Risk & Compliance Lead

This is a fully remote position, open to applicants in Poland, +3 more countries.

📋 Description

• Oversee established quality and compliance metrics, identifying risks, trends, and anomalies while escalating potential non-compliance or areas that require further attention.

• Conduct targeted reviews and analyses of metrics for specific clients or projects as necessary.

• Assist operational teams in managing Quality Events, including deviations, Corrective and Preventive Actions (CAPAs), and audit findings.

• Aid in investigations and Root Cause Analysis (RCA), helping to pinpoint underlying issues and appropriate corrective and preventive actions.

• Support operational teams in audit and inspection readiness, including preparation and assistance during client audits and regulatory inspections.

• Facilitate the effective management and resolution of audit and inspection findings, collaborating with relevant stakeholders.

• Contribute to initiatives aimed at system and process optimization, utilizing quality data and operational insights to identify areas for improvement.

• Collaborate across functions to foster strong risk awareness and cultivate a culture of quality, compliance, and continuous improvement.

⛳️ Requirements

• A Bachelor’s degree in life sciences, pharmacy, healthcare, law, business, quality, risk management, or a related discipline.

• A professional certification in quality, risk management, or compliance is advantageous.

• Relevant experience in Pharmacovigilance, Drug Safety, Quality, Compliance, or another regulated pharmaceutical or clinical research setting.

• A solid understanding of regulated operational processes and the associated quality and compliance requirements.

• Experience with quality metrics, deviations, CAPAs, audit findings, and Root Cause Analysis.

• Familiarity with audits, inspections, compliance reviews, or inspection-readiness activities.

• Strong analytical and problem-solving abilities, capable of identifying trends, outliers, and potential risks.

• Proven ability to work collaboratively with operational teams to investigate issues and develop practical, sustainable solutions.

• Excellent communication and stakeholder management skills, with the confidence to appropriately raise and escalate risks.

• Ability to manage competing priorities and carry actions through to completion.

• A proactive mindset regarding continuous improvement, quality, and compliance.

• Legal authorization to work in the country where the role is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.