CrawlJobs Logo

Clinical Audit and Quality Lead

psychiatry-uk.com Logo

Psychiatry UK

Location Icon

Location:
United Kingdom

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

The Clinical Audit and Quality Lead plays a key role in supporting the quality team to ensure compliance with regulatory frameworks and governance standards across all services. The role involves leading and conducting clinical audits, advising operational and clinical teams, and promoting best practice to drive continuous improvement. The postholder will work closely with leadership and frontline colleagues to maintain healthy governance, identify early signs of risk, and implement proactive measures to enhance safety and quality. This includes fostering a culture of openness, person-centred care, and positive learning, while embedding quality as a core responsibility throughout the organisation.

Job Responsibility:

  • Ensure all services meet statutory and regulatory requirements, working towards regulator goals and ambitions, and provide targeted support to maintain compliance
  • Promote a culture of Outstanding care, openness, responsiveness, person-centred recovery, positive learning, and safety, embedding quality as a daily responsibility for all staff
  • Lead and support audits, mock inspections, and peer reviews to identify trends, risks, and improvement opportunities, using findings to drive continuous improvement and best practice
  • Provide advice, guidance, and practical support to operational teams, managers, and quality colleagues, acting as a role model and maintaining accessibility to service users and families
  • Collaborate with governance teams and stakeholders (e.g., CQC, NHS bodies) to maintain robust systems, policies, and relationships, and contribute to service improvement plans and quality strategies
  • Analyse data and intelligence to identify themes, develop improvement plans, and report findings
  • deliver training and support safeguarding, QI initiatives, and patient safety investigations
  • Produce clear, accurate audit reports and escalate where required. Provide feedback on quality performance to the senior clinical audit and quality lead or Head of clinical audit & quality
  • Support implementation and maintenance of systems (e.g., EPR, RADAR) and promote service user involvement in quality and safety developments
  • Support the Head of Clinical Audit & Quality in projects and tasks that align with the Quality strategy, including Internal Reviews
  • Maintain accurate and up-to-date records of audit activity and outcomes
  • Support and advise clinical audit champions and staff involved in audit activity
  • Promote engagement in clinical audit and quality improvement across services

Requirements:

  • Experience working in clinical audit, quality, governance, or service improvement
  • Strong knowledge of regulatory and compliance requirements, relevant legislation, and national health and social care policies
  • Professional qualification or equivalent experience in quality-related roles, with sound understanding of the clinical audit cycle and quality improvement principles
  • Understanding of best practice, national standards, and guidelines
  • Strong problem-solving, analytical, and report-writing skills
  • Ability to manage and deliver audits independently with appropriate support
What we offer:
  • Health Cash Plan
  • Well Hub Subscription
  • access to an Employee Assistance Programme
  • Annual Volunteering Day
  • Enhanced Sickness and Family Leave pay
  • Length of Service Bonus
  • Work from Home allowance
  • Pension options

Additional Information:

Job Posted:
January 24, 2026

Expiration:
February 05, 2026

Employment Type:
Fulltime
Work Type:
Remote work
Job Link Share:

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

Briefcase Icon

Similar Jobs for Clinical Audit and Quality Lead

Audit Director, Quality & Compliance

The Audit Director is responsible for leading the strategy, execution, and conti...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • health and retirement, PTO, and stock option plans
Read More
Arrow Right

