedy Krieger Institute Baltimore, United States

    Overview: · The · Manager, Systems Engineering · supervises the production activities of the Institutes enterprise operations infrastructure, including file servers, disaster recovery, remote access strategy, endpoint security, mobile device management, and cloud services. In ...

  • Palo Alto Networks

    Systems Engineering Manager

    1 week ago

    Palo Alto Networks Baltimore, United States

    Our Mission · At Palo Alto Networks everything starts and ends with our mission: · Being the cybersecurity partner of choice, protecting our digital way of life. · Our vision is a world where each day is safer and more secure than the one before. We are a company built on the fou ...

  • Radiant Enterprises

    Training for IT system management clerk

    2 weeks ago

    Radiant Enterprises Carney, United States

    At Carney, you can combine your passion for technology with a commercial apprenticeship. Over the course of three years, practical experience will be combined with theoretical knowledge in an engaging way. During the apprenticeship, you will learn how to handle our systems (maint ...

  • The Annie E. Casey Foundation

    Manager of Systems And Applications

    3 weeks ago

    The Annie E. Casey Foundation Baltimore, United States

    The Annie E. Casey Foundation is devoted to developing a brighter future for millions of children and young people with respect to their educational, economic, social and health outcomes. The Foundations work focuses on strengthening families, building stronger communities and en ...

  • Direct Recruiters

    Systems Engineering Manager

    2 weeks ago

    Direct Recruiters Baltimore, United States

    -Our Client: Automated Material Handling Equipment manufacturer and integrator · -Sorters, Control Sorters, AI, Smart Vision, Conveyors, Package Handling · -Must have management experience, multi-disciplined engineering experience (electrical, mechanical & software) · -Oversees e ...

  • Kennedy Krieger Institute

    manager - systems engineering

    2 weeks ago

    Kennedy Krieger Institute Baltimore, United States

    Overview: · The Manager, Systems Engineering supervises the production activities of the Institutes enterprise operations infrastructure, including file servers, disaster recovery, remote access strategy, endpoint security, mobile device management, and cloud services. In additi ...

  • Palo Alto Networks

    Systems Engineering Manager

    1 week ago

    Palo Alto Networks Baltimore, United States

    Company Description · Our Mission · At Palo Alto Networks everything starts and ends with our mission: · Being the cybersecurity partner of choice, protecting our digital way of life. · Our vision is a world where each day is safer and more secure than the one before. We are a co ...

  • SilverLinx

    System Project Manager

    2 weeks ago

    SilverLinx Prince George, United States

    Your tasks: · Leading interdisciplinary project team members, across locations of development and product companies, in achieving set goals and tasks · Managing customer-specific application development, from requirements analysis to the productive use of injectors, pumps, periph ...

  • Whitman, Requardt & Associates, LLP

    Information System Security Manager

    1 week ago

    Whitman, Requardt & Associates, LLP Baltimore, United States

    At Whitman, Requardt & Associates, LLP, we are "People Focused and Project Driven". We have been in business for more than 105 years and we are known for our quality work and quality employees. This is your chance to join our team - help us to design the infrastructure and buildi ...

  • Anne Arundel County, MD

    Computerized Maintenance Management System

    2 weeks ago

    Anne Arundel County, MD Anne Arundel County, MD, United States

    **Position Description**: · Position Description · This position works in the Department of Public Work's Utilities Bureau and its primary function is to ensure that the Computerized Maintenance Management System (CMMS) asset inventory, maintenance and quality assurance of histor ...

  • Northrop Grumman

    Manager Systems Engineering 2

    2 weeks ago

    Northrop Grumman Baltimore, United States

    US CITIZENSHIP REQUIRED FOR THIS POSITION: Yes · RELOCATION ASSISTANCE: Relocation assistance may be available CLEARANCE TYPE: Polygraph TRAVEL: Yes, 10% of the Time · Description · At Northrop Grumman, our employees have incredible opportunities to work on revolutionary system ...

  • Johns Hopkins Medicine

    Epic Systems Development Manager

    2 weeks ago

    Johns Hopkins Medicine Baltimore, United States

    · Remote · Work from Home · Share This Page · Job Details · Requisition #: · Location: Johns Hopkins Health System, · Baltimore, · MD 21201 · Category: Information Technology · Schedule: Day Shift · Hybrid (Monday-Friday) 8:30am-5:00pm · This position requires 2 days a ...

  • Northrop Grumman

    Manager Systems Engineering 1

    5 days ago

    Northrop Grumman Baltimore, MD, United States

    Requisition ID: R · Category: Engineering · Location: Baltimore, Maryland, United States of America · Clearance Type: Secret · Telecommute: No- Teleworking not available for this position · Shift: 1st Shift (United States of America) · Travel Required: Yes, 10% of the Time · Pos ...

  • latitude

    Security System Project Manager

    2 weeks ago

    latitude Baltimore, United States

    Are you a results-driven and detail-oriented professional with a passion for leading complex security system projects? If you excel at managing teams and implementing cutting-edge security solutions, we have an exciting opportunity for you to join our team as a Security System Pr ...

  • Office of the Chief Financial Officer

    ERP Financial System Manager

    2 weeks ago

    Office of the Chief Financial Officer Baltimore, United States

    Government of the District of Columbia · Office of the Chief Financial Officer (OCFO) · System and Data Integrity Manager · $118, $153,233.00 · The Office of the Chief Financial Officer (OCFO) whose mission is to enhance the fiscal and financial stability, accountability and ...