Clinical Quality Manager Job at AbCellera Biologics (Montréal)

Clinical Quality Manager

Ensure implementation and oversight of the GCP Quality Management System (QMS) f...

Location

China , Shanghai

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Advanced scientific/technical degree preferred (MS/MD/PhD)
business coursework desirable
Minimum 5 years in Clinical Development Quality roles with increasing responsibility
Strong knowledge of GCP principles, clinical development process (Phases I–IV), and regulatory requirements
Project management, strategic planning, and complex decision-making skills
Excellent communication and stakeholder engagement skills (local and global)
Solid understanding of AI concepts and applications in clinical development
Ability to lead or significantly contribute to AI-driven initiatives (SSU, recruitment, eSource, etc)

Job Responsibility

Implement GCP QMS strategy locally
maintain Level 1 GCP quality documents
Ensure consistency with regulatory expectations through planning, monitoring, and continuous improvement
Act as Subject Matter Expert (SME) and point-of-contact for clinical quality requirements, promoting Quality-by-Design principles
Ensure inspection readiness and manage regulatory inspections with cross function
Serve as primary contact for audit response management as needed
Develop and execute Vendor Quality Plans
monitor vendor compliance
Drive remediation strategies for vendor quality issues and ensure timely resolution
Promote GCP quality culture across teams and vendors

Fulltime

Clinical Trial Manager/ Sr Clinical Trial Manager (PM/ Sr PM)

Clinical Operations Lead - Early Development Oncology. ICON plc is a world-leadi...

Location

United States , Raleigh, Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BS/BA degree or a relevant degree with strong emphasis on science, or equivalent experience
Minimum of five years of relevant experience in the biopharmaceutical industry or other relevant clinical research experience, with a focus on skills and competencies
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health
Prior experience in assisting the conduct and management of multinational clinical trials is preferred
Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously
Experience in oncology studies required (phase I preferred)

Job Responsibility

Participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations department
Act as preliminary liaison for study sites to convey study information, answer questions and in accordance with the escalation pathway
Develop relationships with investigational sites, HCPs, and institutions to enhance conduct of the trial
Monitor study-specific timelines and key deliverables
focus on management of all relevant external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc)
Participate as a member of the multi-disciplinary trial(s) team
Participate in coordinating efforts with internal Pharmacovigilance, and safety group as needed
Participate in data review and discrepancy resolution as needed
Assist in the development of the IP and co-medication strategy (quantities, labels, depots, tracking, etc.) working closely with other departments
Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.) as appropriate

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Manager, Quality Clinical Svc

Plans, directs, and coordinates Quality activities of a designated Clinical Cust...

Location

United States , Rockford

Salary:

77600.00 - 87300.00 USD / Year

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor's Degree in a related field and/or 7-10 years related experience and/or training
Statistical and Advanced Mathematical Skills
Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms

Job Responsibility

Select, supervise, empower, coach, develop and retain a team of qualified individuals through effective employee development, performance management, succession planning and recognition
Ensure the appropriate team structure is in place by performing workload analysis to manage headcount and to ensure we deliver on customer and business commitments
Establish quality team and individual goals and objectives in alignment with Clinical Customer Focused Team goals and customer requirements
Ensure strong alignment and coordination with other business units and functional groups. Collaborate on best practices with other Clinical Quality Managers and leadership
Facilitate the daily quality of team performance to ensure goals and objectives are met and to build a culture of safety, quality, performance, customer service and continuous improvement
Manage the training and development of the team including cross training initiatives and on-boarding of new employees to the team
Provide support for customer audits, visits and conference calls. Work with Clinical Customer Focused Team to develop systemic corrective actions to any deviations noted
Oversee investigations, consumer complaints, CAPAs, DEA activities, NMR issues, etc.
Collaborate with the other team members to manage the team performance metrics and customer scorecard
Collaborate with the appropriate Account Executive and Sr. Project Manager to coordinate and facilitate the customer Quarterly Business Review’s

What we offer

paid time off
health insurance coverage (including dental and vision)
a flexible spending account
a 401(k) plan
eligibility for an 10% annual performance bonus

Fulltime

Manager, Clinical Quality Svc

Responsible for managing daily operations of the Clinical Quality Operations and...

