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

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

Asset Quality Lead, Director - FSP

The Asset Quality Lead (AQL) is responsible for driving GCP Quality by maintaini...

Location

Argentina

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

A scientific or technical degree is preferred
BS: 10+ years or equivalent
MS/MBA: 7+ years or equivalent
Ability to build strong network/knowledge/relationships with internal/external stakeholders
Strong, advanced knowledge, experience and expertise in ICH GCP, clinical trial development, and operational GCP quality management disciplines
Familiarity with the relevant key therapeutic area(s)
Advanced clinical trials experience, especially operational processes and/or systems
Strong interpersonal skills, ability to influence, engage leaders and ability to establish and maintain excellent working relationships across lines in a matrix organization
Experience of working on global initiatives or project teams
Appreciation of diverse needs of different regulatory requirements of various sites and countries

Job Responsibility

Ensure clinical development plan strategy and asset-level risks are incorporated into study and asset level risk management and oversight to support GCP Compliance
Strategically, utilize quality measures/data to monitor asset/study quality and identify potential risks, quality trends, and support state of quality reporting
Communicate key quality information across study teams and serve as GCP quality expert to study teams
Monitor submission risk and flag major risks for Category Quality Head review and other key stakeholders for review
Oversee study-level quality risk management activities, including driving Study Risk Profile development/maintenance and QTL implementation by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner
Develop and present quality point of view at governance and portfolio related meetings
Provide Study Team Inspection Readiness(IR) guidance and support to asset teams and pivotal study teams that have a high likelihood of regulatory inspection
lead teams through pre-submission dive and storyboards
Develop and maintain inspection readiness tools and processes
In conjunction with IMQA, coordinate business line GCP inspection support activities including but not limited to requests for dossiers, pre-inspection requests, during inspections and through the development of written responses to findings

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

Assistant Director of Nursing – Theatre Department

The Assistant Director of Nursing will be responsible to co-ordinate and manage ...

Location

Ireland , Lucan, Co. Dublin

Salary:

Not provided

Blackrock Health Hermitage Clinic

Expiration Date

Until further notice

Requirements

Be registered, or be eligible for registration, in the General Nurse Division, and other divisions as relevant to the specific service, of the Register of Nurses and Midwives, as appropriate, maintained by the Nursing & Midwifery Board of Ireland (NMBI)
Have 7 years post registration nursing experience and 3 years nursing management experience at a minimum of Clinical Nurse Manager 2 (CNM2) in an acute setting. 2 of which in an Operating Department
Have successfully completed a post registration programme of study, as certified by the education provider, which verifies that the applicant has achieved a National Framework of Qualifications (NFQ) major academic Level 8 or higher award maintained by Quality & Qualifications of Ireland (QQI)
Or Can provide written evidence from the Higher Education Institute that they have achieved the number of ECTS credits equivalent to a Level 8 or higher standard in a health care or management related area
Clinical Skills
Management skills
Leadership skills
IT skills
Quality focus
Risk Management

Job Responsibility

Provide strategic clinical and professional nursing leadership for the Operating Theatre Department (7 theatres) and CSSD, as part of the Senior Nursing Management Team, contributing to the achievement of organisational and operational performance targets
Take responsibility, in conjunction Clinical Nurse Managers, for the safe, effective, and coordinated delivery of perioperative and decontamination services, ensuring high-quality patient care across the surgical pathway
Drive a strong focus on theatre utilisation, efficiency, and performance, ensuring optimal use of theatre capacity, minimisation of downtime, and achievement of productivity goals
Lead initiatives to improve on-time starts, turnaround times, list management, and overall theatre throughput, using data and benchmarking to inform improvements
Work collaboratively with Consultants, scheduling teams, and multidisciplinary colleagues to ensure effective planning and delivery of theatre lists, balancing elective and emergency demand
Develop and implement a comprehensive workforce plan, ensuring appropriate staffing levels, skill mix, and competencies aligned with service demand
Plan, monitor, and manage human and financial resources, ensuring efficient use of staffing, including agency and bank staff
Support Clinical Nurse Managers (CNMs) and Theatre/CSSD teams in service delivery and development
Lead and participate in hospital-wide operational and service improvement initiatives
Take a lead role in clinical governance, including risk management, quality, complaints, and health & safety within perioperative services

What we offer

Competitive salary
Onsite parking
Pension
Annual bonus*
Discounted café
Sports and Social club
Employee Assistance Programme
Discounted onsite pharmacy

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 of Quality and Regulatory Affairs

The Director of Quality and Regulatory Affairs leads the global QA/RA function a...

Location

United States , Burlington

Salary:

170000.00 - 180000.00 USD / Year

Myomo

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific, technical, or related discipline
advanced degree preferred
8-10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry, including significant management experience
5+ years of experience with Class I and/or Class II medical devices
Experience operating within FDA-regulated cGMP environments, including regulatory submissions and agency interactions
Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971, and Design Controls
Experience managing Quality Management Systems (QMS) for medical devices
Experience supporting global regulatory activities (e.g., EU, Canada, APAC preferred)
Demonstrated experience leading QA/RA teams, including talent development and performance management
RAC certification or equivalent is preferred

Job Responsibility

Lead the global QA/RA function and is responsible for execution of the company’s quality and regulatory strategy
Ensure compliance with applicable global regulations and standards (including FDA and ISO requirements) and oversees quality systems across the product lifecycle
Partner cross-functionally to support product development, regulatory submissions, and ongoing compliance activities, while driving continuous improvement in quality processes
Contribute to the development and lead execution of the Quality strategy
Lead departmental planning and budgeting, optimizing resources and operational efficiency
Direct QA/RA staff, including organizational design, talent development and performance management
Develop and continuously improve quality programs, policies, and processes
Ensure Quality Management System (QMS) processes are established, implemented, and maintained
Lead regulatory activities and compliance interactions, serving as the primary liaison with regulatory authorities
Oversee development and execution of global regulatory strategies for product submissions and lifecycle management

Fulltime

Select Country

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

Audit Director, Quality & Compliance

Director of Quality

Systems Director, Population Health Service Organizations

Asset Quality Lead, Director - FSP

Director of Quality Assurance, Clinical

Assistant Director of Nursing – Theatre Department

Vice President, Risk Management

Director of Quality and Regulatory Affairs

Our AI answers in your language

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

Audit Director, Quality & Compliance

Director of Quality

Systems Director, Population Health Service Organizations

Asset Quality Lead, Director - FSP

Director of Quality Assurance, Clinical

Assistant Director of Nursing – Theatre Department

Vice President, Risk Management

Director of Quality and Regulatory Affairs

Location:
United States , Wausau

Category:
Health and Beauty

Contract Type:
Not provided

Job Posted:
December 28, 2025