Theatre Quality Lead

The Theatre Quality Lead (CNM2) promotes, facilitates and supports the provision...
Location
Location
Ireland , Dublin
Salary
Salary:
Not provided
hermitageclinic.ie Logo
Blackrock Health Hermitage Clinic
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Be registered in the general division of the Register of Nurses maintained by NMBI
  • Have at least five years recent relevant post-registration nursing experience (full-time or equivalent hours part-time) in an acute hospital setting and a minimum of two years nursing experience in Theatre nursing
  • Have a recognised post-registration nursing course - Higher Diploma or Post Graduate appropriate to the position is essential i.e. Quality, or in pursuit of same
  • Proven clinical and professional management, risk management and clinical audit ability
  • Quality focus
  • Excellent interpersonal and communication skills
  • Management skills
  • Leadership skills
  • Negotiating Skills
  • Risk Management
Job Responsibility
Job Responsibility
  • Ensure compliance with all relevant Blackrock Health Hermitage Clinic guidelines, policies, procedures and relevant legislation and regulatory requirements
  • Encourage continuous review and evaluation of policies, guidelines and existing practices through regular audit programmes and review
  • Promote a culture of continuous quality improvement across the Operating Theatre Department
  • Set and monitor core objectives, standards and key performance indicators for the service
  • Lead out on the requirements of the hospital’s accreditation process
  • Ensure the department’s readiness for HIQA inspections
  • Participate fully in the requirement of the hospital’s risk management programme
  • Promote the delivery of a high standard of care to all patients
  • Work with members of the multidisciplinary team in devising Standard Operating Procedures
  • Provide clinical nursing leadership in proactively addressing ethical and quality of services issues
  • Fulltime
Read More
Arrow Right

GCP Quality Auditor

In this vital role within R&D Quality you will be planning and participating in ...
Location
Location
United Kingdom , Uxbridge; London; Edinburgh; Cambridge; Aberdeen
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree educated
  • Proven and extensive international auditing experience in GCP
  • Experience of data mining, manipulation and data analytics would be advantageous
  • Excellent written and verbal communication skills
Job Responsibility
Job Responsibility
  • Plan, conduct and report routine and directed GCP compliance audits internationally
  • Serve as a lead auditor for complex GCP audits
  • Identify and communicate compliance risks to R&D Quality management
  • Host and/or play a role in regulatory authority inspections
  • Contribute to or lead R&D Quality process improvement initiatives
  • Author and contribute to the development of R&D Quality cross functional controlled documents
What we offer
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
Read More
Arrow Right

Clinical Auditor

The key purpose of this role is to lead and conduct clinical audits, with the ai...
Location
Location
Ireland
Salary
Salary:
Not provided
hermitageclinic.ie Logo
Blackrock Health Hermitage Clinic
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Clinical background is essential
  • Qualification in auditing is desirable
  • Experience with IT / administration systems
  • Experience in a Quality/ Healthcare environment desirable
  • Experience working on own initiative and with multidisciplinary stakeholders
  • Ability to communicate appropriately and effectively with colleagues and other members of staff
  • Excellent organisation skills and ability to multitask and work under pressure
  • Excellent problem-solving skills and positive attitude towards challenging situations
  • Meticulous and strong attention to detail
  • Integrity and reliability paramount
Job Responsibility
Job Responsibility
  • Lead and conduct clinical audits to identify gaps and recommend changes to clinical practices
  • Coordinate and manage clinical audits to ensure healthcare organisations follow proper procedures and protocols
  • Check compliance with evidence based best practice
  • Collate and analyse data in conjunction with the quality team and prepare audit data for various committees and stakeholders
  • Identify areas of improvement within the organisation
  • Conduct clinical audits including reviewing charts, other documentation, and observation of practice
  • Liaise with the Quality and Risk Manager to set up audit schedules and review current audit frameworks
  • Facilitate clinical audit work across the organisation
  • Provide advice guidance and support to staff undertaking clinical audit projects
  • Ensure that audits comply with the principles of good practice
What we offer
What we offer
  • Competitive salary
  • Onsite parking
  • Pension
  • Discounted café
  • Sports and Social club
  • Employee Assistance Programme
  • Discounted onsite pharmacy
  • Fulltime
Read More
Arrow Right

