* Industry Pharma/Biotech/Clinical Research
* Remote Job
Job Description
This is a remote position.
About Arriello:
At Arriello, we provide a full range of Pharmacovigilance, Quality & Compliance, and Regulatory Affairs services to global pharmaceutical and life sciences companies. With a team of experienced professionals, we support our clients in meeting their regulatory obligations, maintaining product quality and patient safety, and navigating complex global compliance landscapes.
As a growing business with a dynamic culture, we are committed to high-quality delivery, continuous improvement, and creating an environment where people can thrive.
At Arriello, our values define how we work — and who we are:
Inclusive - We value equity, inclusion and dignity for all, recognising that we learn from each other every day.
Dedicated - We challenge the status quo to deliver pragmatic, tailored solutions for our clients.
Innovative - We collaborate closely—with our clients, colleagues and partners—to proactively find better ways forward.
Passionate - We build strong relationships based on empathy, respect and a genuine commitment to delivering quality in everything we do.
The opportunity
We are seeking an experienced Quality and Compliance Manager with strong internal and external auditing experience, extensive Good Pharmacovigilance Practice knowledge, and proven capability working within regulated pharmaceutical, biotech, or clinical research settings.
Experience within consultancy or Contract Research Organisation environments is a strong advantage, as this position combines internal Quality Management System responsibilities with high-impact client-facing work.
This role suits someone who is confident in audits, investigations, and continuous improvement, and who enjoys shaping quality culture both internally and for clients.
This is a remote role, based in the Czech Republic, Croatia, or Romania
What you will do
Audit Leadership
* Lead and perform internal and external audits across clinical, vendor, and Quality Management System processes.
* Conduct Good Pharmacovigilance Practice and wider Good Practice audits on behalf of clients.
* Prepare audit plans, execute audits, prepare reports, and ensure timely closure of findings.
* Provide peer review of audit documentation prepared by colleagues and support audit readiness.
Quality Management System Oversight
* Maintain and continuously improve the Quality Management System, ensuring alignment with regulatory expectations and best practice.
* Manage Quality Management System tools and workflows, ensuring accuracy, traceability, and effective data management.
* Contribute to the development and maintenance of Quality Management System procedures, job aids, templates, and training materials.
* Support health authority inspection preparation, documentation, and responses.
Deviation and CAPA Management
* Lead or oversee root cause investigations into deviations, non-conformances, complaints, and audit findings.
* Implement robust corrective and preventive actions and track their effectiveness.
* Support device vigilance, complaint handling processes, and quality metrics reporting.
Process Improvement and Risk Management
* Identify and implement improvements across quality processes, systems, and documentation.
* Work with cross-functional teams to assess quality risks and develop appropriate mitigation strategies.
* Ensure processes reflect current industry standards and regulatory guidance.
Client Support and Consultancy Delivery
* Deliver Quality and Compliance services to clients and present recommendations clearly and confidently.
* Build strong client relationships and support business development discussions where helpful.
* Manage time, budgets, and deliverables to a consistently high standard.
Leadership and Collaboration
* Provide training, mentoring, and support to colleagues within the Quality and Compliance function.
* Work cross-functionally with operational teams to promote high standards of quality and compliance.
* Represent Arriello professionally at meetings, inspections, and industry events.
Requirements
* A degree in a relevant scientific or healthcare discipline such as quality management, regulatory affairs, chemistry, biology, or engineering.
* 5+ years proven experience in quality compliance or quality assurance within regulated pharmaceutical, biotech, clinical research, or consultancy environments.
* Strong auditing experience, covering internal audits, external audits, vendor audits, or investigator site audits.
* Solid understanding of Good Pharmacovigilance Practice, Good Clinical Practice, Quality Management Systems, and regulatory expectations.
* Demonstrated ability to perform root cause analysis and develop effective CAPA.
* Strong problem-solving skills, clear communication, and confidence engaging with clients and senior stakeholders.
* Experience coaching or guiding colleagues and contributing to a positive quality culture.
* Fluent English, written and spoken.
* Work remotely while contributing to a global life sciences consultancy .
* Lead quality operations that directly influence patient safety and regulatory compliance.
* Collaborate in a multicultural, inclusive, and innovative environment.
* Enjoy opportunities for career progression, professional development, and international exposure.
* Flexible Work Options : Remote working flexibility to support your lifestyle.
* Generous Time Off: Enjoy 5 weeks of holiday plus national holidays and 3 personal days to recharge.
* Home Office Support: Get support to create a productive home office setup.
* Bonuses: Benefit from an annual bonus program, spot bonuses, and employee-nominated recognition.
Arriello is an Equal Opportunity Employer. We are committed to creating a diverse, inclusive, and respectful workplace where all individuals are valued and treated with dignity. We encourage applicants from all backgrounds, including but not limited to race, colour, religion, gender, gender identity, sexual orientation, age, disability, national origin, or any other characteristic protected by law.
In line with our commitment, we provide reasonable accommodations to applicants with disabilities throughout the hiring process. If you require any accommodation, please contact us at recruitment@arriello.com.
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