Director of Quality Management Systems

3 weeks ago

Baltimore, United States CareerBuilder Full time

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

  • Director of Quality

    6 hours ago

    Baltimore, United States Brightpathassociates Full time

    The client is a global leader in the design, manufacture and support of innovative electronic systems for the United States government. Location Annapolis Junction, MD Summary The Quality Manager will be a proven leader with excellent problem-solving and communication skills to manage the quality of company products and documentation. This individual will be...

  • Learning Management System Administrator

    3 days ago

    Baltimore, United States Cynet Systems Full time

    Job Description: Pay Range: $55hr - $60hr Responsibilities: Setting up and configuring the LMS: The LMS Administrator is responsible for setting up and configuring the LMS to meet Client't specific needs. This includes customizing the "look and feel" of the system, creating user accounts, generating reports, and establishing proper security and access...

  • Manager Quality Systems and Operational Workflow

    4 weeks ago

    Baltimore, United States Accelevir Diagnostics Full time

    Job DescriptionJob DescriptionAccelevir Diagnostics is a growing Baltimore, Maryland biotechnology company creating innovative molecular and immunology assays. Our approach for detection of ultra-rare analytes includes expertise spanning virology, immunology, and genomics.  Our team develops, scales, and commercializes complex assay workflows to support...

  • Assistant Deputy Director/Administration

    7 days ago

    Baltimore, United States City of Baltimore, MD Full time

    THIS IS A NON-CIVIL SERVICE POSITION CITY OF BALTIMORE, DEPARTMENT OF GENERAL SERVICES OPERTIONS DIRECTOR I, ASSISTANT DEPUTY DIRECTOR/ADMINISTRATION OPENING DATE: 1/04/2024 CLOSING DATE: Open Until Filled The Baltimore City Department General Services is seeking an Assistant Deputy Director of Administration. Agency Overview The Department of General...

  • Director of Shwb Technology Systems, Data and

    7 days ago

    Baltimore, United States Johns Hopkins University Full time

    The Johns Hopkins University Student Health & Well-Being (SHWB) Practice Group is seeking a**_ Director of SHWB Technology Systems, Data and Reporting Strategis_**_t, _as part of the central office team and reporting to the Vice Provost for Student Health and Well-Being. The Student Health & Well-Being (SHWB) Practice Group provides holistic services that...

  • Manager, Quality Improvement

    3 weeks ago

    Baltimore, United States University of Maryland Medical System Full time

    Job DescriptionJob DescriptionCompany DescriptionRenowned as the academic flagship of the University of Maryland Medical System, our Magnet®-designated facility is a nationally recognized, academic medical center with opportunities across the continuum of care. Come join UMMC and discover the atmosphere where talents and ideas come together to enhance...

  • Program Manager Iv

    7 days ago

    Baltimore, United States State of Maryland Full time

    **Introduction**: Maryland’s Family and Medical Leave Insurance (FAMLI) program makes sure all workers in Maryland have paid time off for medical and family reasons. FAMLI is a social insurance system covering 2.8 million workers and 180,000 employers, delivered as a digitally native, public-facing service. We’re in the early stages of building...

  • Manager, Quality Improvement

    4 weeks ago

    Baltimore, United States University of Maryland Medical System Full time

    Job Description Under limited supervision, leads the Quality Improvement team in the mission of improving clinical quality at UMMC. Responsible for planning, coordinating, leading and monitoring quality improvement initiatives across the organization and within clinical service departments, frequently across both campuses. In coordination with the...

  • Director, Training-HealthCare Quality-Remote

    1 week ago

    Baltimore, MD, United States Department of Veteran Affairs Full time

    The VA is committed to serving and honoring the men and women who are America's Veterans. The VA Capitol Health Care Network’s (VISN 5) is currently seeking an experienced Emergency Medicine Board-Certified Physician to serve as our Tele-Emergency Care Director . This position is responsible for the leadership, management, and operations of the...

  • Quality Manager

    1 week ago

    Baltimore, United States Teijin Full time

    Teijin Automotive Technologies (TAT) is an innovative and full-service Tier One supplier with a global presence and emphasis in development for lightweight technologies. TAT offers employees the opportunity to join a leading edge company within the composite material industry and enjoy the benefits offered by a growing company in North America and...

