Senior Clinical Quality Assurance Manager
Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.
Role Objectives:
The Senior Clinical Quality Assurance Manager at WEP Clinical oversees the maintenance and compliance of the Quality Management System, ensuring adherence to quality principles and Good Clinical Practice (GCP) regulatory requirements. This role supports key stakeholders across global clinical operations, including clinical trial management and the patient-enabling solutions group, which encompasses home health solutions, virtual clinical trials, patient concierge services, and patient recruitment. Additionally, the Senior Clinical Quality Assurance Manager is responsible for developing, implementing, and maintaining quality assurance standards and processes to uphold the safety, efficacy, and ethical conduct of clinical trials in compliance with GCP.
The Ideal Candidate:
Decisive and strategic leader
Adaptable and solution-oriented
Detail Oriented and analytical
Strong interpersonal skills
What You'll Do:
Develop, implement, and maintain a comprehensive quality assurance framework for clinical services, ensuring compliance with GCP, FDA, EMA, and internal standards
Manage quality records and processes, including deviations, change controls, CAPAs, complaints, and other quality incidents
Conduct risk assessments to identify and mitigate potential quality risks in nursing and clinical services
Perform audits and inspections to assess compliance, identify non-conformances, and implement corrective actions
Host external client and regulatory inspections, coordinating audits and responses
Monitor, develop, and deliver training on quality assurance principles, regulatory requirements, and SOPs
Oversee external vendors to ensure compliance with quality standards and regulatory requirements
Ensure compliance with regulatory requirements, including GCP, data privacy laws (e.g., GDPR), and local regulations
Identify and implement process improvements to enhance the quality and efficiency of clinical services and home health solutions
Serve as the key quality contact for projects, supporting setup and liaising with clients as needed
What You'll Need:
Bachelor’s degree or higher, preferably in pharmaceutical sciences, life sciences, or nursing
7+ years of experience in clinical research with a focus on quality assurance and/or clinical services
In-depth knowledge of clinical trial methodologies, regulatory requirements, and GCP guidelines
Experience with decentralized clinical trials and remote patient monitoring is a plus
Demonstrated expertise in developing and implementing quality assurance systems, change management, and processes
What We Offer:
Private healthcare insurance
Long-term illness Cover
Death in service cover
Salary sacrifice pension
Annual leave
Paid maternity & paternity leave
Volunteer day
What Sets Us Apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.
We're Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
About the job
Apply for this position
Senior Clinical Quality Assurance Manager
Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.
Role Objectives:
The Senior Clinical Quality Assurance Manager at WEP Clinical oversees the maintenance and compliance of the Quality Management System, ensuring adherence to quality principles and Good Clinical Practice (GCP) regulatory requirements. This role supports key stakeholders across global clinical operations, including clinical trial management and the patient-enabling solutions group, which encompasses home health solutions, virtual clinical trials, patient concierge services, and patient recruitment. Additionally, the Senior Clinical Quality Assurance Manager is responsible for developing, implementing, and maintaining quality assurance standards and processes to uphold the safety, efficacy, and ethical conduct of clinical trials in compliance with GCP.
The Ideal Candidate:
Decisive and strategic leader
Adaptable and solution-oriented
Detail Oriented and analytical
Strong interpersonal skills
What You'll Do:
Develop, implement, and maintain a comprehensive quality assurance framework for clinical services, ensuring compliance with GCP, FDA, EMA, and internal standards
Manage quality records and processes, including deviations, change controls, CAPAs, complaints, and other quality incidents
Conduct risk assessments to identify and mitigate potential quality risks in nursing and clinical services
Perform audits and inspections to assess compliance, identify non-conformances, and implement corrective actions
Host external client and regulatory inspections, coordinating audits and responses
Monitor, develop, and deliver training on quality assurance principles, regulatory requirements, and SOPs
Oversee external vendors to ensure compliance with quality standards and regulatory requirements
Ensure compliance with regulatory requirements, including GCP, data privacy laws (e.g., GDPR), and local regulations
Identify and implement process improvements to enhance the quality and efficiency of clinical services and home health solutions
Serve as the key quality contact for projects, supporting setup and liaising with clients as needed
What You'll Need:
Bachelor’s degree or higher, preferably in pharmaceutical sciences, life sciences, or nursing
7+ years of experience in clinical research with a focus on quality assurance and/or clinical services
In-depth knowledge of clinical trial methodologies, regulatory requirements, and GCP guidelines
Experience with decentralized clinical trials and remote patient monitoring is a plus
Demonstrated expertise in developing and implementing quality assurance systems, change management, and processes
What We Offer:
Private healthcare insurance
Long-term illness Cover
Death in service cover
Salary sacrifice pension
Annual leave
Paid maternity & paternity leave
Volunteer day
What Sets Us Apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.
We're Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.