Clinical Quality Associate Director

This is a fully remote position, open to applicants in Poland.

📋 Description

• Deliver expertise in quality and compliance to local study teams regarding company procedures, ICH-GCP, industry standards, and local regulations.

• Keep track of the regulatory environment and update clinical operations teams on compliance or study delivery modifications.

• Lead quality oversight and risk management efforts, including local Quality Control activities and compliance risk reduction.

• Assist in audit and inspection preparedness, including preparation, execution, responses, and follow-up.

• Advise teams on addressing findings from audits and inspections, as well as implementing corrective and preventive actions.

• Share insights from audits and inspections, bringing global and regional best practices to local teams.

• Identify, coordinate, or provide training for SMM colleagues and investigational site personnel.

• Aid in the implementation of global procedures and systems by offering local expertise, feedback, and guidance.

• Lead or participate in initiatives for quality and operational improvements related to systems, tools, SOPs, and processes.

• Supervise local procedural documents, including their development, maintenance, training, and archiving.

• Serve as the primary local liaison for Quality Assurance, fostering relationships across Quality, Clinical Operations, and R&D.

• Contribute to regional and global quality networks.

• Provide regulatory and quality insights to other departments and represent the organization in relevant forums.

• Assist in the evaluation and management of potential fraud or misconduct cases.

⛳️ Requirements

• Bachelor’s degree in a relevant field, preferably in Life Sciences, or an equivalent qualification.

• Prior experience in the pharmaceutical industry, ideally within Clinical Operations, Quality Assurance, or related clinical research.

• Strong understanding of the drug development process and GxP requirements, including ICH-GCP and applicable clinical trial regulations.

• Experience in clinical study operations, encompassing monitoring, study drug management, data management, and clinical quality oversight.

• Proven experience in supporting or leading audit and regulatory inspection readiness and activities.

• In-depth knowledge of quality management, risk-based thinking, process management, and continuous improvement.

• Capability to interpret complex regulatory and procedural requirements and convert them into practical operational guidance.

• Excellent business-level proficiency in both written and spoken English.

• Strong skills in communication, influencing, training, and facilitating workshops.

• Exceptional problem-solving, critical thinking, decision-making, and issue management abilities.

• Capacity to build trusted relationships and influence stakeholders across various functions, cultures, and organizational levels.

• Proactive mindset towards enhancing the quality, efficiency, cost, and speed of clinical trial delivery.

• Ability to operate effectively in both in-person and virtual settings.

• High degree of integrity, accountability, and ethical judgment.

• Willingness and ability to travel nationally and internationally as needed.

• Valid driving license where required by local employment regulations.

• Legal authorization to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension options.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

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

• An inclusive and accessible workplace.

• Reasonable accommodations provided during the recruitment process.