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Full-time
bachelor degree
Competitive base salary, Performance related incentives, Medical coverage, Dental coverage, Vision coverage, Retirement and pension plans
Posted 2d ago
~40 hrs/week
Remote in Warsaw, Masovian Voivodeship, Poland
Responsibilities
The Clinical Quality Associate Director provides quality and compliance expertise to local study teams while driving risk management and audit readiness. They also lead operational improvement initiatives and act as a primary interface between Quality Assurance and Clinical Operations.
Requirements
Candidates must have a Bachelor's degree in a relevant discipline and significant experience in the pharmaceutical industry, specifically in clinical research or quality assurance. Strong knowledge of GxP requirements, ICH-GCP, and clinical trial regulations is essential for this role.
Full job description
Clinical Quality Associate Director
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
We are committed to pushing the boundaries of science to deliver life-changing medicines. As a Clinical Quality Associate Director (CQAD), you will play a pivotal role in ensuring clinical studies are delivered to the highest standards of quality, compliance and integrity.
Working closely with local Site Management & Monitoring (SMM) leadership and collaborating across regional and global teams, you will act as a trusted quality and compliance advisor. You will help teams navigate complex regulatory requirements, strengthen quality processes, manage risk and continuously improve the way clinical trials are delivered.
This is a highly influential role for someone who enjoys working across functions, solving complex problems and translating quality and regulatory requirements into practical solutions.
As Clinical Quality Associate Director, you will:
Provide quality and compliance expertise to local study teams, advising on company procedures, ICH-GCP, industry standards and applicable local regulations.
Monitor the regulatory landscape, ensuring clinical operations teams are kept informed of changes that may impact compliance or study delivery.
Drive quality oversight and risk management, supporting the planning and execution of local Quality Control activities and identifying opportunities to mitigate compliance risks.
Support audit and inspection readiness, including preparation, execution, response and follow-up activities, acting as a key local contact for auditors and inspectors.
Guide teams in addressing audit and inspection findings and support the development and implementation of effective corrective and preventive actions.
Promote continuous learning by sharing audit and inspection insights locally and across regional quality networks, while bringing global and regional best practices to local teams.
Identify and address training needs, coordinating or delivering training for SMM colleagues and, where appropriate, investigational site staff.
Support the implementation of global procedures and systems by providing local expertise, feedback and guidance and escalating relevant issues to regional and global stakeholders.
Lead or contribute to quality and operational improvement initiatives, including the implementation of systems, tools, SOPs and processes that support compliant and efficient clinical trial delivery.
Oversee local procedural documents, ensuring they are developed, maintained, trained and archived in alignment with global processes, ICH-GCP and local regulations.
Act as the primary local interface for Quality Assurance, building strong relationships with Quality, Clinical Operations and other R&D functions.
Contribute to regional and global quality networks, sharing expertise, best practices and lessons learned.
Provide expert regulatory and quality input to other departments and represent the organization in relevant professional, regulatory and operational forums.
Support the evaluation and management of potential fraud or misconduct cases, working with Quality Assurance, regional quality leadership and local management as appropriate.
#LI-MC1
What you’ll bring
We’re looking for an experienced clinical research or quality professional who can combine strong technical expertise with excellent influencing and communication skills.
You will ideally have:
A Bachelor’s degree in a relevant discipline, preferably Life Sciences, or an equivalent qualification.
Previous experience within the pharmaceutical industry, ideally across Clinical Operations, Quality Assurance or a related clinical research function.
Strong knowledge of the drug development process and GxP requirements, including ICH-GCP and applicable clinical trial regulations.
Experience with clinical study operations, including monitoring, study drug management, data management and clinical quality oversight.
Experience supporting or leading audit and regulatory inspection readiness and activities.
Strong understanding of quality management, risk-based thinking, process management and continuous improvement.
The ability to interpret complex regulatory and procedural requirements and translate them into practical guidance for operational teams.
Excellent written and spoken business-level English.
Strong communication, influencing, training and workshop facilitation skills.
Excellent problem-solving, critical thinking, decision-making and issue-management capabilities.
The ability to build trusted relationships and influence stakeholders across functions, cultures and organisational levels.
A proactive approach to identifying opportunities to improve the quality, efficiency, cost and speed of clinical trial delivery.
The ability to work effectively across both in-person and virtual environments.
A high level of integrity, accountability and ethical judgement.
Willingness and ability to travel nationally and internationally as required.
A valid driving license, where required by local employment regulations.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
Medical DeviceTherapeuticsGovernment and Public Health SolutionsClinical Research ServicesCommercialisation and OutcomesOncologyValue Based HealthcareClinical TrialsPatient RecruitmentInnovation
How many Science & Research jobs are open in Gdansk, Poland right now?
There are currently 38 open science & research positions in Gdansk, Poland listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Gdansk, Poland?
Companies currently hiring include Lyten, ICON plc, Intel, LEO Pharma, Accenture, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Gdansk, Poland?
Yes — 19 of the 38 open science & research positions offer remote or hybrid work (12 remote, 7 hybrid).
How do I apply for Science & Research jobs in Gdansk, Poland?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.