Quality Assurance Director- Healthcare jobs in Nebraska
Quality Assurance Director- Healthcare is responsible for overseeing the quality management and quality improvement programs for a healthcare facility. Directs quality assurance and compliance functions. Being a Quality Assurance Director- Healthcare ensures that policies and initiatives are efficient, meet patient expectations and are updated to reflect regulatory changes. Requires a bachelor's degree. Additionally, Quality Assurance Director- Healthcare requires a certification of registered nurse. Typically reports to a top management. The Quality Assurance Director- Healthcare manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. To be a Quality Assurance Director- Healthcare typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. (Copyright 2024 Salary.com)
Recently Added Quality Assurance Director- Healthcare jobs
Director, Quality Assurance, CMSU
- University of Rochester
-
Medicine, NE
FULL_TIME
-
Opening
Full Time 40 hours Range URG 116 Neuro-Ctr Health & Tech/CMSU
Schedule
8 AM-5 PM; OCC WKNDS
Responsibilities
GENERAL PURPOSE:
Oversees specific federal regulatory requirements to provide the University with oversight of high priority, federally regulated research compliance areas, and perform the following, on behalf of the Center for Health and Technology:- Manage, direct and oversee all aspects of internal and external quality and compliance systems relating to routine daily operations as well as the establishment of new quality standards and compliance systems supporting projects with territories outside of the United States and North America. Working closely with the Executive Director of Strategic Initiatives, continually modify, as necessary, current quality systems to comply with the Medical Device regulation (21 CFR Part 820) and the European Commission (EU) Clinical Trials Directive assuring the safe and compliant handling of investigational drugs and devices.
- Assure compliance with the elements of the EU Clinical Trial Directive so as to position and maintain CMSU quality systems as meeting or exceeding those standards. Direct university risk management for GMP research projects.
- Manage, direct and oversee implementation and ongoing compliance with the Medical Device Regulations through the establishment of a Quality System Review (QSR) Program that combines the core elements of the Corrective and Preventative Action Program (CAPA), Internal audit program, Vendor qualification and management programs, Continuous Quality Improvement (CQI) program and the Quality Assurance Technical working group. As lead QSR Manager, work closely with CMSU Leadership and other CHeT senior management staff to assure the CMSU is operating in compliance with quality standards as set forth in 21CFR 820.
- This position is responsible for developing, implementing, maintaining and providing leadership, strategic direction and oversight of compliance and training activities for FDA regulated research activities. The position ensures that all clinical research projects are carried out to the standards set forth by the International Conference on Harmonization (ICH) covering Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), for both FDA and EU regulations covering investigational drugs and devices.
- Direct the activities of the Quality Assurance Compliance Group within the CMSU. This group oversees all aspects of Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices associated with CMSU’s compliance with NYS, Federal, and ICH Regulations and other regulatory authorities. Responsible for overseeing, developing, and coordinating the delivery of appropriate GMP training on at least an annual basis for all CMSU personnel. Provide compliance consulting services to the University as needed.
- Provide compliance support for the release of clinical trial supplies to allow for timely distribution in accordance with the international standards of GCP/GMP regulations and client requirements. Conduct batch and production record reviews, as necessary liaise with external vendors to ensure compliance with project and regulatory standards
- Administration of all internal Quality Assurance (QA) systems including investigational drug and device procedures and processes – CAPA and CQI.
- Input and approval authority into all department operating policies and standard operating procedures to ensure federal and international regulatory standards are met.
- Responsible for the identification, budget/contract negotiation, implementation, validation, and user acceptance testing of all CMSU technology, including the inventory management system, in conjunction with the CHeT IT support team. Ensure all staff are trained on new technology at the time of implementation, and at least annually thereafter and as new hires come on board. Continually research industry trends for additional technology from which CMSU would benefit related to cGMP compliance, streamline procedures, cost reductions, etc. Obtain proposals, vet vendors, and develop annual technology budget for new purchases and for routine maintenance of existing technology.
- Manage, direct, and oversee policies and procedures governing the storage and security of department documentation systems. Implement, direct, and oversee stability and expiry/retest program for all ongoing studies. Interact directly with clients and analytical facilities to obtain needed reports, and extend/terminate stability protocols as dictated by each project. Work in close collaboration with the CMSU & CHeT Leadership and CHeT on all aspects of CMSU operational activities to ensure regulatory and QA requirements are met for all projects.
- Management of CMSU Quality Personnel
- Recruit, train, and supervise Quality Group. Recommends or approves action on appointments, promotion, salary or other related personnel issues. Responsible for ongoing and yearly performance evaluations of direct reports. Provides direction to individual staff members for staff development through personal instruction and scheduling participation in professional meetings, institutes, and seminars.
- Oversee team and ensures that the CMSU facilities and equipment remain in full compliance with all NYS, Federal, and ICH regulations associated with GMPs, GCPs, GLPs, and other regulatory agencies (e.g. OSHA), including the need to serve as on-site director in compliance with 21 CFR Part 210 & 211.
- Responsible to ensure that the CMSU’s time and effort is accurately reported by project to the CHET finance team for billing to each project.
- Manage, direct, and oversee vendor certification and qualification programs and Internal Quality Audit Program.
- Act as in-house consultant to all clinical research personnel on matters of international regulatory standards as necessary to maintain internal and regulatory compliance. Participate in external and internal inspections from client companies and international regulatory authorities.
