Director of Quality Management Systems
1 month ago
Job Description
Job Overview:
The Director of Quality Management Systems ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing a role in any one or more of the following functions: Quality Systems (Change Controls, Complaints, CAPAs, Investigations and Supplier Quality) and Compliance in accordance with cGMP and related company SOP's, state, federal and local laws as applicable.
Responsibilities:
To execute and drive the site's quality policies and procedures, evaluate and where needed contribute to its continuous improvement.
To lead quality assurance oversight of operations performed within the site, such as quality systems & compliance.
To lead, support or contribute to the preparation, review, and approval of QA-related documentation in accordance with approved SOPs.
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.
To ensure that the site's quality standards, practices, procedures, and documentation are in accordance with regulatory, pharmacopoeia and company requirements as well as industry standards and best practices.
To support regulatory and customer inspections and to maintain a state of inspection readiness.
To lead, monitor, manage and drive continuous improvement of site Quality 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.
Master’s degree or higher, in Life Sciences, Pharmacy, Engineering, Industrial Management, Operations, Quality is preferred.
Minimum of 1O+ years relevant work experience in Quality Assurance or in combination with relevant
education/experience.
5+ years of leadership experience
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.
Demonstrates good leadership skills and the ability to establish and maintain good working relationships with other departments, including vendors, 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 such as MasterControl and Trackwise.
Demonstrate the ability to effectively train others on programs and procedures.
Demonstrate solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
Good understanding of cGMPs, industry, and regulatory standards and guidelines.
Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
Demonstrate the ability to portray the 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.
Results-oriented and efficient.
Creative and open-minded 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.
Physical Demands:
Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
Ability to lift up to 40 pounds on occasion.
Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
#J-18808-Ljbffr
We have other current jobs related to this field that you can find below
-
Director, Project Management
2 months ago
Cockeysville, United States Ultimate Staffing Full timeThe Director of Project Management oversees the entire project management department and department performance. The Director will be charged with creating the PM vision & plan, collaborating with other leaders, supporting the PM team as a mentor, and managing workload and assignments. Other highlights include leading the team to ensure a high level of...
-
Director, Communication
4 weeks ago
Cockeysville, United States McCormick & Company, Incorporated Full timeSelect how often (in days) to receive an alert: Director, Communication & Change Management HUNT VALLEY, MD, US, 21031 McCormick & Company, Inc., a global leader in the spice, flavor, and seasonings industry, is seeking a full-time Director, Communication & Change Management to join our Organizational Effectiveness team. The Director, Communication & Change...
-
Director, IT
3 weeks ago
Cockeysville, United States The Amynta Group Full timeWe're thrilled that you are interested in joining us here at the Amynta Group! The Director of IT for PDP is a leadership role that drives transformational change and technological innovation across the organization. This position is responsible for overseeing objectives and strategies for the IT department in collaboration with business unit leaders, and...
-
Managed IT Systems Engineer
3 months ago
Cockeysville, United States Advance - Global Australian Professionals Full timeDescription Position at Advance WHO WE ARE Advance is a business solutions provider that helps organizations in Maryland find better, more effective technology and processes to help improve their business and increase efficiencies. Family owned since 1964, our mission statement has been the guiding principle behind everything we do: "We are a people...
-
Managed IT Systems Engineer
2 weeks ago
Cockeysville, United States Advance Full timeJob DescriptionDescription Position at Advance WHO WE ARE Advance is a business solutions provider that helps organizations in Maryland find better, more effective technology and processes to help improve their business and increase efficiencies.Family owned since 1964, our mission statement has been the guiding principle behind everything we do: "We are a...
-
Service Manager
2 weeks ago
Cockeysville, United States AutoNation Full timeJob Requirements Job Profile Summary The Service Manager is responsible for the customer-focused and efficient operation of the dealership'sservice department. The service manager will operate the department at maximum production, controllingcosts, building a loyal clientele, maintaining good employee relationships, setting and obtaining salesobjectives and...
-
Financial Analyst III, Systems and Processes
3 weeks ago
Cockeysville, United States McCormick & Company, Incorporated Full timeSelect how often (in days) to receive an alert: Financial Analyst III, Systems and Processes HUNT VALLEY, MD, US, 21031 McCormick & Company, Inc., a global leader in the spice, flavor, and seasonings industry, is seeking a full-time Financial Analyst III, Systems and Processes . This new hire will work at the Global Headquarters , locatedin Hunt Valley, MD ....
-
Service Manager
2 weeks ago
Cockeysville, Maryland, United States AutoNation Full timeJob Requirements Job Profile Summary The Service Manager is responsible for the customer-focused and efficient operation of the dealership'sservice department. The service manager will operate the department at maximum production, controllingcosts, building a loyal clientele, maintaining good employee relationships, setting and obtaining salesobjectives and...
