Functional Quality Specialist II

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

📋 Description

• Assume responsibility for specific elements of quality evaluations on projects.

• Gather metrics and pinpoint quality trends.

• Assist with regular client quality assessments and any immediate client quality issues.

• Draft preliminary versions of Corrective and Preventive Actions.

• Examine samples of cases and safety reports intended for global regulatory submissions, as well as labeling and regulatory documents.

• Aid functional quality operations throughout the adverse events process.

• Oversee and evaluate expedited adverse events, product quality complaints, and medical inquiries, ensuring submission to clients and regulatory bodies within stipulated timelines.

• Manage assigned CAPAs and confirm actions are completed with appropriate documentation.

• Contribute to process evaluations, enhancements, and standards.

• Assist in designing and monitoring training schedules and materials.

• Initiate conversations around quality mistakes, identify areas for process enhancements, and share best practices.

• Support the coordination of client and external audits.

• Draft portions of Quality Management Plans.

• Provide assistance to clients during regulatory inspections at their sites.

• Encourage consistent, efficient, and quality-driven processes aligned with timelines, deliverables, and standard operating procedures.

• Address and review medical information inquiries, product quality complaints, and general questions.

• Evaluate recorded information obtained via telephone, email, fax, and other mediums.

• Implement drug safety data management processes, including reviewing call intakes, documenting dialogues, and following up on cases.

• Guide safety associates in managing voice calls when necessary.

• Monitor information and metrics, perform continuous quality control, conduct training, and reconcile data from various sources.

• Analyze data and propose or initiate strategies for process enhancement and excellence.

• Carry out additional tasks as assigned.

⛳️ Requirements

• Bachelor's, Master's, or PhD degree in Medicine, Alternative Medicine, Medical Science, Pharmaceutical Science, Nursing, Life Sciences, or a related field; relevant equivalent experience may be accepted in lieu of formal education.

• A minimum of three years of overall work experience in the pharmaceutical, biotechnology, or CRO sectors.

• At least one year of experience in peer or quality review.

• Familiarity with regulatory standards, including GPV and applicable EU and FDA guidelines.

• Comprehensive understanding of case processing and assessment.

• Knowledge of Quality Assurance principles.

• Awareness of lean methodology concepts.

• Proficient in using the Microsoft Office suite of applications.

• Experience in pharmacovigilance or safety writing.

• Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred.

• Preferred experience in assessing case/safety report quality from medical, scientific, and documentation viewpoints.

• Willingness to travel up to 10% of the time, including overnight stays when necessary.

🏝️ Benefits

• Option for remote work.

• Travel availability/overnight stays as necessary, up to 10% of the time.

• Commitment to equal employment opportunities and accommodations support.