  • Quality Engineer

    1 day ago

    Baltimore, United States Middle River Aerostructure Systems Full time

    Position Title: Quality Engineer Location: Baltimore, MD, US, 21220 Date: Tue, 14 May :04:39 CDT Company Name: STENAHCM20 Description: About Us: Middle River Aerostructure Systems is a world-leading manufacturer of thrust reversers (the braking system on a jet engine), engine nacelle components and specialized aerostructures. It supplies and supports these...

  • Executive Assistant to The Executive Director

    2 days ago

    Baltimore, United States City of Baltimore, MD Full time

    THIS IS A NON-CIVIL SERVICE POSITION POSTING DATE: 05/14/2024 CLOSING DATE: 08/13/2024 AT 12:00 MIDNIGHT SALARY: $53,881.00 - $86,210.00 Annually AGENCY OVERVIEW The Baltimore City Fire and Police Employees’ Retirement System (F&P, Plan, System) was established July 1, 1962, by City law and has been amended periodically. and. The Baltimore City Fire...

  • it director ii

    2 weeks ago

    Baltimore, Maryland, United States State of Maryland - MD Institute for Emergency Medical Svcs Systems Full time

    GRADE22 \r LOCATION OF POSITION653 W. Preston St.,\rBaltimore, MD 21201\r Main Purpose of JobThe IT Deputy Director manages day-to-day operations of the IT Division. The division supports the agency mission by designing, implementing, and managing the network infrastructure, data backup systems, physical and virtual server environments; laptop and desktop...

  • it director ii

    6 days ago

    Baltimore, Maryland, United States State of Maryland - MD Institute for Emergency Medical Svcs Systems Full time

    GRADE22 \r LOCATION OF POSITION653 W. Preston St.,\rBaltimore, MD 21201\r Main Purpose of JobThe IT Deputy Director manages day-to-day operations of the IT Division. The division supports the agency mission by designing, implementing, and managing the network infrastructure, data backup systems, physical and virtual server environments; laptop and desktop...

  • Regional Safety Director

    7 days ago

    Baltimore, United States Structural Preservation Systems, Inc. Full time

    Description Discover a career at STRUCTURAL, a prominent industry player specializing in innovative infrastructure repair solutions. Renowned for our commitment to excellence, we stand out as a leader in the field. As the largest U.S. concrete repair contractor, our extensive range of specialty services is delivered by a dedicated team of 2,500 employees...

  • Mental Health Program Director

    3 weeks ago

    Baltimore, United States Change Health Systems I Full time

    Job DescriptionJob DescriptionA fast-growing community based behavioral health clinic is seeking a highly skilled Clinic Program Director. This position is based out of our Baltimore, Maryland office.Position: Clinic Program DirectorReports to: Executive ManagementLocation: Baltimore, MDSupervision: TherapistsEmployment Type: Full-Time EmployeeBenefit...

  • Director of Budget

    3 weeks ago

    Baltimore, Maryland, United States Baltimore City Community College Full time

    DetailsPosted: 18-Nov-23Location: Baltimore, MarylandSalary: OpenInternal Number: The Director of Budget is a key leader of the Finance and Administration department, and within the Organization. Functionally, s/he is responsible for ensuring that the US-based accounting, treasury, and statutory and management reporting systems and policies provide high...

  • Director, Women United

    4 weeks ago

    Baltimore, United States United Way of Central Maryland Full time

    ** STATEMENT**: The Director, Women United develops, directs, and executes strategies to increase giving to United Way through growing the Women United membership network through acquisition, retention, and increased giving from current members. The Director partners with Relationship Managers to grow membership revenue in workplace accounts. The Director...

  • Senior Systems Administrator

    2 days ago

    Baltimore, United States Incognito Software Systems Full time

    Senior Systems Administrator page is loaded Senior Systems Administrator Apply locations United States - Maryland time type Full time posted on Posted Yesterday job requisition id R49864 Job Summary: We are seeking an experienced and knowledgeable Senior Systems Administrator to join our information technology and security team to utilize the latest...

  • HR Program Manager

    1 week ago

    Baltimore, United States Cynet Systems Full time

    Job Description: Pay Range $70hr - $80hr Responsibilities: Manages assigned HR team members through all project phases: needs assessment, system analysis, implementation, development, maintenance and support. Identifies gaps in systems performance and user requirements and develops quality control measures to ensure new design closes this gap. ...