CQA Team Leader

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

📋 Description

• Oversee and lead a team of auditors.

• Facilitate the training, coaching, motivation, and professional development of team members.

• Assist clinical projects by conducting independent clinical audit assessments, managing inspections, performing quality reviews, and providing GCP advice.

• Manage daily performance, set objectives, handle performance management, support development, address administrative matters, and oversee hiring processes.

• Engage in the establishment of annual departmental goals and objectives.

• Direct audit planning and the creation of annual audit schedules and strategies.

• Contribute to the development of policies, procedures, guidelines, and standards, ensuring their implementation by the team.

• Ensure that planned audits are executed effectively, with optimal utilization and development of team resources.

• Guarantee the quality of conduct, reporting, and follow-up related to team audit activities.

• Offer GCP consultation, interpret regulations, and provide support for both internal and external clients.

• Take part in complex audits while coaching, training, and evaluating audit staff.

• Utilize predictive analytics and real-time data insights to identify and escalate risks in clinical trials.

• Lead the assessment of audit and inspection quality trends and alerts through Transversal Quality Reviews.

• Coordinate GCP assessment activities that are outsourced or contracted.

• Manage, support, and engage in regulatory inspection activities.

• Lead pre-inspection preparations, provide support during inspections, conduct site-level inspections, and follow up post-inspection.

• Develop and execute data quality controls utilizing AI and machine learning technologies.

• Participate in optimizing digital workflows, quality documents, tools, and processes to enhance efficiency.

⛳️ Requirements

• A bachelor’s degree in Life Sciences, Medical Sciences, Natural Sciences, or a related scientific field, or equivalent experience.

• At least 10 years of relevant experience with a bachelor's degree, or 5 years of relevant experience with an advanced degree.

• Minimum of 5 years in Clinical Quality Assessment and/or experience in Clinical Trials, including Monitoring or Clinical Trial Management.

• Proven track record of strong performance.

• Comprehensive knowledge of international regulations, guidelines, and Good Practices pertaining to the clinical field.

• Proficient in standard computerized software.

• Strong business communication skills in English.

• Experience in general management with technical/scientific personnel.

• Demonstrated expertise in digital transformation and agile methodologies.

• Proficient in clinical trial management systems, data visualization tools, and digital collaboration platforms.

• Ability to convert data into actionable insights and strategic recommendations.

• Effective communication skills across multicultural environments and in complex or sensitive situations.

• Strong people management and leadership capabilities.

• Expertise in clinical trial management systems and eClinical platforms.

• Proficiency in data visualization and analytics tools.

• Understanding digital health technologies and their application in clinical trials.

• In-depth knowledge of current regulations, guidelines, and good practices related to clinical development.

• Residency in the US or Puerto Rico.

🏝️ Benefits

• A supportive, future-focused team environment.

• Opportunities for promotion or lateral career transitions, both locally and internationally.

• A rewards package that acknowledges contributions.

• Comprehensive health and wellbeing benefits.

• Access to high-quality healthcare.

• Participation in prevention and wellness programs.

• At least 14 weeks of gender-neutral parental leave.

• Opportunities to collaborate with diverse teams across scientific, clinical, and digital disciplines.