QUALIFICATIONS:- Bachelor’s degree in biology, microbiology, chemistry, chemical engineering, or related scientific field required.
- 3 years of relevant experience or an equivalent combination of education and experience required.
- At least 8 years of Quality Assurance and/or Regulatory experience in the pharmaceutical or device industries preferred.
- 15 years of experience, regulatory Affairs Certification (RAC), Registered Quality Assurance Professional (RQAP), or similar industry certification preferred.
- Minimum of 5 years demonstrated effective strategic planning, analytical problem solving, and decision making; managerial and leadership skills and experience preferred.
- Strong working knowledge of International GCP/GMPs, compliance auditing, QA experience, and GCP/GMP Document Management systems.
- Strong interpersonal, presentation, written, negotiation, and communication skills, including writing skills.
- Strong working knowledge of investigational drug and device handling and distribution, as well as the conduct of clinical trials.
- Strong organizational and computer skills.
Pay Range
Pay Range: $107,224 - $160,846 Annually
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. - 2 Days Ago
Director of Quality Assurance (Food Manufacturing)
- KG Invicta Services (KGiS)
-
Omaha, NE
FULL_TIME
- Work Model: OnsiteType: FulltimeJob DescriptionThe Director of Quality Assurance reports directly to the CEO and is a member of the company's management team and food safety team. The Director is obli...
- 6 Days Ago
Quality Assurance
- Infrahire
-
Alda, NE
FULL_TIME
- InfraHire is looking for a Quality Assurance in Alda, NE.Job DescriptionThis role necessitates direct engagement and training with operators/inspectors, coupled with a professional aptitude for effect...
- 7 Days Ago
Quality Assurance
- IMKO
-
Lincoln, NE
FULL_TIME
- Job Description: Essential Functions: Understand and follow all quality assurance standards Product parts on molding machines and prepare parts for Post Production and/or shipping at or above a predet...
- 28 Days Ago
Director of Healthcare
- Heritage Communities
-
Grand Island, NE
FULL_TIME
- The Heritage at Sagewood is Hiring! Our Director of Healthcare Will: Oversee provision of services and overall well-being of community members by working with other medical care providers and our resi...
- 4 Days Ago
Director of Healthcare
- HERITAGE MANAGEMENT SERVICES INC
-
Grand Island, NE
FULL_TIME
- The Heritage at Sagewood is Hiring! Our Director of Healthcare Will: Oversee provision of services and overall well-being of community members by working with other medical care providers and our resi...
- 6 Days Ago
Quality Assurance Director- Healthcare jobs at Popular Companies
Director of Quality Assurance
- UniSea, Inc.
-
Redmond, WA
- Position Description: The Quality Assurance Director is responsible for overseeing Quality Assurance programs for both D...
- 6/10/2024 12:00:00 AM
Director of Quality Assurance
- Pulpmill Services Incorporated
-
Monroe, LA
- Pulpmill Services is currently looking for a candidate to join our team as a Quality Assurance Director. Pulpmill Servic...
- 6/9/2024 12:00:00 AM
Director I, Quality Assurance
- Fluor
-
Greenville, SC
- At Fluor, we are proud to design and build projects and careers. This requires teams that are as unique as the projects ...
- 6/8/2024 12:00:00 AM
Quality Assurance Director
- The Judge Group
-
Hanover, PA
- JDP is seeking a Director of Quality Assurance in Hanover, PA area! The candidate will be responsible for establishing a...
- 6/8/2024 12:00:00 AM
Director, Clinical Quality Assurance
- Alumis Inc
-
South San Francisco, CA
- Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune disease...
- 6/8/2024 12:00:00 AM
Director of Quality Assurance
- Talentry
-
Madison, WI
- Job Description Director of Quality Assurance Madison, WI. Biotech industry. Direct Hire. 170-200k Talentry is looking f...
- 6/7/2024 12:00:00 AM
Quality Assurance Director
- The Vomela Companies
-
Saint Paul, MN
- JOB SUMMARY The Director of Quality Assurance will manage quality systems processes, and procedures to assure product sa...
- 6/6/2024 12:00:00 AM
Quality Assurance Director
- RHA Health Services
-
Knoxville, TN
- We are hiring for: Quality Assurance Director Type: Regular If you are a positive and personable individual looking for ...
- 6/6/2024 12:00:00 AM
About Nebraska
The state is bordered by South Dakota to the north; Iowa to the east and Missouri to the southeast, across the Missouri River; Kansas to the south; Colorado to the southwest; and Wyoming to the west. The state has 93 counties and is split between two time zones, with the state's eastern half observing Central Time and the western half observing Mountain Time. Three rivers cross the state from west to east. The Platte River, formed by the confluence of the North Platte and the South Platte, runs through the state's central portion, the Niobrara River flows through the northern part, and the Rep...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Director- Healthcare jobs
$123,891 to $176,835
Most Popular Cities in Nebraska for Quality Assurance Director- Healthcare Jobs
What does a Quality Assurance Director- Healthcare do?
Quality Assurance Director- Healthcare in Santa Barbara, CA
In healthcare institutions, quality assurance (QA) teams work throughout the system to design policies and procedures that promote the best possible patient outcomes.
December 20, 2019
Quality Assurance Director- Healthcare in Washington, DC
A strong quality assurance program is the key to meeting patient expectations and initiating changes that improve patient comfort, clinical outcomes and patient satisfaction levels.
December 10, 2019