Director, System Clinical Quality and Risk Management Job at Kirby Bates Associates (Wausau)

Director, Quality

Leads and oversees a comprehensive, efficient, and integrated hospital-wide Cont...

Location

United States , Waukesha

Salary:

Not provided

Copper Springs East

Expiration Date

Until further notice

Requirements

Registered Nurse with current state licensure highly preferred
clinical license required
BSN or BS/BA required
Minimum two (2) years in an acute hospital or rehabilitation setting required
prior supervisory experience preferred
Basic Life Support (BLS/CPR) required
certification preferred by APIC (American Practitioners of Infection Control) and NAHCQ (National Association of Health Care Quality)
Data analysis and reporting
CQPI methodologies (e.g., RCA, FMEA, PDSA)
risk management and patient safety facilitation

Job Responsibility

Provide leadership and oversight of the organization-wide CQPI program
Measure and assess performance by collecting, analyzing, and trending data to identify opportunities for improvement
Focus on improving processes and systems to drive clinical quality, safety, and operational performance
Direct, facilitate, and report on all aspects of risk management and patient safety
Investigate factors contributing to adverse outcomes and drive process/system changes
Direct the hospital-wide CQPI operations, including record reviews for quality indicators and reporting findings to leadership, Medical Executive Committee, Board of Managers, and other committees
Annually review hospital-wide plans for Infection Control (IC) and CQPI
establish goals and objectives for the coming year
Serve as liaison to local health officials
coordinate inspections and accreditation reviews with state and other regulatory agencies

What we offer

Health (Medical, Dental, Vision) and 401K Benefits for full-time employees
Competitive Paid Time Off
Employee Assistance Program - mental, physical, and financial wellness assistance
Tuition Reimbursement/Assistance for qualified applicants

Fulltime

Director of Quality

The Director of Quality Management assumes responsibility and accountability for...

Location

United States , Lynchburg

Salary:

Not provided

Copper Springs East

Expiration Date

Until further notice

Requirements

Registered Nurse with current state licensure highly preferred
Clinical license required
Certification preferred by APIC (American Practitioners of Infection Control), and NAHCQ (National Association of Health Care Quality)
BSN or BS/BA required
Two years of experience in an acute hospital or rehabilitation setting required
Previous supervisory experience preferred
Current Basic Life Support/CPR Card
Demonstrated ability to plan, coordinate, and evaluate PI activities, effective oral and written communication skills and proficiency in basic computer skills required
Working knowledge of staff development and the educational process, quality improvement, infection control/employee health, and safety/risk management standards
Effective oral and written communication skills, in English with additional languages preferred

Job Responsibility

Provides leadership and oversight of a comprehensive, efficient and integrated organization wide Continuous Quality Performance Improvement program
Measures and assesses performance through collection, analyses, and trending of data
Focuses on processes and systems to improve performance
Directs, facilitates, and reports on all aspects of services relating to risk management and patient safety
Investigates factors contributing to adverse outcomes in order to improve processes and systems
Encourages reporting on risk reduction strategies in an atmosphere which minimizes blame or retaliation
Fosters environment to reduce unanticipated adverse events and/or outcomes
Responsible for education of Continuous Quality and Performance Improvement and additional hospital-wide education and training
Directs the functions and operation of the hospital-wide continuous quality improvement program including review of records for indicators of quality, reports findings to leadership, Medical Executive Committee, the Board of Managers and other committees as appropriate
Responsible for education of Continuous Quality and Performance Improvement to hospital and medical staff

What we offer

Comprehensive medical, dental, and vision plans, plus flexible-spending and health- savings accounts
Competitive paid time off and extended illness bank package for full-time employees
Income-protection programs, such as life, accident, critical-injury insurance, short- and long-term disability, and identity theft coverage
Tuition reimbursement, loan assistance, and 401(k) matching
Employee assistance program including mental, physical, and financial wellness
Professional development and growth opportunities