-
Financial Analyst III, Systems and Processes
2 months ago
Cockeysville, United States McCormick & Company, Incorporated Full timeSelect how often (in days) to receive an alert: Financial Analyst III, Systems and Processes HUNT VALLEY, MD, US, 21031 McCormick & Company, Inc., a global leader in the spice, flavor, and seasonings industry, is seeking a full-time Financial Analyst III, Systems and Processes . This new hire will work at the Global Headquarters , locatedin Hunt Valley, MD ....
-
Director, Business Development
4 weeks ago
Cockeysville, United States Sunstone Credit Full timeJob DescriptionJob DescriptionAbout Us Sunstone Credit is a financial technology company working to help businesses go solar.Solar in the United States is an exciting, accelerating industry. In 2021, over half of all new electricity-generating capacity was solar. Homeowners and really large businesses are increasingly installing solar, but we need to...
-
Marketing Director
2 months ago
Cockeysville, United States Sinclair Broadcast Group Full timeJob Description Compulse is seeking a talented and experienced Marketing Director to lead our marketing efforts and drive the development and execution of strategic marketing initiatives. As the Marketing Director, you will play a pivotal role in shaping Compulse's brand identity, generating demand for our services, and expanding our market presence. You...
-
Marketing Director
2 weeks ago
Cockeysville, United States Sinclair Broadcast Group Full timeJob Description Compulse is seeking a talented and experienced Marketing Director to lead our marketing efforts and drive the development and execution of strategic marketing initiatives. As the Marketing Director, you will play a pivotal role in shaping Compulse's brand identity, generating demand for our services, and expanding our market presence. You...
-
Marketing Director
7 days ago
Cockeysville, United States Sinclair Broadcast Group Full timeJob Description Compulse is seeking a talented and experienced Marketing Director to lead our marketing efforts and drive the development and execution of strategic marketing initiatives. As the Marketing Director, you will play a pivotal role in shaping Compulse's brand identity, generating demand for our services, and expanding our market presence. You...
-
Sr. Systems Engineer
2 months ago
Cockeysville, United States Sinclair Broadcast Group Full timeTo support our growing team, we are looking for a Senior Systems Engineer to join the ONE Media Lab team. As a Senior Systems Engineer, you will help innovate, build, and support our rapidly expanding next generation IP broadcast platform. This employee will be working on site in our Hunt Valley office, in the One Media Lab. Responsibilities: Support...
-
Supervisor, Automotive Account Management Team
2 weeks ago
Cockeysville, United States Sinclair Broadcast Group Full timeSinclair Digital Group is looking for an experienced Digital Account Manager with expertise in the operations and marketing of auto dealerships to help lead our automotive account management team as a team supervisor. The person in this position will become an integral part of our company-wide sales initiative focused on the tier 3 auto business. We are...
-
Systems Engineer
1 month ago
Cockeysville, United States Sinclair Broadcast Group Full timeJob DescriptionWho is ONE Media Technologies? We are at the forefront of creating and deploying a remarkable new "Next Generation" platform for the broadcast television ecosystem. This wireless, "All-IP" (Internet Protocol)-based platform is designed to enhance over-the-air broadcasting dramatically, with a vast new set of 'tools' to provide multiple data...
-
Systems Engineer
1 month ago
Cockeysville, United States Sinclair Broadcast Group Full timeWho is ONE Media Technologies? We are at the forefront of creating and deploying a remarkable new “Next Generation” platform for the broadcast television ecosystem. This wireless, “All-IP” (Internet Protocol)-based platform is designed to enhance over-the-air broadcasting dramatically, with a vast new set of ‘tools’ to provide multiple data...
-
Maintenance Technician
1 month ago
Cockeysville, United States Hirschfeld Management Inc Full timeJob DescriptionJob DescriptionHirschfeld Properties currently owns and manages a portfolio of premier apartment communities in central Maryland. Hirschfeld is seeking a skilled Maintenance Technician to join our dynamic team. As a leading property management company, we are committed to providing exceptional service to our residents and maintaining the...
-
Maintenance Technician
3 weeks ago
Cockeysville, United States Hirschfeld Management Inc Full timeJob DescriptionJob DescriptionHirschfeld Properties currently owns and manages a portfolio of premier apartment communities in central Maryland. Hirschfeld is seeking a skilled Maintenance Technician to join our dynamic team. As a leading property management company, we are committed to providing exceptional service to our residents and maintaining the...
-
Project Estimator
3 months ago
Cockeysville, United States Ecological Restoration & Management Full timeCompany DescriptionEcological Restoration and Management, Inc. (ER&M) is an established landscape construction firm specializing in environmental restoration, land management services, and commercial landscaping. Since incorporating in 1983, ER&M has focused on a wide range of projects, including wetland creation, stream restoration, shoreline stabilization,...