Quality Coordinator

The key purpose this role is to lead and conduct clinical audits, with the aim o...
Location
Location
Ireland
Salary
Salary:
Not provided
hermitageclinic.ie Logo
Blackrock Health Hermitage Clinic
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Clinical background is essential
  • Qualification in auditing is desirable
  • Experience with IT / administration systems
  • Experience in a Quality/ Healthcare environment desirable
  • Experience working on own initiative and with multidisciplinary stakeholders
  • It is essential that you have valid work permission for the Republic of Ireland to take up employment for this position, or in the case of critical skills, you must be eligible for a work permit.
Job Responsibility
Job Responsibility
  • To conduct clinical audits including but not limited to reviewing charts, other documentation, and observation of practice
  • Liaise with the Quality and Risk Manager to set up audit schedules and review current audit frameworks
  • To facilitate clinical audit work across the organisation
  • Provide advice guidance and support to staff undertaking clinical audit projects
  • Ensuring that audits comply with the principles of good practice
  • To work closely with hospital departments in conjunction with the Quality team to provide reports and feedback on audits conducted
  • Develop an audit and monitor compliance
  • Validate auditors in line with hospital policy and JCI /HIQA requirements
  • Review patient records or other data sources and accurately and completely record information in accordance with the audit design and protocols
  • Maintain strict confidentiality in relation to patient identifiable information
What we offer
What we offer
  • Competitive salary
  • Pension
  • Discounted café
  • Sports and Social club
  • Employee Assistance Programme
  • Discounted onsite pharmacy
  • Fulltime
Read More
Arrow Right

General Manager Clinical Governance

The General Manager Clinical Governance provides enterprise-wide clinical leader...
Location
Location
Australia , St Leonards
Salary
Salary:
Not provided
https://www.hammond.com.au/ Logo
HammondCare
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Current AHPRA registration and tertiary qualifications in Nursing (Bachelor of Nursing or equivalent)
  • At least 5+ years demonstrated in a Senior Nursing role, preferably in aged care, dementia, palliative care, older persons’ mental health, or related fields
  • Extensive knowledge of clinical governance, quality systems, and accreditation frameworks
  • Demonstrated leadership in building clinical capability and systems
  • Expertise in analysing complex clinical and operational data
  • Strong communication, influencing, and report writing skills
  • Postgraduate qualification in Clinical Practice, Clinical Governance, Health Administration, Public Health, or Business Administration (or working towards) desirable
  • Research and publication experience in relevant fields desirable
Job Responsibility
Job Responsibility
  • Develop and lead the enterprise Clinical Governance Strategy to underpin safe, high-quality, person-centred care
  • Chair the Clinical Governance Committee and Quality Care Advisory Body
  • Support the Board Quality, Safety, and Care Sub-Committee with expert clinical advice
  • Ensure enterprise-wide integration of clinical policies, audit systems, and governance structure
  • Influence organisational decision-making with high-level medical expertise
  • Set, monitor, and report on clinical performance targets aligned with standards (e.g., NACMQI, Strengthened Quality Standards)
  • Leverage data and business intelligence to identify risks, gaps, and drive continuous quality improvement
  • Lead incident management, risk mitigation, and clinical investigations where required
  • Lead and nurture a Clinical Community of Practice across HammondCare services
  • Mentor and develop clinical leaders, building a future-ready clinical workforce
What we offer
What we offer
  • NFP salary packaging ($15,900 tax free) plus meals and entertainment benefit (up to $2,650 tax free)
  • Additional leave purchase options and 14 weeks paid parental leave
  • Flexible working options, including hybrid arrangements
  • Discounts on everyday products and services
  • Discounted healthcare memberships - access to network of fitness centres and pools for employees and families
  • Free independent, confidential counselling services, wellbeing resources and webinars available through our Employee Assistance Program (EAP) for you and your family
  • Health & Wellbeing programmes
  • Reward & Recognition programmes
  • Referral bonuses
  • Career and professional development opportunities
  • Fulltime
Read More
Arrow Right

Director of Quality Assurance, Clinical

Responsible for leading in the development, implementation and maintenance of QA...
Location
Location
United States , Berkeley
Salary
Salary:
220000.00 - 235000.00 USD / Year
cariboubio.com Logo
Caribou Biosciences
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Quality Compliance Manager

The Quality Compliance Manager will lead the implementation of a customized, ris...
Location
Location
Taiwan , Taipei
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right