Fulltime

Audit Director, Quality & Compliance

The Audit Director is responsible for leading the strategy, execution, and conti...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment
Demonstrated experience leading internal and external GxP audits
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP)
Experience supervising or mentoring employees
Strong analytical, organizational, and communication skills
Ability to manage competing priorities in a fast-paced, rapidly growing company
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
Experience preparing for and supporting regulatory inspections preferred
Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred

Job Responsibility

Develop and maintain the annual risk-based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains
Plan, schedule, and execute internal audits, vendor audits, and for-cause audits
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing
Evaluate organizational risk and adjust audit scope and approach accordingly
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards
Support team succession planning and capability building as the audit function grows
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT)
Oversee vendor and third-party audits to qualify and maintain GxP suppliers
Ensure timely issuance of audit reports, management responses, and CAPA plans

What we offer

health and retirement, PTO, and stock option plans

Director of Quality

As the Director of Quality, you will be responsible for leading operational qual...

Location

United States , Union City

Salary:

216481.00 - 237601.00 USD / Year

BillionToOne

Expiration Date

Until further notice

Requirements

8+ years quality leadership experience in a CLIA-certified laboratory environment with demonstrated ability to lead and manage people and teams
Deep understanding of CLIA, CAP, state laboratory regulations (including NYS Clinical Lab requirements)
Proven track record of successfully reducing quality issues through systematic improvement initiatives
Hands-on experience with supplier quality management, including qualification, auditing, and corrective action management
Experience implementing or optimizing quality processes in a regulated laboratory setting
Strong analytical skills with ability to analyze quality data, identify trends, and develop data-driven solutions
Demonstrated ability to work cross-functionally and influence without direct authority
Ability to work independently and cross-functionally to provide effective updates at executive level
Detail-oriented with well-developed organizational and problem-solving skills
Proven ability to communicate effectively both in writing and verbally with staff at all levels

Job Responsibility

Lead and execute operational quality programs including incident management, material management, supplier management, trending/monitoring, and compliance
Drive continuous improvement initiatives by conducting root cause analyses, implementing corrective actions, and optimizing processes to reduce nonconformances and enhance laboratory efficiency
Partner directly with Lab Operations, Supply Chain, R&D, and other stakeholders to solve problems and embed quality into daily workflows
Serve as subject matter expert for operational quality matters
personally lead critical investigations and improvement projects as needed
Driving systematic reduction of quality issues through root cause analysis, trend identification, and implementation of sustainable corrective actions
Establishing and tracking operational quality metrics (NCR, CAPA, Change Control, Preventive Maintenance, etc.) to drive data-driven decision making
Developing risk-based receiving inspection protocols that balance quality assurance with operational efficiency
Establishing acceptance criteria and sampling plans for incoming materials, reagents, and consumables
Ensuring laboratory quality systems operate effectively to support daily operations

What we offer

Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
Open, transparent culture that includes weekly Town Hall meetings
The ability to indirectly or directly change the lives of hundreds of thousands patients
Multiple medical benefit options
employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)

Fulltime

Systems Director, Population Health Service Organizations

The System Director of IT Population Health Services Organization (PHSO) is a le...

Location

United States , Phoenix

Salary:

67.92 - 101.02 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Bachelors Of Science - Information Technology, Health Informatics, or related field required
Masters Of Science - Information Technology, Health Informatics, or related field preferred
10+ years in healthcare IT, with 5+ years in a leadership role
Experience with managed care models (Medicare Advantage, ACO, Medicaid), HIE integration, and population health tools (e.g., Epic EZCap, QNext, Healthy Planet, Innovaccer,)
Experience with FHIR, HL7, CCD, APIs, and other interoperability standards
Familiarity with ACO, CIN, and value-based care models

Job Responsibility

Lead the design and implementation of IT systems that support managed care and population health objectives
Align systems architecture with organizational strategies related to value-based care, ACOs, Medicare Advantage, Medicaid, and commercial payer programs
Oversee integration of clinical and claims data to support whole-person care
Ensure systems support care coordination workflows, care management documentation, and chronic condition tracking
Manage platforms that support risk stratification, predictive modeling, and attribution logic
Collaborate with clinical leadership to build technology-enabled pathways for preventive care, care gaps, and patient engagement
Lead and mentor the End User Services team, ensuring excellent IT support for clinicians, case managers, analysts, and administrative staff
Develop and monitor SLAs, support KPIs, incident response times, and user satisfaction metrics
Oversee help desk operations, ticketing systems, desktop support, hardware/software provisioning, and user access governance
Direct the architecture and scalability of population health IT platforms and managed care applications

