Clinical Quality Manager Job at AbCellera Biologics (Montréal)

Program Manager Clinical Risk Management and Patient Safety - Quality Management

This role also works in conjunction with the System Director of Clinical Risk Ma...

Location

United States , Tyler

Salary:

Not provided

CHRISTUS Health

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in healthcare-related field required
5 years of healthcare risk management experience required
Proficiency with Microsoft Word, Excel, and PowerPoint required
Certified Professional in Patient Safety (CPPS) or Certified Professional in Healthcare Risk Management (CPHRM) required within 1 year of hire

Job Responsibility

Assists in identifying and evaluating activities or events occurring within the system and facilities, which may affect patient safety, resulting in either patient injury and/ or a potential opportunity to improve care delivery and patient safety
Facilitates implementation and management of a system clinical adverse event investigation process and provides consultation to facility and system staff
Provides leadership for conducting patient safety/ clinical risk assessments and adverse event investigations including root cause analyses and implementation of effective corrective action plans
Demonstrates a high degree of professionalism and communication skills when working with staff involved in adverse events, promoting a culture of no blame and collaboration
Facilitates, tracks, and maintains appropriate records and metrics regarding adverse events and potential for patient and staff safety issues
Uses data and trend analysis experience to facilitate system efforts to analyze data including metrics, surveys, occurrence reports, adverse event investigations, FMEAs, and other information to identify and prioritize clinical risk management/ loss prevention, and patient and staff safety concerns
Supports and contributes to system efforts to carry out FMEAs regarding clinical risk management/ loss prevention, as well as patient and staff safety concerns
Carry out other duties as assigned by leadership
Strive to increase and share current knowledge in the areas of clinical risk management and patient and staff safety
Possesses excellent organizational and analytical skills

Fulltime

Manager Quality Management

In a High- Reliability Organization, the Manager Quality Management, reporting t...

Location

United States , Mamou

Salary:

Not provided

CHRISTUS Health

Expiration Date

Until further notice

Requirements

Bachelor’s degree of Science in Nursing or other related field required
Three years of healthcare experience
Two years of quality management experience
CPHQ (Certified Professional in Healthcare Quality) preferred upon hire or within 2 years
Master’s degree preferred
Proficient in computer skills using EXCEL, PowerPoint, MS Office, and Flowchart tools
Knowledgeable on High-Reliability Principles and PDSA methodology

Job Responsibility

Support of the quality management program throughout the hospitals
Facilitation of continual regulatory preparedness
Management of specialized QM projects
Mastery of the PDSA project life cycle
Managing teams to the desired objective
Applying clinical knowledge and analytical skills to assist the Director of QM and leadership in identifying opportunities, develop solutions, and implement changes with a strong focus on improving quality outcomes and results
Communicate effectively to different audiences
Quality Leadership and Integration
Performance and Process Improvement
Population Health and Care Transitions

Fulltime

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Quality Compliance Manager

The Quality Compliance Manager will lead the implementation of a customized, ris...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.)
Minimum 5 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards
2 years or more 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 TrackWise
Thorough understanding of Clinical R&D activities and Global/local Regulations
Knowledge of Regulatory Submission and local/Foreign Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
Excellent verbal and written communication skills, including strong business writing abilities and active listening
Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format
Strong analytical, critical-thinking, and decision-making abilities

Job Responsibility

Review clinical trial protocols to ensure simplification, integration of lessons learned, and identification of critical data and processes
Provide quality oversight by assessing trial risks using the Risk Assessment Categorization Tool (RACT), ensuring accurate prioritization and mitigation of risks to patient safety, data integrity, and regulatory compliance—including country-specific risks relevant to Taiwan
Lead the development and implementation of Taiwan-specific Quality Plans, establishing local expertise to ensure adherence to applicable regulations
Collaborate with Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarkers, imaging)
Contribute to the design and execution of TA and affiliate-specific Quality Assurance plans, including audit strategies (e.g., investigator site, affiliate, and study-level audits)
Support local clinical trial and cross-functional teams in managing quality activities such as issue resolution (e.g., deviations, CAPAs, serious breaches, privacy concerns), inspection readiness, and audit/inspection management
Monitor, analyze, and report compliance metrics and trends to key stakeholders and senior leadership, providing actionable recommendations
Drive innovation by exploring and applying sophisticated quality oversight methodologies, including AI, Natural Language Processing (NLP), and data analytics

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Clinical Services Manager

The Clinical Services Manager (Regulatory and Quality Compliance Lead) will play...