Location

United States , Rockford

Salary:

77600.00 - 87300.00 USD / Year

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor's Degree in a related field and/or 7-10 years related experience and/or training
Statistical and Advanced Mathematical Skills
Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms

Job Responsibility

Provide knowledge, training, leadership, motivation, and guidance to ensure staff have a clear understanding of tasks, responsibilities, business goals and customer demands
Provide 24-hour support for Quality related issues either by phone or email
Be observant of processes, performance, and behaviors, focusing on continuous improvement
Manage budgets and plans for business growth
Compile, analyze and report key departmental Quality metrics (Product HOLDs, Line Clearance Observations/Failures, Near Miss events and Right First Time metrics)
Provide support via emails, phone, conference calls, Quarterly Business Review/meetings, tours, audits and investigations
Perform and participate in tours of functional areas for internal, customer and regulatory audits. Identify risks, observations, and controls. Communicate results and develop action plans to resolve issues
Ensure Quality issues are resolved appropriately and report results to Quality and Production Management
Oversee incoming, in-process and finished goods inspections of products to ensure conformance to established standards
Investigate root causes of quality events/defects and recommending solutions

What we offer

paid time off
health insurance coverage (including dental and vision)
a flexible spending account
a 401(k) plan
eligibility for an annual performance bonus

Fulltime

R&D Clinical - Quality Compliance Senior Manager

We are hiring a R&D Clinical Quality Compliance Senior Manager, who will operate...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s Degree in appropriate discipline e.g. Life Sciences, Medical
15-18 years’ experience working in Biotech, Pharmaceutical or CRO company
In-depth knowledge of ICH GCP
Extensive experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are core responsibilities
Experience using electronic QMS such as Veeva Vault and eTMF
Experience and understanding of Clinical R&D activities and Global Regulations
In-depth knowledge of the Regulatory Submission and Inspection readiness, preparation and management procedures
Extensive experience in Quality Oversight of Clinical Trials, including clinical trial protocol development and execution
Strong verbal and written communication skills, including strong business writing abilities and active listening
Strong analytical, critical-thinking, and decision-making abilities

Job Responsibility

Key advisor to the study team throughout the clinical trial life cycle, providing independent and objective quality input in the areas of GCP and compliance with Amgen SOPs and processes
Review and provide input into the development of the initial clinical study protocol and subsequent amendments, with focus on quality by design, confirming it’s fit for purpose, clear, concise and consistent
Actively provide input into study risk assessment activities
Review and provide input into other key study documents and plans
Direct study teams through the management of complex quality issues
Participate in key activities related to Risk Based Quality Management
Using available tools, analyze quality data metrics
Monthly meetings with study team lead/associate director, to review the following: on-going quality issues, quality trends, program filing timelines, inspection readiness, potential inspections and audit scheduling and planning and any other topics deemed relevant
Support the clinical study team with inspection readiness activities
Support continuous improvement initiatives within TA Quality

What we offer

Varied opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Fulltime

Clinical Risk and Quality Manager

The Clinical Risk and Quality Manager (CRQM) is responsible for managing the dev...

Location

Ireland , Galway or Dublin

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

RCN qualified
Minimum of 7-10 years’ clinical experience in hospital and/or community care
Experience in legislative / regulatory compliance, quality assurance and risk management
Skilled in identifying, collecting, collating and analysing data
Able to evaluate complex information and confidently make decisions in a timely manner
Excellent communication and organisational skills, with strong attention to detail
Able to develop, manage and lead staff
Capable of prioritising and handling multiple tasks with deadlines
Excellent IT skills
Full driving licence

Job Responsibility

Maintain and develop the Paediatric Care division’s clinical governance framework
Ensure that a robust risk management process is maintained
Identify, manage, report on and address operational and clinical risks
Have input into care planning, reporting and ongoing clinical management
Keep up-to-date and monitor compliance with relevant legislation, standards and regulation
Ensure clinical policies and procedures reflect best practice
Take responsibility for the management of clinical audits
Have input into the development and management of the company’s training programmes
Develop an annual Paediatric Care Services Strategy
Develop and present key KPI reporting and metrics

Fulltime

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

Sr. Quality Specialist, Clinical Quality

Baptist Health is hiring a Sr. Quality Specialist to join the Quality team. This...

Location

United States , Jacksonville Beach

Salary:

Not provided

Baptist Health (Florida)

Expiration Date

Until further notice

Requirements

Bachelor's Degree - Nursing
3-5 Years Clinical Nursing Experience Required
1-2 years Healthcare Quality Required
Basic Life Support (BLS) Required
Licensed Registered Nurse Required
Must be a registered nurse

Job Responsibility

Oversees and/or works in tandem with facility-based quality improvement program team and leaders
Establishes facility quality procedures, standards, and specifications
assesses needs and compliance
Advances novice quality team members to proficient quality team leaders through ongoing mentorship, communication, and support
Aligns with the National Association of Healthcare Quality's 8 domains for healthcare quality competency
Actively engages in healthcare quality development through competence and continued learning
Collaborates with Facility Leaders to promote and incorporate healthcare quality objectives into the strategic operating practices through professional communication and relationship building
Interacts and establishes relationships with System Leadership and Boards in partnership with Advanced Quality Team Members
Adopts and utilizes performance improvement frameworks and methodologies to lead projects and change management at the local facility level
Begins leading and/or co-leading projects and/or committees at the healthcare system level

Fulltime

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Clinical Quality Manager

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