What we offer

medical
prescription drug
dental
vision plans
life insurance
paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually)
tuition reimbursement
retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

Quality Compliance Manager

We are hiring a Quality Compliance Manager, which will operate within the Genera...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of quality management experience
Bachelor’s degree and 4 years of quality management experience
Associate’s degree and 8 years of quality management experience
High school diploma / GED and 10 years of quality management experience
Experience in Quality Management, Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise
Thorough understanding of Clinical R&D activities and Global Regulations
Knowledge of the Regulatory Submission and Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions

Job Responsibility

Provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy
Provide independent and objective quality advice in support of clinical trial activities
Provide quality oversight for Amgen programs for all stages of products in clinical development
Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial
Support the establishment of regional expertise to ensure quality and compliance to local Regulations
Support Clinical Trial Teams for all quality management activities
Ensure TA-specific data integrity
Review clinical trial protocols
Actively seek and implement innovative and proactive quality oversight methodologies
Manage/support regulatory inspection and review responses

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Director of Quality Assurance, Clinical

Responsible for leading in the development, implementation and maintenance of QA...

Location

United States , Berkeley

Salary:

220000.00 - 235000.00 USD / Year

Caribou Biosciences

Expiration Date

Until further notice

Requirements

Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline
At least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry
Experience working in biologics is strongly preferred
Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
Proven track record in developing and implementing quality systems and processes in a clinical setting
Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Prior GLP experience with quality oversight and auditing studies/vendors (preferred)
Excellent verbal and written communication skills
Ability to lead cross-functional teams and independently prioritize work

Job Responsibility

Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws
Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements
Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams
Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline
Plan and oversee activities in support of regulatory submissions and inspections
Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI)
Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines
Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle
Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents
Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders

What we offer

Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
Generous paid vacation time, in addition to company-observed holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Employee stock purchase plan (ESPP)
Tuition reimbursement program

Fulltime

Vice President, Risk Management

ChristianaCare is one of the nation’s largest and most innovative health systems...

Location

United States , Wilmington

Salary:

Not provided

Kirby Bates Associates

Expiration Date

Until further notice

Requirements

Juris Doctor (JD) required
10+ years of progressively responsible legal experience in healthcare law, including litigation and risk management
Demonstrated success leading multi-disciplinary teams and managing external counsel
Deep knowledge of healthcare liability, insurance, and enterprise risk management
Experience in an integrated health system or academic medical center preferred

Job Responsibility

Provides strategic leadership for enterprise risk management, clinical risk mitigation, claims management, and insurance portfolio
Integrates legal, operational, and clinical expertise to reduce exposure, protect organizational assets, and support a culture of safety and high-quality care delivery
Leads the Directors of Clinical Risk Management and Claims Management
Partners closely with senior executives, clinical and operational leaders, outside counsel, brokers, and claims consultants

Director, System Clinical Quality and Risk Management

Kirby Bates Associates

Location:
United States , Wausau

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 28, 2025

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Director, System Clinical Quality and Risk Management

Director, Quality

Director of Quality

Audit Director, Quality & Compliance

Director of Quality

Systems Director, Population Health Service Organizations

Quality Compliance Manager

Director of Quality Assurance, Clinical

Vice President, Risk Management

Director, System Clinical Quality and Risk Management

Kirby Bates Associates

Location:United States , Wausau

Category:Health and Beauty

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:December 28, 2025

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Director, System Clinical Quality and Risk Management

Director, Quality

Director of Quality

Audit Director, Quality & Compliance

Director of Quality

Systems Director, Population Health Service Organizations

Quality Compliance Manager

Director of Quality Assurance, Clinical

Vice President, Risk Management

Location:
United States , Wausau

Category:
Health and Beauty

Contract Type:
Not provided

Job Posted:
December 28, 2025