Location

United Kingdom , Edgbaston or Glasgow

Salary:

55000.00 - 65000.00 GBP / Year

ACES Eye Clinic

Expiration Date

Until further notice

Requirements

Registered Healthcare Professional (NMC, HCPC, or equivalent)
Significant experience in clinical governance, regulatory compliance, or healthcare quality management
Strong understanding of CQC and UK regulatory frameworks, inspection preparation, and application processes
Skilled in data analysis, audit management, and quality reporting
Excellent communicator with the ability to engage confidently at senior and regulatory levels
Proactive, analytical, and organised, with a commitment to clinical excellence and patient safety

Job Responsibility

Lead on regulatory submissions, applications, and notifications to CQC and other UK regulators
Oversee governance administration, including Clinical Governance and Quality Committee meetings
Maintain and analyse the Quality and Compliance Dashboard to monitor clinical performance
Manage and report on incidents, complaints, investigations, and patient safety outcomes
Support and oversee compliance with mandatory training, clinical audits, and quality improvement plans
Undertake regular mock inspections and oversee our regulatory readiness framework
Liaise with commissioners, regulators, and internal stakeholders on matters of quality and compliance
Prepare comprehensive reports for the Director of Care and Quality and the Executive Team
Provide leadership and support to the Clinical Services Quality Team, promoting a culture of accountability and continuous improvement

What we offer

29 Days Annual leave
Private Medical Insurance
Free Eye surgery (LVC or IOL)
Discounts on other group procedures and goods

Fulltime

Quality Management Specialist

We are providing a contract for a fulltime employment opportunity for a Quality ...

Location

United States , Oakland

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Possess strong management skills with the ability to oversee multiple tasks simultaneously
Proficiency in reporting and analytics, with a keen eye for data analysis and metric reporting
Demonstrated experience in strategic planning and implementation
Familiarity with drafting, interpreting, and implementing procedures and policies
Solid understanding of quality design and optimization principles
Knowledge in project management and the ability to handle multiple projects simultaneously
Excellent presentation skills with the ability to communicate complex information effectively
Must provide medical coverage knowledge and demonstrate understanding of clinical trial operations
Strong leadership skills, with the ability to inspire and motivate a team
Consulting experience, with the ability to provide expert advice and guidance

Job Responsibility

Lead the planning, coordination, and monitoring of clinical care and outcomes improvement strategies
Coach and consult individuals, departments, and multi-disciplinary teams on quality improvement processes and tools
Analyze existing care delivery models to identify opportunities for systems-based improvements
Oversee reporting requirements, establish guiding metrics, and benchmarks for performance improvement initiatives
Collaborate with medical information teams to design safe, high-quality workflows
Develop presentations to disseminate information and updates on improvement strategies
Facilitate and sustain performance improvement initiatives and activities in the healthcare setting
Ensure compliance with regulatory and accrediting agency requirements, maintaining a focus on data integrity, integration, and standardization
Assist in evaluating current and future quality initiatives within the health system
Advocate for best practices in patient safety, quality, and patient experience within the organization

What we offer

medical, vision, dental, and life and disability insurance
eligible to enroll in our company 401(k) plan

Fulltime

Clinical Services Manager

The Clinical Services Manager (Regulatory and Quality Compliance Lead) will play...

Location

United Kingdom , Glasgow; Edgbaston

Salary:

55000.00 - 65000.00 GBP / Year

ACES Eye Clinic

Expiration Date

Until further notice

Requirements

Registered Healthcare Professional (NMC, HCPC, or equivalent)
Significant experience in clinical governance, regulatory compliance, or healthcare quality management
Strong understanding of CQC and UK regulatory frameworks, inspection preparation, and application processes
Skilled in data analysis, audit management, and quality reporting
Excellent communicator with the ability to engage confidently at senior and regulatory levels
Proactive, analytical, and organised, with a commitment to clinical excellence and patient safety

Job Responsibility

Lead on regulatory submissions, applications, and notifications to CQC and other UK regulators
Oversee governance administration, including Clinical Governance and Quality Committee meetings
Maintain and analyse the Quality and Compliance Dashboard to monitor clinical performance
Manage and report on incidents, complaints, investigations, and patient safety outcomes
Support and oversee compliance with mandatory training, clinical audits, and quality improvement plans
Undertake regular mock inspections and oversee our regulatory readiness framework
Liaise with commissioners, regulators, and internal stakeholders on matters of quality and compliance
Prepare comprehensive reports for the Director of Care and Quality and the Executive Team
Provide leadership and support to the Clinical Services Quality Team, promoting a culture of accountability and continuous improvement

What we offer

29 Days Annual leave
Private Medical Insurance
Free Eye surgery (LVC or IOL)
Discounts on other group procedures and goods

Fulltime

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree with 25+ years of data management experience
10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
Understanding of clinical data standards (CDISC, SDTM, ADaM)
Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams

Job Responsibility

Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data

Clinical Quality Manager

AbCellera Biologics

Location:
Canada , Montréal ▼
Vancouver

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 20, 2026

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