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

Associate Director, Clinical Data Management

The Associate Director, Clinical Data Management plays a key role within the Cli...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

At least 10 years of experience in clinical data management, including direct collaboration with CROs and data management vendors
Comprehensive knowledge of FDA and ICH/GCP regulations and their application to data management processes
Proficiency in CDISC standards (CDASH/SDTM), medical coding dictionaries, 21 CFR Part 11 compliance, and industry best practices in clinical data management
Exceptional interpersonal, communication, and organizational abilities, with a demonstrated capacity to manage multiple programs and workflows in a dynamic, team-oriented setting
Proven success in managing vendor relationships and functional service provider (FSP) partnerships
Strong track record of building effective relationships and managing expectations with external partners and vendors
Practical experience with electronic Trial Master File (eTMF) systems related to CDM documentation
Bachelor’s degree or higher in Life Science or related discipline

Job Responsibility

Provide project-level leadership for clinical data management (CDM) activities, monitor and report on overall study progress
Develop and maintain study timelines and ensure timely delivery of data-related milestones in collaboration with cross-functional teams and external vendors
Oversee the creation of study-specific CDM documentation, including eCRF specifications, completion guidelines, edit check specifications, and data management plans—proactively identifying and mitigating risks to data quality and ensuring appropriate filing in the Trial Master File (eTMF)
Manage CRO CDM counterparts to ensure compliance with scope of work, contractual agreements, timelines, and quality standards
Conduct end-to-end testing of electronic case report forms (eCRFs), including authoring and executing User Acceptance Test (UAT) plans and scripts prior to deployment
Develop and execute risk mitigation and action plans as needed to maintain data integrity and operational efficiency
Actively participate in internal study team discussions and engage with external stakeholders through vendor teleconferences
Serve as a primary liaison to internal partners (Clinical Operations, Biometrics, Safety/Pharmacovigilance, Regulatory Affairs) and external entities (CROs, third-party data vendors)
Monitor vendor performance and quality
escalate issues to management and implement corrective actions as appropriate

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Director of Clinical QA

Responsible for building and leading cross-functional quality assurance systems ...

Location

United States

Salary:

175000.00 - 200000.00 USD / Year

Loyal

Expiration Date

Until further notice

Requirements

Bachelor’s degree in STEM or related field
Minimum 10+ years of experience in Clinical Quality Assurance or Clinical Operations (must be in Animal Health), with at least 5 years in a leadership role
Experience in one of the following regulatory compliance practices: GCP (VICH) or GLP practices (prefer GCP) in animal health pharmaceuticals (not human health)
Willing to familiarize yourself with regulatory practices in which you may not have experience
Track record of success and a broad understanding of current QA practices as they apply to animal health clinical trials and quality assurance
In-depth knowledge of FDA-CVM and other international clinical research regulations
Proven experience in managing audits, inspections, and CAPA systems
Strong leadership, communication, and collaboration skills
Ability to influence cross-functional teams and drive a culture of quality and compliance

Job Responsibility

Lead the design and execution of the Clinical Quality Assurance strategy to ensure GCP compliance across all studies
Oversee and manage the clinical audit program, including investigator site audits, vendor audits, and internal process audits
Develop, implement, and maintain policies, SOPs, and training programs to support compliance with global regulations (FDA, EMA, VICH-GCP, etc.)
Partner with Clinical Operations, Regulatory, and other cross-functional teams to proactively identify and mitigate quality and compliance risks
Provide quality oversight of vendors and CROs to ensure adherence to contractual and regulatory obligations
Support clinical trial inspections (FDA, EMA, etc.) and lead preparation and response activities
Analyze audit trends and inspection findings to develop continuous improvement initiatives
Serve as the company’s subject matter expert (SME) on GCP-related quality and compliance matters
Review all protocols, data and reports being generated under GLP/GCP
Manage and respond to adverse events (with clin ops) for drug products in the clinic and beyond

What we offer

Full-coverage health insurance — medical, dental and vision — for you and your dependents
$1,000 home office equipment stipend
$1,200/year learning budget for books, courses, etc.
$250/month wellness budget for gym, cleaners, spa, food, etc.
All 3-day weekends are turned into 4-day weekends
Unlimited vacation and paid holidays
Paw-ternity leave — adopt a dog and get a day off with your new family member
Competitive salary
Company equity options grant for new hires

Fulltime

New

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

New

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

New

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

Senior Director, Nursing Quality & Magnet Program

The Senior Director of Nursing Quality and Magnet Program Director (MPD) is an I...

Location

United States , Brookline

Salary:

225200.00 - 253000.00 USD / Year

Dana-Farber Cancer Institute

Expiration Date

Until further notice

Requirements

Master’s degree in Nursing or a health-related field required
DNP or PhD strongly preferred
Licensed as a Registered Nurse in the Commonwealth of Massachusetts and/or New Hampshire, as applicable
10+ years of progressive nursing leadership experience, including substantial administrative responsibility
oncology experience strongly preferred
Demonstrated success leading ANCC Magnet initial designation and re-designation efforts in complex or multi-site organizations
Specialty certification in Oncology, Education, or Administration required within 2 years
Nurse Executive–Advanced (NEA-BC) preferred
Additional quality/process improvement certifications preferred (e.g., CPHQ, Lean Six Sigma, or equivalent)
Experience with program development, evaluation, complex change management, and enterprise analytics required

Job Responsibility

Set the vision and multi-year strategy for nursing quality, Magnet performance, and professional practice excellence
align goals with the Institute’s strategic plan and the nursing strategic plan
Lead system-wide professional governance, optimizing structures, chartering councils, and ensuring strong bidirectional communication and decision-making across nursing and interprofessional teams
Partner with the CNO, NEC, and Institute Quality and Safety leadership to develop and execute the annual Nursing Quality and Magnet Advancement Plan
Identifies operational risks and key performance indicators
maintains dashboards and drives accountability across functions
Provides direction and is accountable across multiple functions with broad organizational impact
Serve as the organization’s senior executive for the ANCC Magnet Program
oversee gap analyses, documentation, sources of evidence, empirical outcomes, site visit preparation, and post-visit sustainment
Ensure integration of Magnet domains into policies, education, and daily practice

Fulltime

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

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